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
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1, 6-10, and 13-22 have an effective filing date of 12/05/2017, corresponding to EP17205560.0.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/24/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly the information disclosure statement was considered by the examiner.
Claims 1, 6-10, and 13-22 are pending.
Claim 2 is canceled.
Claim 1 is currently amended.
Claims 8-10 and 13-22, previously withdrawn from consideration as a result of a restriction requirement, require similar limitations to claim 1. As such the restriction requirement among inventions I-III, as set forth in the Office action mailed on 11/26/2025, is hereby withdrawn and claims 8-10 and 13-22 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 1, 6-10, and 13-22 are under examination on the merits.
Rejections Withdrawn
35 U.S.C. 112(a)
The rejection of claims 1, 6, and 7 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn in view of the claim amendments, dated 06/25/2026. Claim 2 is canceled.
Rejections Maintained
Nonstatutory Double Patenting
The rejection of claims 1, 6, and 7 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, and 7 of U.S. Patent No. 11,639,496, is maintained. Applicant has requested that this rejection remain in abeyance at this point in prosecution.
Claim Objections
Line 6 of claim 10 recites “One or more shRNAs…” This line should begin with a lower case letter to read “one or more shRNAs…”
Claim Rejections
35 U.S.C. 112(b)
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.
Claim 10 is 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.
Line 8 of claim 10 reads, “and/or the composition further comprising…” When the claim is interpreted to read the phrase “and the composition further comprising,” the claim makes grammatical sense; however when the claim is interpreted to read the phrase “or the composition further comprising,” the claim does not make grammatical sense. Appropriate correction is required such that one skilled in the art can reasonably ascertain which alternatives were intended to be claimed.
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 8-10 and 13-22 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, 8-11, 13, and 14 of U.S. Patent No. 11,639,496.
Although the claims at issue are not identical, they are not patentably distinct from each other.
With respect to the instant claims 8-10, conflicting claim 8 recites “[a]n engineered immune cell comprising a nucleic acid molecule encoding a chimeric NKG2D receptor, wherein said chimeric NKG2D receptor comprises (i) a NKG2D receptor polypeptide that binds to at least one NKG2D ligand selected from MICA, MICB, ULBP1, ULBP2, ULBP3, ULBP4, ULBP5 and ULBP6 and (ii) a signaling moiety that transduces a signal in immune cells that express the chimeric NKG2D receptor, and one or more shRNAs and/or siRNAs that specifically bind to a nucleic acid encoding said NKG2D receptor polypeptide and/or that specifically bind to a nucleic acid encoding a NKG2D ligand selected from MICA, MICB, ULBP1, ULBP2, ULBP3, ULBP4, ULBP5 and ULBP6, wherein said shRNAs and/or siRNAs downregulate the expression of the NKG2D receptor and/or said NKG2D ligands.”
With respect to the instant claims 13 and 22, conflicting claim 11 recites “[a] method of treatment in a subject comprising a disease characterized by NKG2D expressing cells which are involved in the disease pathology comprising administering an effective amount of engineered immune cells according to claim 8.”
With respect to the instant claim 14, conflicting claims 13 and 14 recite “[a] method of treating a subject comprising a disease characterized by NKG2D expressing cells which are involved in the disease pathology, comprising administering the composition of claim 10…, wherein the disease is a cancer, characterized by NKG2D expressing cancer cells.
With respect to claims 15 and 18-20, conflicting claim 10 recites “[a] composition of immune cells comprising a nucleic acid molecule encoding a chimeric NKG2D receptor, wherein said chimeric NKG2D receptor comprises (i) a NKG2D receptor polypeptide that binds to a NKG2D ligand selected from MICA, MICB, ULBP1, ULBP2, ULBP3, ULBP4, ULBP5 and ULBP6 and (ii) a signaling moiety that transduces a signal in the immune cell that expresses the chimeric NKG2D receptor, and wherein the cells further comprise: one or more shRNAs or siRNAs directed against the nucleic acid encoding the NKG2D receptor comprised in the nucleic acid encoding the chimeric NKG2D receptor and/or one or more nucleic acids directed against at least one nucleic acid encoding a NKG2D ligand selected from MICA, MICB, ULBP1, ULBP2, ULBP3, ULBP4, ULBP5 and ULBP6; and/or the composition further comprises: one or more antibodies directed against the NKG2D receptor polypeptide in the chimeric NKG2D receptor and/or one or more antibodies directed against one or more of said NKG2D ligands; and/or an antibody or small molecule that specifically binds to a Phosphoinositide 3-kinase (PI3K) polypeptide which inhibits PI3K signaling.”
With respect to the instant claim 16 and 17, conflicting claims 1, 2, 4, and 5 recite “[a] method of reducing and/or preventing fratricide during the manufacturing of immune cells expressing a chimeric NKG2D receptor, wherein said chimeric NKG2D receptor comprises (i) a NKG2D receptor polypeptide that binds to at least one NKG2D ligand selected from MICA, MICB, ULBP1, ULBP2, ULBP3, ULBP4, ULBP5 and ULBP6 and (ii) a signaling moiety that transduces a signal in immune cells that express the chimeric NKG2D receptor, comprising effecting functional inhibition of NKG2D signaling during the manufacturing process of the cells, by one or more of the following: (i) contacting the immune cells expressing the chimeric NKG2D receptor during manufacturing with an antibody or small molecule that specifically binds to a Phosphoinositide 3-kinase (PI3K) polypeptide thereby inhibiting PI3K signaling; (ii) introducing into the immune cells express the chimeric NKG2D receptor during manufacturing at least one nucleic acid that specifically binds to a Phosphoinositide 3-kinase (PI3K) nucleic acid thereby inhibiting PI3K signaling; (iii) contacting the immune cells expressing a chimeric NKG2D receptor during manufacturing with at least one antibody specific to the NKG2D receptor polypeptide comprised in the chimeric NKG2D receptor and/or with at least one antibody specific to a NKG2D ligand selected from MICA, MICB, ULBP1, ULBP2, ULBP3, ULBP4, ULBP5 and ULBP6; or (iv) introducing into the immune cells during manufacturing at least one nucleic acid that specifically binds to the nucleic acid in the chimeric NKG2D receptor nucleic acid which encodes for said NKG2D receptor polypeptide or introducing at least one nucleic acid that specifically binds to a nucleic acid encoding a NKG2D ligand selected from MICA, MICB, ULBP1, ULBP2, ULBP3, ULBP4, ULBP5 and ULBP6, wherein the binding of said nucleic acid which specifically binds to said NKG2D receptor nucleic acid or to said NKG2D ligand nucleic acid downregulates the expression of the NKG2D receptor or said NKG2D ligand…, which results in at least one of (i) permanent or transient inhibition of one or more of the NKG2D ligands of the immune cells; (ii) transient inhibition of the chimeric NKG2D receptor; or (iii) transient inhibition of downstream signaling of the chimeric NKG2D receptor, wherein transient inhibition of PI3K signaling is effected by contacting the immune cells with an antibody or small molecule that binds to a Phosphoinositide 3-kinase (PI3K) polypeptide, wherein the small molecule or antibody is selected from LY294002 and idelalisib.”
With respect to claim 21, conflicting claims 8 and 9 recite “[a]n engineered immune cell comprising a nucleic acid molecule encoding a chimeric NKG2D receptor, wherein said chimeric NKG2D receptor comprises (i) a NKG2D receptor polypeptide that binds to at least one NKG2D ligand selected from MICA, MICB, ULBP1, ULBP2, ULBP3, ULBP4, ULBP5 and ULBP6 and (ii) a signaling moiety that transduces a signal in immune cells that express the chimeric NKG2D receptor, and one or more shRNAs and/or siRNAs that specifically bind to a nucleic acid encoding said NKG2D receptor polypeptide and/or that specifically bind to a nucleic acid encoding a NKG2D ligand selected from MICA, MICB, ULBP1, ULBP2, ULBP3, ULBP4, ULBP5 and ULBP6, wherein said shRNAs and/or siRNAs downregulate the expression of the NKG2D receptor and/or said NKG2D ligands…, wherein the immune cells comprise at least one of T cells, NK cells, NKT cells, stem cells and iPSCs.”
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON B MOSELEY II whose telephone number is (571)272-6221. The examiner can normally be reached on M-F, 9:00-6:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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