DETAILED ACTION
Claims 1, 3, and 7-14 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A preliminary amendment filed on 01/09/2025 amending claims 3, 4, 7 and 9-12 and cancelling claims 5 and 15 is acknowledged.
A preliminary amendment filed on 06/18/2026 cancelling claims 2, 4 and 6 is acknowledged.
Applicant’s election of Group I, claims 1, 3, 7-14, drawn in part to a method of improving the benefit to a patient of an adoptive cell transfer immunotherapy that targets an immunoglobulin light chain comprising administering a protein that has IgG cysteine protease or IgG endoglycosidase activity in combination with the adoptive cell transfer immunotherapy in the reply filed on 06/18/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1, 3 and 7-14 are at issue and will be examined only to the extent they encompass the elected invention.
Priority
This application is a 371 of PCT/EP2022/081841 filed on 11/14/2022 and claims domestic priority 35 U.S. C. 119(e) to provisional application No. 63/279,398 filed on 11/15/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/11/2024 is acknowledged.
The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the
information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 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.
Claims 1, 3, and 7-14 are 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.
Claim 1 (claims 3, 7-14 depending therefrom) is indefinite in the recitation of “improving the benefit to a patient” for the following reason. It is unclear what qualifies as a benefit to the patient. Correction is required.
Claim 7 is indefinite in the recitation of “wherein the adoptive cell transfer immunotherapy that targets an immunoglobulin light chain comprises administration of T-cells, natural killer cells or dendritic cells expressing a chimeric antigen receptor or a T-cell receptor”. Given the position of the commas and the use of the term “or”, it is unclear what the options are. For example, the options could be (i) T-cells, (ii) natural killer cells, (iii) dendritic cells expressing a chimeric antigen receptor and (iv) a T-cell receptor. Alternatively, the options could be (i) T-cells, (ii) natural killer cells, and (iii) dendritic cells expressing a chimeric antigen receptor or a T-cell receptor. Still further, the options could be (i) T-cells, (ii) natural killer cells, and (iii) dendritic cells, such that any of the options of cells are expressing a chimeric antigen receptor or a T-cell receptor. As such, the metes and bounds of the claim cannot be determined. Correction is required.
Claims 8, 11-12 and 14 are indefinite in the recitation of the phrase “such as” for the following reason. It is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). As such, the metes and bounds of the claims cannot be determined. Correction is required.
Claim 11 recites the limitation "wherein the disease" in the method of claim 1. There is insufficient antecedent basis for this limitation in the claim. Correction is required.
Claim 14 is indefinite in the recitation of a broader range followed by a narrow range “at least 85%...99%”. Correction is required.
Closest Prior Art
The prior are does not teach a method of improving the benefit to a patient of an adoptive cell transfer immunotherapy that targets an immunoglobulin light chain comprising administering a protein that has IgG cysteine protease or IgG endoglycosidase activity in combination with the adoptive cell transfer immunotherapy. While Scheinberg et al. (WO2021021989A1, published 02/04/2021, Applicant Cited Reference in IDS filed on 09/11/2024, #4) teaches the use of CAR T-cells for adoptive cell transfer, which co-expression of an IgG degrading enzyme, wherein the IgG degrading enzyme is selected from IdeS, IdeZ, EndoS and SpeB (see pg. 2, second paragraph, Summary of the Invention), it does not provide the limitation of the CAR T-cells targeting immunoglobulin light chain. Vera et al. (Blood, Vol. 108, 12, 2006, published December 2006, Applicant Cited Reference in IDS filed on 09/11/2024, #16) teaches adoptive cell transfer immunotherapy using T lymphocytes redirected against the κ light chain of human immunoglobulin to kill B lymphocyte-derived malignant cells. However, Vera et al. does not teach the combination of adoptive cell transfer immunotherapy that targets an immunoglobulin light chain with an IgG cysteine protease or IgG endoglycosidase. The combination of adoptive cell transfer immunotherapy with administering a protein with IgG cysteine protease or IgG endoglycosidase activity is novel and combination of Scheinberg et al. and Vera et al. would be the result of hindsight.
Conclusion
No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALTON KIEFER, PhD whose telephone number is (571)272-1235. The examiner can normally be reached M-F 7:30-5 EST.
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/DALTON KIEFER, PhD/Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
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