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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 07/09/2026 has been entered.
Claims 1, 3-6, 8, 15-16, 20-22 and 24-30 are pending and under consideration.
Applicant’s IDS document filed on 07/09/2026 has been considered.
Claims 1, 20, 22, 26-27 and 30 are objected to because of the following informalities: Claims 1, 20, 22, 26-27 and 30 recite “PDL1” and “PD-L1” and it would be preferable if it was recited only one way. Appropriate correction is required.
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, 3-6, 8, 15-16, 20-22, 24-25 and 29-30 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 after amendment now recites:
A method for treating a tumor in a human subject in need thereof, said method comprising administering an anti-BTN3A antibody, in combination with an anti-PD1 or an anti-PDL1 antibody, wherein said subject is having a relapsed or refractory tumor to an anti-PD1 or an anti-PDL1 treatment, wherein said anti-BTN3A antibody comprises either (i) a heavy chain of SEQ ID NO:4 and a light chain of SEQ ID NO:6;(ii) a heavy chain of SEQ ID NO:4 and a light chain of SEQ ID NO:7;(iii) a heavy chain of SEQ ID NO:5 and a light chain of SEQ ID NO:6; or,(iv) a heavy chain of SEQ ID NO:5 and a light chain of SEQ ID NO:7; wherein said tumor is a solid tumor selected from the group consisting of bladder cancer, melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma; wherein said anti-PD1 or anti-PD-L1 antibody is selected from the group consisting of nivolumab, pembrolizumab, avelumab, durvalumab, cemiplimab, and atezolizumab.
After amendment it is unclear if the recitations of “an anti-PD1 or an anti-PDL1 antibody” and “an anti-PD1 or an anti-PDL1 treatment” and “said anti-PD1 or anti-PD-L1 antibody” are all referring to the same thing. Applicant has removed the recitation that the anti-PD1/PDL1 treatment is the anti-PD1 or anti-PD-L1 antibody in the current claim amendment. The recitations of claims 20, 22 and 30 are also unclear because it is not known if these recitations read on the treatment.
Correction is required.
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.
9. Claims 1, 3-6, 8, 15-16, 20-22 and 24-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 19/158,538 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-19 of 19/158,538 are directed to 1. (Currently amended) A method for treating cancer in a subject in need thereof, said method comprising administering a therapeutically effective amount of a BTN3A activating antibody to said subject, in combination with a therapeutically effective amount of an immune checkpoint inhibitor, wherein said BTN3A activating antibody , either:- comprises (a) a variable heavy chain (VH) polypeptide comprising an amino acid sequence that is at least about 95%, 96%, 97%, 98%, 99% or 100% identical to the SEQ ID NO: 1, and (b) a variable light chain (VL) polypeptide comprising an amino acid sequence that is at least about 95%, 96%,97%, 98%,99% or 100% identical to SEQ ID NO: 2 or SEQ ID NO: 3;- comprises HCDRsl-3 of SEQ ID NO:12-14 and LCDRsl-3 of SEQ ID NO:15-17;- comprises HCDRsl-3 of SEQ ID NO:18-20 and LCDRsl-3 of SEQ ID NO:21-23; or,- competes for binding with an antibody having a heavy chain of SEQ ID NO:4 and a light chain of SEQ ID NO:6, and wherein said immune checkpoint inhibitor is selected from the group consisting of LAG-3 inhibitors, TIGIT inhibitors and TIM-3 inhibitors, and, optionally, further in combination with PD-1 inhibitors of claim 1; said BTN3A activating antibody induces the activation of y6T cells of claim 2; wherein said BTN3A activating antibody comprises HCDRs1-3 of SEQ ID NO:12-14 and LCDRs1-3 of SEQ ID NO:15-17 of claim 4; wherein said BTN3A activating antibody is an antibody comprising or essentially consisting of a heavy chain of SEQ ID NO: 4 and a light chain of SEQ IDNO:6 of claim 5; wherein said BTN3A activating antibody comprises an IgG1 constant region with the triple mutations L247F L248E and P350S of claim 6; wherein said cancer is selected from the group consisting of melanoma (e.g. metastatic malignant melanoma), lung cancer (e.g. non-small cell lung cancer), breast cancer, prostate cancer, head and neck cancer (e.g. squamous cell carcinoma of head and neck), renal cancer, colorectal cancer, gastric cancer, esophageal cancer, liver cancer, pancreatic cancer, glioblastoma, ovarian cancer, cervical cancer, cholangiocarcinoma, bladder cancer, cancer of the kidney or ureter, sarcoma of soft tissue, and hematological malignancies including for example, acute myeloid leukemia, Hodgkin's lymphoma, multiple myeloma, diffuse large B-cell lymphoma (DLBCL), and indolent non-Hodgkin lymphoma (NHL) of claim 9; wherein said subject is refractory or relapsed after PD-1 inhibitor therapy of claim 10; wherein said BTN3A activating antibody is administered once every three weeks, or once every four weeks of claim 11; wherein the BTN3A activating antibody is administered intravenously, for example, at a unit dose of about 0.1 to about 200 mg of claim 12; the BTN3A activating antibody is administered intravenously at a unit dose of about 0.1 to about 200 mg for 1 to 22 cycles of claim 13; wherein said immune checkpoint inhibitor is an anti-LAG-3/anti-PD-1 bispecific antibody which is administered intravenously at a unit dose of about 100 to about 1000 mg of claim 14; and wherein said BTN3A antibody comprises a heavy chain of SEQ ID NO:4 and a light chain of SEQ ID NO:6, and said immune checkpoint inhibitor is nivolumab/relatlimab of claim 15.
Instant SEQ ID NOs 4 and 6 are 100% sequence identical to reference SEQ ID NOs 4 and 6.
The reference teachings anticipate the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10. No claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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July 25, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
Prosecution Insights