DETAILED ACTION
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 .
Status of Application, Amendments and/or Claims
The amendments of 21 July 2025, 05 November 2024, and 14 June 2024 have been entered in full. Claims 1-21 are cancelled and claims 22-41 are added. Claim 22 is amended. Claim 24 is also cancelled.
Claims 22, 23, and 25-41 are under consideration in the instant application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08 May 2026 (3); 22 December 2025; 28 August 2025; 19 May 2025; 31 January 2025; and 04 October 2024 (3) are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The replacement drawings were received on 14 June 2024. These drawings are acceptable.
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.
U.S. Patent No. 11,952,426
1. Claims 22, 23, 25-30, and 34-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,952,426 (cited on the IDS of 04 October 2024). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a method of treating multiple myeloma in a human subject comprising subcutaneously administering the same BCMAxCD3 bispecific antibody at the same doses and dosing schedule.
Claim 22 of the instant application, for example, recites a method of treating multiple myeloma in a human subject in need thereof, comprising subcutaneously administering a therapeutically effective amount of a BCMAxCD3 bispecific antibody to the subject to treat the multiple myeloma, wherein the BCMAxCD3 bispecific antibody comprises a BCMA binding domain comprising a first heavy chain (HC1) having the amino acid sequence of SEQ ID NO: 12 and a first light chain (LC1) having the amino acid sequence of SEQ ID NO: 13, and a CD3 binding domain comprising a second heavy chain (HC2) having the amino acid sequence of SEQ ID NO: 22 and a second light chain (LC2) having the amino acid sequence of SEQ ID NO: 23, wherein the method comprises administering two step-up doses of the BCMAxCD3 bispecific antibody followed by at least two 1500 μg/kg treatment doses of the BCMAxCD3 bispecific antibody, wherein said at least two treatment doses are administered about one week apart from each other, and wherein the method is effective in treating the multiple myeloma. Claims 27 and 35 of the instant application recite that the subject is relapsed or refractory to treatment with at least one prior anti-cancer treatment.
Meanwhile, claim 1 of the ‘426 patent recites a method of treating relapsed or refractory multiple myeloma in a human subject in need thereof, comprising administering a therapeutically effective amount of a BCMAxCD3 bispecific antibody to the subject to treat the cancer, wherein the subject is relapsed or refractory to treatment with at least one prior anti-cancer treatment, wherein the BCMAxCD3 bispecific antibody comprises a BCMA binding domain comprising a heavy chain variable region (VH) having the amino acid sequence of SEQ ID NO: 10 and a light chain variable region (VL) having the amino acid sequence of SEQ ID NO: 11, and a CD3 binding domain comprising a VH having the amino acid sequence of SEQ ID NO: 20 and a VL having the amino acid sequence of SEQ ID NO: 21, wherein the BCMAxCD3 bispecific antibody is administered subcutaneously at a dose of about 1500 μg/kg weekly, and wherein the method is effective in treating the multiple myeloma.
Claim 3 of the ‘426 patent recites that the BCMAxCD3 bispecific antibody comprises a BCMA binding domain comprising a first heavy chain (HC1) having the amino acid sequence of SEQ ID NO: 12 and a first light chain (LC1) having the amino acid sequence of SEQ ID NO: 13, and a CD3 binding domain comprising a second heavy chain (HC2) having the amino acid sequence of SEQ ID NO: 22 and a second light chain (LC2) having the amino acid sequence of SEQ ID NO: 23.
It is noted that the HC1, LC1, HC2, and LC2 amino acid sequences of SEQ ID NOs: 12, 13, 22, and 23 recited in the claims of the ‘426 patent are 100% identical to the same HC1, LC1, HC2, and LC2 amino acid sequences of SEQ ID NOs: 12, 13, 22, and 23 recited in the claims of the instant application.
Claim 23 of the instant application and claim 2 of the ‘426 patent recite that the BCMAxCD3 bispecific antibody is an IgG4 isotype.
Instant claim 25 and claim 4 of the ‘426 patent recite that the BCMAxCD3 bispecific antibody is teclistamab.
Claims 26 and 34 of the instant application and claim 5 of the ‘426 patent recite that the BCMAxCD3 bispecific antibody is administered for a time sufficient to achieve complete response, stringent complete response, a very good partial response, or a partial response.
Instant claims 28 and 36 and claim 7 of the ‘426 patent recite further comprising administering to the subject one or more additional anti-cancer therapies.
Instant claims 29 and 37 and claims 6 and 12 of the ‘426 patent recite that the subject is relapsed or refractory to treatment with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
Instant claims 30 and 38 recite that step-up doses are administered in amounts of 60 μg/kg and 300 μg/kg. Claim 13 of the ‘426 patent recites that step-up doses of about 60 μg/kg and about 300 μg/kg are administered to the subject prior to the dose of about 1500 μg/kg weekly.
U.S. Patent No. 12,098,210
2. Claims 22, 26, 27-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,098,210 (cited on the IDS of 04 October 2024). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a method of treating multiple myeloma in a human subject comprising subcutaneously administering the same BCMAxCD3 bispecific antibody at the same doses and dosing schedule.
Claim 22 of the instant application, for example, recites a method of treating multiple myeloma in a human subject in need thereof, comprising subcutaneously administering a therapeutically effective amount of a BCMAxCD3 bispecific antibody to the subject to treat the multiple myeloma, wherein the BCMAxCD3 bispecific antibody comprises a BCMA binding domain comprising a first heavy chain (HC1) having the amino acid sequence of SEQ ID NO: 12 and a first light chain (LC1) having the amino acid sequence of SEQ ID NO: 13, and a CD3 binding domain comprising a second heavy chain (HC2) having the amino acid sequence of SEQ ID NO: 22 and a second light chain (LC2) having the amino acid sequence of SEQ ID NO: 23, wherein the method comprises administering two step-up doses of the BCMAxCD3 bispecific antibody followed by at least two 1500 μg/kg treatment doses of the BCMAxCD3 bispecific antibody, wherein said at least two treatment doses are administered about one week apart from each other, and wherein the method is effective in treating the multiple myeloma.
Instant claim 28 recites further administering to the subject one or more additional anti-cancer therapies.
Instant claim 30 recites that the two step-up doses are administered in amounts of 60 μg/kg and 300 μg/kg.
Instant claim 31 recites that after the first two 1500 μg/kg treatment doses are administered about one week apart from each other, additional treatment doses of the BCMAxCD3 bispecific antibody are administered in amounts of up to 3000 μg/kg.
Instant claim 32 recites that after the first two 1500 μg/kg treatment doses are administered about one week apart from each other, additional treatment doses of the BCMAxCD3 bispecific antibody are administered once every two weeks, or once every three weeks, or once every month.
Instant claim 33 recites that after the first two 1500 μg/kg treatment doses are administered about one week apart from each other, additional treatment doses of the BCMAxCD3 bispecific antibody are administered once every two weeks, or once every three weeks, or once every month in amounts of up to 3000 μg/kg.
Meanwhile, claim 1 of the ‘210 patent recites a method of treating multiple myeloma in a human subject in need thereof, comprising administering to the subject a BCMAxCD3 bispecific antibody and an anti-CD38 antibody in 28-day treatment cycles, wherein the method comprises:
subcutaneously administering to the subject the BCMAxCD3 bispecific antibody in step-up doses of 0.06 mg/kg [60 μg/kg] and 0.3 mg/kg [300 μg/kg] followed by a dose of 1.5 mg/kg [1500 μg/kg] once per week during treatment cycle 1, a dose of 1.5 mg/kg [1500 μg/kg] once per week during treatment cycle 2, and a dose of 3 mg/kg [3000 μg/kg] once every two weeks beginning in treatment cycle 3, and
subcutaneously administering to the subject the anti-CD38 antibody at a dose of 1800 mg once per week during treatment cycles 1 and 2, once every two weeks during treatment cycles 3-6 and once every 4 weeks beginning in treatment cycle 7,
wherein the BCMAxCD3 bispecific antibody comprises:
(1) a BCMA binding domain comprising a heavy chain variable region (VH) having heavy chain complementarity determining regions (HCDRs) HCDR1, HCDR2 and HCDR3 of the amino acid sequences of SEQ ID NO: 18, SEQ ID NO: 19, and SEQ ID NO: 20, respectively, and a light chain variable region (VL) having light chain complementarity determining regions (LCDRs) LCDR1, LCDR2 and LCDR3 of the amino acid sequences of SEQ ID NO: 21, SEQ ID NO: 22, and SEQ ID NO: 23, respectively, and
(2) a CD3 binding domain comprising a VH having HCDR1, HCDR2 and HCDR3 of the amino acid sequences of SEQ ID NO: 28, SEQ ID NO: 29, and SEQ ID NO: 30, respectively, and a VL having LCDR1, LCDR2 and LCDR3 of the amino acid sequences of SEQ ID NO: 31, SEQ ID NO: 32, and SEQ ID NO: 33, respectively, wherein the method is effective in treating the multiple myeloma.
Claim 8 of the ‘210 patent recites administering the BCMAxCD3 bispecific antibody once every 4 weeks beginning in treatment cycle 7.
Claim 5 of the ‘210 patent recites that the BCMAxCD3 bispecific antibody comprises a BCMA binding domain comprising a first heavy chain (HC1) having the amino acid sequence of SEQ ID NO: 26, a first light chain (LC1) having the amino acid sequence of SEQ ID NO: 27, a second heavy chain (HC2) having the amino acid sequence of SEQ ID NO: 36, and a second light chain (LC2) having the amino acid sequence of SEQ ID NO: 37.
It is noted that the HC1, LC1, HC2, and LC2 amino acid sequences of SEQ ID NOs: 26, 27, 36, and 37 recited in the claims of the ‘210 patent are 100% identical to the HC1, LC1, HC2, and LC2 amino acid sequences of SEQ ID NOs: 12, 13, 22, and 23 recited in the claims of the instant application.
Instant claims 27 and 29 and claims 9 and 10 of the ‘210 patent recite that the subject is relapsed or refractory to at least one prior treatment (including a proteasome inhibitor or an immunomodulatory drug).
Copending Application No. 18/639,233
3. Claims 22, 23, 25-30, and 34-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-92 of copending Application No. 18/639,233. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a method of treating multiple myeloma in a human subject comprising subcutaneously administering the same BCMAxCD3 bispecific antibody at the same doses and dosing schedule.
Claim 22 of the instant application, for example, recites a method of treating multiple myeloma in a human subject in need thereof, comprising subcutaneously administering a therapeutically effective amount of a BCMAxCD3 bispecific antibody to the subject to treat the multiple myeloma, wherein the BCMAxCD3 bispecific antibody comprises a BCMA binding domain comprising a first heavy chain (HC1) having the amino acid sequence of SEQ ID NO: 12 and a first light chain (LC1) having the amino acid sequence of SEQ ID NO: 13, and a CD3 binding domain comprising a second heavy chain (HC2) having the amino acid sequence of SEQ ID NO: 22 and a second light chain (LC2) having the amino acid sequence of SEQ ID NO: 23, wherein the method comprises administering two step-up doses of the BCMAxCD3 bispecific antibody followed by at least two 1500 μg/kg treatment doses of the BCMAxCD3 bispecific antibody, wherein said at least two treatment doses are administered about one week apart from each other, and wherein the method is effective in treating the multiple myeloma.
Instant claims 28 and 36 recite further administering to the subject one or more additional anti-cancer therapies.
Meanwhile, claim 1 of the ‘233 application recites a method of treating multiple myeloma in a subject in need thereof, comprising administering to the subject a combination dosing regimen comprising a therapeutically effective amount of a BCMAxCD3 bispecific antibody and a therapeutically effective amount of a GPRCDxCD3 antibody.
Claim 12 of the ‘233 application, for example, recites that the BCMAxCD3 bispecific antibody comprises a first heavy chain (HC1) having at least 90% identity to the amino acid sequence of SEQ ID NO: 12, a first light chain (LC1) having at least 90% identity to the amino acid sequence of SEQ ID NO: 13, a second heavy chain (HC2) having at least 90% identity to the amino acid sequence of SEQ ID NO: 22 and a second light chain (LC2) having at least 90% identity to the amino acid sequence of SEQ ID NO: 23.
It is noted that the HC1, LC1, HC2, and LC2 amino acid sequences of SEQ ID NOs: 12, 13, 22, and 23 recited in the claims of the ‘426 patent are 100% identical to the same HC1, LC1, HC2, and LC2 amino acid sequences of SEQ ID NOs: 12, 13, 22, and 23 recited in the claims of the instant application.
Regarding step-up dosing (as recited in instant claim 22), claim 37 of the ‘233 application recites subcutaneously administering to the subject one or more step-up doses of the BCMAxCD3 bispecific antibody prior to administering a treatment dose of the BCMAxCD3 bispecific antibody. Claim 49 of the ‘233 application recites subcutaneously administering step-up doses of the BMCAxCD3 bispecific antibody 2-4 days apart from each other. Claims 30 and 38 of the instant application and claims 47-48 of the ‘233 application recite that the step-up doses are administered in amounts of 60 μg/kg and 300 μg/kg.
Claims 38 and 39 of the ‘233 application recite that administering to the subject a treatment dose of the BCMAxCD3 bispecific antibody weekly or every two weeks, respectively. Claim 42 of ‘233 recites administering the BCMAxCD3 bispecific antibody weekly at a treatment dose of about 1500 μg/kg.
Claim 23 of the instant application and claims 4 and 5 of the ‘233 application recite that the BCMAxCD3 bispecific antibody is an IgG4 isotype.
Claim 25 of the instant application and claim 15 of the ‘233 application recite that the BCMAxCD3 bispecific antibody is teclistamab.
Claims 27, 29, 35, and 37 of the instant application recite that the subject is relapsed or refractory to treatment with at least one prior anti-cancer treatment. Claims 30-35 of the ‘233 application recite that the subject has relapsed or refractory multiple myeloma with a prior line of therapy.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending Application No. 18/639,242
4. Claims 22 and 25-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 101-118 of copending Application No. 18/639,242. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a method of treating multiple myeloma in a human subject comprising subcutaneously administering the same BCMAxCD3 bispecific antibody at the same doses and dosing schedule.
Claim 22 of the instant application, for example, recites a method of treating multiple myeloma in a human subject in need thereof, comprising subcutaneously administering a therapeutically effective amount of a BCMAxCD3 bispecific antibody to the subject to treat the multiple myeloma, wherein the BCMAxCD3 bispecific antibody comprises a BCMA binding domain comprising a first heavy chain (HC1) having the amino acid sequence of SEQ ID NO: 12 and a first light chain (LC1) having the amino acid sequence of SEQ ID NO: 13, and a CD3 binding domain comprising a second heavy chain (HC2) having the amino acid sequence of SEQ ID NO: 22 and a second light chain (LC2) having the amino acid sequence of SEQ ID NO: 23, wherein the method comprises administering two step-up doses of the BCMAxCD3 bispecific antibody followed by at least two 1500 μg/kg treatment doses of the BCMAxCD3 bispecific antibody, wherein said at least two treatment doses are administered about one week apart from each other, and wherein the method is effective in treating the multiple myeloma.
Meanwhile, claim 101 of the ‘242 application recites a method of treating multiple myeloma in a subject in need thereof, comprising subcutaneously administering to the subject treatment doses of a BCMAxCD3 bispecific antibody on a weekly dosing schedule (QW) for at least one 28-day treatment cycle, and subsequently administering to the subject treatment doses of the BCMAxCD3 bispecific antibody on a bi-weekly dosing schedule (Q2W) for at least one 28-day treatment cycle, and subsequently administering to the subject treatment doses of the
BCMAxCD3 bispecific antibody on a monthly dosing schedule (Q4W), wherein the BCMAxCD3 bispecific antibody comprises a BCMA binding domain comprising the HCDR1 of SEQ ID NO: 4, the HCDR2 of SEQ ID NO: 5, the HCDR3 of SEQ ID NO: 6, the LCDR1 of SEQ ID NO: 7, the LCDR2 of SEQ ID NO: 8 and the LCDR3 of SEQ ID NO: 9, and a CD3 binding domain comprising the HCDR1 of SEQ ID NO: 14, the HCDR2 of SEQ ID NO: 15, the HCDR3 of SEQ ID NO: 16, the LCDR1 of SEQ ID NO: 17, the LCDR2 of SEQ ID NO: 18 and the LCDR3 of SEQ ID NO: 19, and wherein the method is effective in treating the multiple myeloma.
Claim 103 of the ‘242 application recites that the BCMAxCD3 bispecific antibody comprises a first heavy chain (HC1) having the amino acid sequence of SEQ ID NO: 12, a first light chain (LC1) having the amino acid sequence of SEQ ID NO: 13, a second heavy chain (HC2) having the amino acid sequence of SEQ ID NO: 22 and a second light chain (LC2) having the amino acid sequence of SEQ ID NO: 23.
It is noted that the HC1, LC1, HC2, and LC2 amino acid sequences of SEQ ID NOs: 12, 13, 22, and 23 recited in the claims of the ‘242 application are 100% identical to the same HC1, LC1, HC2, and LC2 amino acid sequences of SEQ ID NOs: 12, 13, 22, and 23 recited in the claims of the instant application.
Claim 25 of the instant application and claim 104 of ‘242 recite that the BCMAxCD3 bispecific antibody is teclistamab.
Claim 27 of the instant application and claims 105 and 112 of the ‘242 application recite that the subject is relapsed or refractory to treatment.
Claim 28 of the instant application and claim 110 of ‘242 recite further comprising administering an additional anti-cancer therapy.
Regarding the specific step-up doses, treatment doses, and timing limitations recited in instant claims 22, 30-33, and 38-41, claim 11 of the ‘242 application, for example, recites administering the BCMAxCD3 bispecific antibody in the following 28-day treatment cycles:
Cycle 1: 0.06 mg/kg [60 μg/kg] step-up dose on Day 2, 0.3 mg/kg [300 μg/kg] step-up dose on Day 4, 1.5 mg/kg [1500 μg/kg] step-up dose (also referred to as a treatment dose) on Day 8 and 1.5 mg/kg weekly (QW) thereafter;
Cycle 2: 1.5 mg/kg weekly (QW);
Cycles 3-6: 3 mg/kg [3000 μg/kg] biweekly (Q2W);
Cycle 7 and subsequent cycles: 3 mg/kg [3000 μg/kg] monthly (Q4W).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending Application No. 19/126,633
5. Claims 22, 25, 26, 28, 30-34, 36, and 38-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-122 of copending Application No. 19/126,633. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a method of treating multiple myeloma in a human subject comprising subcutaneously administering the same BCMAxCD3 bispecific antibody at the same doses and dosing schedule.
Claim 22 of the instant application, for example, recites a method of treating multiple myeloma in a human subject in need thereof, comprising subcutaneously administering a therapeutically effective amount of a BCMAxCD3 bispecific antibody to the subject to treat the multiple myeloma, wherein the BCMAxCD3 bispecific antibody comprises a BCMA binding domain comprising a first heavy chain (HC1) having the amino acid sequence of SEQ ID NO: 12 and a first light chain (LC1) having the amino acid sequence of SEQ ID NO: 13, and a CD3 binding domain comprising a second heavy chain (HC2) having the amino acid sequence of SEQ ID NO: 22 and a second light chain (LC2) having the amino acid sequence of SEQ ID NO: 23, wherein the method comprises administering two step-up doses of the BCMAxCD3 bispecific antibody followed by at least two 1500 μg/kg treatment doses of the BCMAxCD3 bispecific antibody, wherein said at least two treatment doses are administered about one week apart from each other, and wherein the method is effective in treating the multiple myeloma.
Meanwhile, claim 1 of the ‘633 application recites a method of treating cancer in a subject in need thereof, comprising administering a therapeutically effective amount of a BCMAxCD3 bispecific antibody, a therapeutically effective amount of an anti-CD38 antibody, and a therapeutically effective amount of an immunomodulatory drug to the subject for a time sufficient to treat the cancer. Claim 114 of ‘633 recites that the cancer is multiple myeloma. Claims 19 and 32 recite that the BCMAxCD3 bispecific antibody is administered subcutaneously. Claims 4, 67, and 84 of ‘633 recite that the BCMAxCD3 bispecific antibody comprises a first heavy chain (HC1) having the amino acid sequence of SEQ ID NO: 22, a first light chain (LC1) having the amino acid sequence of SEQ ID NO: 23, a second heavy chain (HC2) having the amino acid sequence of SEQ ID NO: 24 and a second light chain (LC2) having the amino acid sequence of SEQ ID NO: 25.
It is noted that the HC1, LC1, HC2, and LC2 amino acid sequences of SEQ ID NOs: 22, 23, 24, and 25 recited in the claims of the ‘633 application are 100% identical to the HC1, LC1, HC2, and LC2 amino acid sequences of SEQ ID NOs: 12, 13, 22, and 23 recited in the claims of the instant application.
Claim 25 of the instant application and claims 5 and 68, for example, of the ‘633 application recite that the BCMAxCD3 bispecific antibody is teclistamab.
Regarding the specific step-up doses recited in the instant claims, claims 11-13 of the ‘633 application recite that the method comprises administering a loading dose the BCMAxCD3 bispecific antibody, wherein the loading dose comprises 1, 2, 3, or more than 3 step-up doses.
Instant claim 30 recites the step-up dose comprises two step-up doses of the bispecific antibody administered in amounts of 60 μg/kg and 300 μg/kg. Claim 15 of ‘633 recites that the one or more step-up doses of the BCMAxCD3 bispecific antibody are selected from 60 µg/kg, 240 µg/kg, or 300 µg/kg.
Regarding the two 1500 μg/kg treatment doses of BCMAxCD3 bispecific antibody (one week apart) recited in instant claim 22, claim 10 of the ‘633 application recites that the bispecific antibody is administered at a frequency selected from daily, weekly, biweekly, once every four weeks or monthly. Claims 47, 48, and 64 of the ‘633 application recite treatment doses of the BCMAxCD3 bispecific antibody, including 1500 μg/kg. Regarding the treatment doses and timing limitations recited in instant claims 22, 31-33, and 39-41, claim 64(ii) of the ‘633 application, for example, recites that after one or more step-up doses, administering subcutaneously a treatment dose of the BCMAxCD3 bispecific antibody of about 720 µg/kg, 1500 µg/kg, 3000 µg/kg, or 6000 µg/kg, or any combination thereof, or of about 100 mg, 150 mg, 200 mg, 300 mg, or 450 mg, or any combination thereof at a frequency selected from weekly, biweekly, once every four weeks, or once a month.
Copending Application No. 19/581,761
6. Claims 22, 23, 25, 26, 30-34, 38-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-80 of copending Application No. 19/581,761. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a method of treating multiple myeloma in a human subject comprising subcutaneously administering the same BCMAxCD3 bispecific antibody at the same doses and dosing schedule.
Claim 22 of the instant application, for example, recites a method of treating multiple myeloma in a human subject in need thereof, comprising subcutaneously administering a therapeutically effective amount of a BCMAxCD3 bispecific antibody to the subject to treat the multiple myeloma, wherein the BCMAxCD3 bispecific antibody comprises a BCMA binding domain comprising a first heavy chain (HC1) having the amino acid sequence of SEQ ID NO: 12 and a first light chain (LC1) having the amino acid sequence of SEQ ID NO: 13, and a CD3 binding domain comprising a second heavy chain (HC2) having the amino acid sequence of SEQ ID NO: 22 and a second light chain (LC2) having the amino acid sequence of SEQ ID NO: 23, wherein the method comprises administering two step-up doses of the BCMAxCD3 bispecific antibody followed by at least two 1500 μg/kg treatment doses of the BCMAxCD3 bispecific antibody, wherein said at least two treatment doses are administered about one week apart from each other, and wherein the method is effective in treating the multiple myeloma.
Meanwhile, claim 1 of the ‘761 application recites a method of treating high-risk smoldering multiple myeloma in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a BCMAxCD3 bispecific antibody. Claim 11 of the ‘761 application recites that the BCMAxCD3 bispecific antibody comprises a first heavy chain (HC1) having the amino acid sequence of SEQ ID NO: 12, a first light chain (LC1) having the amino acid sequence of SEQ ID NO: 13, a second heavy chain (HC2) having the amino acid sequence of SEQ ID NO: 22 and a second light chain (LC2) having the amino acid sequence of SEQ ID NO: 23. Claim 19 recites that each dose of the BCMAxCD3 bispecific antibody is administered subcutaneously.
It is noted that the HC1, LC1, HC2, and LC2 amino acid sequences of SEQ ID NOs: 12, 13, 22, and 23 recited in the claims of the ‘761 application are 100% identical to the same HC1, LC1, HC2, and LC2 amino acid sequences of SEQ ID NOs: 12, 13, 22, and 23 recited in the claims of the instant application.
Instant claim 23 and claims 4 and 5 of the ‘761 application recite that the BCMAxCD3 bispecific antibody is an IgG4 isotype.
Claim 25 of the instant application and claim 15 of ‘761 recite that the BCMAxCD3 bispecific antibody is teclistamab.
Regarding step-up doses, claims 23 and 24 of the ‘761 application recite 1-3 step-up doses or two step-up doses, respectively, of the BCMAxCD3 bispecific antibody are administered. Claim 26 of the ‘761 application recites that the step-up phase comprises a first step-up dose of 0.06 mg/kg [60 μg/kg] of the BCMAxCD3 bispecific antibody and a second step-up dose of 0.3 mg/kg [300 μg/kg] of the BCMAxCD3 bispecific antibody.
Claim 30 of ‘761 recites that the step-up phase comprises subcutaneously administering two step-up doses and two treatment doses of the antibody.
Claim 31 of ‘761 recites that the step-up phase comprises subcutaneously administering two step-up doses and three treatment doses of the antibody.
Regarding the specific step-up doses, treatment doses, and timing limitations recited in instant claims 22, 30-33, and 38-41, claim 55 of the ‘761 application, for example, recites administering the BCMAxCD3 bispecific antibody in the following 28-day treatment cycles:
in Cycle 1, subcutaneously administering one or more step-up doses and then two or more weekly (QW) treatment doses of 1.5 mg/kg [1500 μg/kg]; and in one or more subsequent BCMAxCD3 treatment cycles, subcutaneously administering weekly (QW) treatment doses of 1.5 mg/kg, and then in one or more subsequent BCMAxCD3 treatment cycles, subcutaneously
administering bi-weekly (Q2W) treatment doses of 3.0 mg/kg [1500 μg/kg].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending Application No. 19/581,814
7. Claims 22, 23, and 25-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-176 of copending Application No. 19/581,814. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a method of treating multiple myeloma in a human subject comprising subcutaneously administering the same BCMAxCD3 bispecific antibody at the same doses and dosing schedule.
Claim 22 of the instant application, for example, recites a method of treating multiple myeloma in a human subject in need thereof, comprising subcutaneously administering a therapeutically effective amount of a BCMAxCD3 bispecific antibody to the subject to treat the multiple myeloma, wherein the BCMAxCD3 bispecific antibody comprises a BCMA binding domain comprising a first heavy chain (HC1) having the amino acid sequence of SEQ ID NO: 12 and a first light chain (LC1) having the amino acid sequence of SEQ ID NO: 13, and a CD3 binding domain comprising a second heavy chain (HC2) having the amino acid sequence of SEQ ID NO: 22 and a second light chain (LC2) having the amino acid sequence of SEQ ID NO: 23, wherein the method comprises administering two step-up doses of the BCMAxCD3 bispecific antibody followed by at least two 1500 μg/kg treatment doses of the BCMAxCD3 bispecific antibody, wherein said at least two treatment doses are administered about one week apart from each other, and wherein the method is effective in treating the multiple myeloma.
Meanwhile, claim 1 of the ‘814 application recites a method of treating multiple myeloma in a subject in need thereof, comprising treating the subject according to a therapeutically effective regimen that comprises sequential 28-day BCMAxCD3 treatment cycles, wherein:
one or more step-up doses of a BCMAxCD3 bispecific antibody are subcutaneously
administered to the subject during a step-up phase, and
treatment doses of the BCMAxCD3 bispecific antibody are subcutaneously
administered to the subject on a monthly dosing schedule (Q4W) starting from the first
BCMAxCD3 treatment cycle after the step-up phase.
Claim 12 of the ‘814 application recites, for example, wherein the BCMAxCD3 bispecific antibody comprises a first heavy chain (HC1) having at least 90% identity to the amino acid sequence of SEQ ID NO: 12, a first light chain (LC1) having at least 90% identity to the amino acid sequence of SEQ ID NO: 13, a second heavy chain (HC2) having at least 90%
identity to the amino acid sequence of SEQ ID NO: 22 and a second light chain (LC2) having
at least 90% identity to the amino acid sequence of SEQ ID NO: 23.
It is noted that the HC1, LC1, HC2, and LC2 amino acid sequences of SEQ ID NOs: 12, 13, 22, and 23 recited in the claims of the ‘814 application are 100% identical to the same HC1, LC1, HC2, and LC2 amino acid sequences of SEQ ID NOs: 12, 13, 22, and 23 recited in the claims of the instant application.
Claim 23 of the instant application and claims 4 and 5 of the ‘814 application recite that the BCMAxCD3 bispecific antibody is an IgG4 isotype.
Claim 25 of the instant application and claim 16 of the ‘814 application recite that the BCMAxCD3 bispecific antibody is teclistamab.
Instant claims 30 and 38 and claim 26 of the ‘814 application, for example, recite the step-up phase comprises two step-up doses of the bispecific antibody administered in amounts of 60 μg/kg and 300 μg/kg.
Regarding step-up doses, claims 30 and 31 of the ‘814 application recite two step-up doses, respectively, of the BCMAxCD3 bispecific antibody are administered. Claim 37 of the ‘814 application recites that the step-up phase comprises subcutaneously administering a first step-up dose of 0.06 mg/kg [60 μg/kg] of the BCMAxCD3 bispecific antibody, a second step-up dose of 0.3 mg/kg [300 μg/kg], a first treatment dose of 1.5 mg/kg [1500 μg/kg] and a second treatment dose of 1.5 mg/kg [1500 μg/kg]. Claim 42 recites that the second treatment dose is administered 5-9 days after the first treatment dose. Claim 43 of ‘814 recites that the second treatment dose is administered 7 days after the first treatment dose.
Regarding the treatment doses and timing limitations recited in instant claims 22, 31-33, and 39-41, claim 56 of the ‘814 application, for example, recites that during the step-up phase, a first dose of 0.06 mg/kg, a second dose of 0.3 mg/kg, a third dose of 1.5 mg/kg and a fourth dose of 1.5 mg/kg of the BCMAxCD3 bispecific antibody are subcutaneously administered to the subject, and a treatment dose of 3 mg/kg [3000 μg/kg] of the BCMAxCD3 bispecific antibody is subcutaneously administered to the subject every 4 weeks (Q4W) starting from the first BCMAxCD3 treatment cycle after the step-up phase.
Claims 28 and 36 of the instant application and claims 62-66, for example, of the ‘814 application recite further administering an additional anti-cancer therapy.
Claims 27, 29, 35, and 37 of the instant application recite that the subject is relapsed or refractory to treatment with at least one prior anti-cancer treatment. Claims 168-172 of the ‘814 application recite that the subject has relapsed or refractory multiple myeloma with a prior therapy.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowable.
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BEB
Art Unit 1647
19 August 2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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