Clean it up and post.
DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendments and remarks filed 06/11/2026 are acknowledged. Claims 1 is amended. Claims 2 and 10 are cancelled. Claims 1, 3-9 and 11-14 are pending and under examination. Claims 15-20 are withdrawn.
Withdrawn Rejections
3. The rejection of claims 1 and 3-14 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paragraph, as failing to comply with the written description requirement, is withdrawn in light of the Applicant’s amendments thereto. See page 3 of the previous office action.
4. The rejection of claims 1-9, 13 and 14 under 35 U.S.C 102(a)(2) for being unpatentable over Mataraza, et al. (U.S. 10155813 B2), is withdrawn in light of Applicant’s amendments thereto. See pages 15-18 of the previous office action.
Information Disclosure Statement
5. The information disclosure statement submitted 06/11/2026 is considered, unless indicated otherwise.
Maintained Rejections
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.
6. Claim 1-2 and 10-13 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 13 and 19-21 of copending Application No.
17866867.
This rejection is maintained for reasons of record (pp. 20-25, Office action mailed
12 March 2026) and for the reasons discussed below. For convenience, the rejection
is repeated herein, modified to adhere to the amendments:
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claim 1 directs a method for treating a solid tumor in a patient in need thereof, the method comprising: administering to the patient a pharmaceutically effective amount of an anti-BTLA antibody or antigen binding fragment thereof; wherein the solid tumor to melanoma, colorectal cancer (CRC), sarcoma, neuroendocrine tumor (NET), squamous cell carcinoma (SCC) of the parotid gland, head and neck squamous cell carcinomas (HNSCCs), follicular lymphoma, Hodgkin's lymphoma, and diffuse large B cell lymphoma (DLBCL); and wherein the anti-BTLA antibody or antigen binding fragment thereof comprises a light chain variable region of LCDR1 having the amino acid sequence of SEQ ID NO: 1, LCDR2 having the amino acid sequence of SEQ ID NO: 2, LCDR3 having the amino acid sequence of SEQ ID NO: 3; and further comprises a heavy chain variable region of HCDR1 having the amino acid sequence of SEQ ID NO: 4, HCDR2 having the amino acid sequence of SEQ ID NO: 5, HCDR3 having the amino acid sequence of SEQ ID NO: 6
This is recited by claims 1, 19 and 20 of copending application ‘867 direct to a method for treating or preventing BTLA-mediated diseases, such as tumors, comprising administering to a subject or patient in need thereof a therapeutically effective amount of the pharmaceutical composition which comprises anti-BTLA antibody or an antigen binding fragment thereof. Claim 21 of copending application ‘867 recites the tumors can include melanoma, Hodgkin’s disease, non-Hodgkin’s lymphoma, squamous cell carcinoma, cancer of the endocrine system, and head or neck cancer. Instant SEQ NO: 1-6 are 100% to the light chain and heavy amino acid sequence of copending application ‘867 SEQ ID NO: 11 and 12 (claim 9).
Instant SEQ ID NO: 1 is 100% identical to copending application ‘329 SEQ ID NO: 12:
Query Match 100.0%; Score 79; DB 1; Length 219;
Best Local Similarity 100.0%;
Matches 16; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 KSSQSLLDSDGKTYLN 16
||||||||||||||||
Db 24 KSSQSLLDSDGKTYLN 39
Instant SEQ ID NO: 2 is 100% identical to copending application ‘329 SEQ ID NO: 12:
Query Match 100.0%; Score 31; DB 1; Length 219;
Best Local Similarity 100.0%;
Matches 7; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 LVSKLDS 7
|||||||
Db 55 LVSKLDS 61
Instant SEQ ID NO: 9 is 100% identical to copending application ‘329 SEQ ID NO: 12:
Query Match 100.0%; Score 59; DB 1; Length 219;
Best Local Similarity 100.0%;
Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 WQGTYFPYT 9
|||||||||
Db 94 WQGTYFPYT 102
Instant SEQ ID NO: 4 is 100% identical to copending application ‘329 SEQ ID NO: 11:
Query Match 100.0%; Score 32; DB 1; Length 446;
Best Local Similarity 100.0%;
Matches 5; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 HTYAH 5
|||||
Db 31 HTYAH 35
Instant SEQ ID NO: 5 is 100% identical to copending application ‘329 SEQ ID NO: 11:
Query Match 100.0%; Score 96; DB 1; Length 446;
Best Local Similarity 100.0%;
Matches 17; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RIDPANGNTKYDPKFQG 17
|||||||||||||||||
Db 50 RIDPANGNTKYDPKFQG 66
Instant SEQ ID NO: 6 is 100% identical to copending application ‘329 SEQ ID NO: 11:
Query Match 100.0%; Score 56; DB 1; Length 446;
Best Local Similarity 100.0%;
Matches 10; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DHYGSSLLDY 10
||||||||||
Db 99 DHYGSSLLDY 108
Instant claim 11 directed to the method of claim 1, wherein the anti-BTLA antibody or antigen binding fragment thereof comprises a light chain variable region sequence of SEQ ID NO: 7 and a heavy chain variable region sequence of SEQ ID NO: 8. Instant SEQ ID NO: 7 and 9 are 100% identical to the light chain and heavy amino acid sequence of copending application ‘867 SEQ ID NO: 11 and 12.
Instant SEQ ID NO: 7 is 100% identical to copending application ‘329 SEQ ID NO: 12:
Query Match 100.0%; Score 591; DB 1; Length 219;
Best Local Similarity 100.0%;
Matches 112; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DVVMTQTPLSLSVTPGQPASISCKSSQSLLDSDGKTYLNWFQQRPGQSPRRLIYLVSKLD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DVVMTQTPLSLSVTPGQPASISCKSSQSLLDSDGKTYLNWFQQRPGQSPRRLIYLVSKLD 60
Qy 61 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCWQGTYFPYTFGQGTKLEIK 112
||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCWQGTYFPYTFGQGTKLEIK 112
Instant SEQ ID NO: 8 is 100% identical to copending application ‘329 SEQ ID NO: 11:
Query Match 100.0%; Score 633; DB 1; Length 446;
Best Local Similarity 100.0%;
Matches 119; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKLSCKASGYNFKHTYAHWVRQAPGQGLEWIGRIDPANGNTKY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGASVKLSCKASGYNFKHTYAHWVRQAPGQGLEWIGRIDPANGNTKY 60
Qy 61 DPKFQGRATMTADTASNTAYLELSSLRSEDTAVYYCVADHYGSSLLDYWGQGTLVTVSS 119
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DPKFQGRATMTADTASNTAYLELSSLRSEDTAVYYCVADHYGSSLLDYWGQGTLVTVSS 119
Instant claim 12 direct to the method of claim 1, wherein the anti-BTLA antibody or antigen binding fragment thereof comprises a light chain sequence of SEQ ID NO: 9 and a heavy chain sequence of SEQ ID NO: 10. Instant SEQ ID NO: 9 and 10 are 100% identical to the light chain and heavy amino acid sequence of copending application ‘867 SEQ ID NO: 11 and 12 (claim 9).
Instant SEQ ID NO: 9 is 100% identical to copending application ‘329 SEQ ID NO: 12:
Query Match 100.0%; Score 1144; Length 219;
Best Local Similarity 100.0%;
Matches 219; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DVVMTQTPLSLSVTPGQPASISCKSSQSLLDSDGKTYLNWFQQRPGQSPRRLIYLVSKLD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DVVMTQTPLSLSVTPGQPASISCKSSQSLLDSDGKTYLNWFQQRPGQSPRRLIYLVSKLD 60
Qy 61 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCWQGTYFPYTFGQGTKLEIKRTVAAPSV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCWQGTYFPYTFGQGTKLEIKRTVAAPSV 120
Qy 121 FIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 FIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSL 180
Qy 181 SSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 219
|||||||||||||||||||||||||||||||||||||||
Db 181 SSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 219
Instant SEQ ID NO: 10 is 100% identical to copending application ‘329 SEQ ID NO: 11:
Query Match 100.0%; Score 2379; Length 446;
Best Local Similarity 100.0%;
Matches 446; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKLSCKASGYNFKHTYAHWVRQAPGQGLEWIGRIDPANGNTKY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGASVKLSCKASGYNFKHTYAHWVRQAPGQGLEWIGRIDPANGNTKY 60
Qy 61 DPKFQGRATMTADTASNTAYLELSSLRSEDTAVYYCVADHYGSSLLDYWGQGTLVTVSSA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DPKFQGRATMTADTASNTAYLELSSLRSEDTAVYYCVADHYGSSLLDYWGQGTLVTVSSA 120
Qy 121 STKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSG 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 STKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSG 180
Qy 181 LYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVF 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 LYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVF 240
Qy 241 LFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYR 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 LFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYR 300
Qy 301 VVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKN 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 VVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKN 360
Qy 361 QVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGN 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 QVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGN 420
Qy 421 VFSCSVMHEALHNHYTQKSLSLSLGK 446
||||||||||||||||||||||||||
Db 421 VFSCSVMHEALHNHYTQKSLSLSLGK 446
Instant claim 13 recites the anti-BTLA antibody or antigen binding fragment thereof is in a composition comprises with a solubilizer and stabilizer in a solution. Claim 1 of copending application ‘867 recites a pharmaceutical composition comprising a histidine buffer, which is a stabilizer, an anti-BTLA antibody or antigen binding fragment thereof, and polysorbate, which is a type of solubilizer.
Applicant Arguments
A) Applicant argues the instant application is patentably distinct from Application No.17/866,867. Application argues the copending application teaches a pharmaceutical composition and specific components.
B) Applicant argues the pharmaceutical composition recites histidine buffer, specific stabilizer and specific surfactant. Applicant argues there is a mismatch in the scope of protection between the two application. Applicant argues the technical contribution in the copending application lies in the formulation stability. Applicant argues the technical contribution for the instant application lies in the clinical therapeutic efficacy.
C) Applicant argues claims 19-21 of ’867 application is withdrawn and not pending and thus, there are no claims that teach the antibody and the method simultaneously.
Response to Arguments
Applicant’s arguments (pages 11-12, remarks received 06/11/2026) have been fully considered but are not found persuasive for the following reasons.
A) Applicant argues the copending application teaches a pharmaceutical composition and specific components, however, the copending application teaches a method for treating or preventing BTLA-mediated diseases by administering a pharmaceutical composition comprising an anti-BTLA antibody, and said disease are tumors such as melanoma, Hodgkin’s disease, non-Hodgkin’s lymphoma, squamous cell carcinoma, cancer of the endocrine system, and head or neck cancer . The antibody and disease types are identical to the instant application.
B) Applicant argues the pharmaceutical composition recites various components, such as a buffer, stabilizer and surfactant and that there is a mismatch in the scope. However, instant claim 13 recites that the composition can comprise a solubilizer and a stabilizer in the solution. Examiner respectfully disagrees with the argument that there is a scope mismatch, as both applications teach a method to treat the same population, with administration of the same antibody.
C) Applicant’s arguments of copending application claims 19-21 are withdrawn and not pending and thus, there are no claims that teach the antibody and the method simultaneously. Withdrawn claims are subject to possible rejoinder and are still considered pending.
New rejections
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. Claims 1, 5-9, 11-12, 14 are rejected under 35 U.S.C. 102(a)(2) as being unpatentable over TopAlliance Biosciences, known hereinafter TopAlliance (Safety, Tolerability and Pharmacokinetics of a Monoclonal Antibody Specific to B-and T-Lymphocyte Attenuator (BTLA) as Monotherapy and in Combination With an Anti-PD1 Monoclonal Antibody for Injection in Subjects With Advanced Malignancies Clinicaltrials.Gov, clinicaltrials.gov/study/NCT04137900?tab=history&a=7#version-content-panel. Accessed 25 Aug. 2026., publicly available 04/09/2021)
PLEASE NOTE: The specification (paragraph 49) and the remarks filed (6/11/2026) state that TAB004 is the same antibody taught in the instant claims. The specification states that TAB004 comprises a light sequence of SEQ ID NO 9 and a heavy chain of SEQ ID NO 10. The CDRs and light and heavy chain variable region are within the heavy and light chain sequence of SEQ ID NO 9 and 10.
The instant claims teach a method for treating a solid tumor in a patient in need thereof, the method comprising: administering to the patient a pharmaceutically effective amount of an anti-BTLA antibody or antigen binding fragment thereof, wherein the solid tumor is one or more tumors selected from the group consisting of melanoma, colorectal cancer (CRC), sarcoma, neuroendocrine tumor (NET), squamous cell carcinoma (SCC) of the parotid gland, head and neck squamous cell carcinomas (HNSCCs), follicular lymphoma, Hodgkin's lymphoma, and diffuse large B cell lymphoma (DLBCL); and the anti-BTLA antibody or antigen binding fragment thereof comprises a light chain variable region of LCDR1 having the amino acid sequence of SEQ ID NO: 1, LCDR2 having the amino acid sequence of SEQ ID NO: 2, LCDR3 having the amino acid sequence of SEQ ID NO: 3; and further comprises a heavy chain variable region of HCDR1 having the amino acid sequence of SEQ ID NO: 4, HCDR2 having the amino acid sequence of SEQ ID NO: 5, HCDR3 having the amino acid sequence of SEQ ID NO: 6.
TopAlliance teach a method of administering TAB004 as monotherapy via I.V infusion and in combination with toripalimab (anti pd-1 antibody) to treat in subjects with selected advanced solid malignancies (non-small cell lung cancer [NSCLC], melanoma, renal cell carcinoma (RCC), urothelial carcinoma (UC), or other tumors), including lymphoma, and to evaluate the recommended Phase 2 dose (brief summary and detailed description). TAB004 is disclosed antibody of the instant application which comprises sequences of the claims including SEQ ID NO: 1-6 (CDRS), SEQ ID NO 7-8 (variable region sequences) and full-length sequences (SEQ ID NO: 9 and 10). Thus, instant claims 1, 7, 8 11, 12 and 14 are anticipated.
TopAlliance further teaches subjects in part C must have received all standard therapy for advanced or metastatic disease known to confer clinical benefit (criteria section). Thus, instant claims 5 and 6 are anticipated which teach that the anti-BTLA antibody is used as an adjuvant therapy and the patient has received at least one prior line of therapy. Regarding instant claim 9, TopAlliance teaches the same antibody, administered to the same patient population, thus, the properties of anti-BTLA expressed in instant claim 9 would be inherent properties. It is well settled that “[T]he
discovery of a previously unappreciated property of a prior art composition, or of a scientific
explanation for the prior art’s functioning, does not render the old composition patentably new
to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947
(Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is
inherently present in the prior art does not necessarily make the claim patentable (emphasis
added); see In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393
F.3d 1253, 1258, 73 USPQ2d 1364, 1368. Additionally, "Products of identical chemical
composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15
USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.
Therefore, if the prior art teaches the identical chemical structure, the properties applicant
discloses and/or claims are necessarily present
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
8. Claims 1, 3-9, 11-12, 14 are rejected under 35 U.S.C. 103 as being unpatentable over TopAlliance Biosciences, known hereinafter TopAlliance (Safety, Tolerability and Pharmacokinetics of a Monoclonal Antibody Specific to B-and T-Lymphocyte Attenuator (BTLA) as Monotherapy and in Combination With an Anti-PD1 Monoclonal Antibody for Injection in Subjects With Advanced Malignancies Clinicaltrials.Gov, clinicaltrials.gov/study/NCT04137900?tab=history&a=7#version-content-panel. Accessed 25 Aug. 2026., publicly available 04/09/2021) in view of Derré, et al. (Derré L, Rivals JP, Jandus C, Pastor S, Rimoldi D, Romero P, Michielin O, Olive D, Speiser DE. BTLA mediates inhibition of human tumor-specific CD8+ T cells that can be partially reversed by vaccination. J Clin Invest. 2010 Jan;120(1):157-67. doi: 10.1172/JCI40070. Epub 2009 Dec 28. PMID: 20038811; PMCID: PMC2799219.)
PLEASE NOTE: The specification (paragraph 49) and the remarks filed (6/11/2026) state that TAB004 is the same antibody taught in the instant claims. The specification states that TAB004 comprises a light sequence of SEQ ID NO 9 and a heavy chain of SEQ ID NO 10. The CDRs and light and heavy chain variable region are within the heavy and light chain sequence of SEQ ID NO 9 and 10.
The instant claims teach a method for treating a solid tumor in a patient in need thereof, the method comprising: administering to the patient a pharmaceutically effective amount of an anti-BTLA antibody or antigen binding fragment thereof, wherein the solid tumor is one or more tumors selected from the group consisting of melanoma, colorectal cancer (CRC), sarcoma, neuroendocrine tumor (NET), squamous cell carcinoma (SCC) of the parotid gland, head and neck squamous cell carcinomas (HNSCCs), follicular lymphoma, Hodgkin's lymphoma, and diffuse large B cell lymphoma (DLBCL); and the anti-BTLA antibody or antigen binding fragment thereof comprises a light chain variable region of LCDR1 having the amino acid sequence of SEQ ID NO: 1, LCDR2 having the amino acid sequence of SEQ ID NO: 2, LCDR3 having the amino acid sequence of SEQ ID NO: 3; and further comprises a heavy chain variable region of HCDR1 having the amino acid sequence of SEQ ID NO: 4, HCDR2 having the amino acid sequence of SEQ ID NO: 5, HCDR3 having the amino acid sequence of SEQ ID NO: 6.
TopAlliance teach a method of administering TAB004 as monotherapy via I.V infusion and in combination with toripalimab (anti pd-1 antibody) to treat subjects with selected advanced solid malignancies (non-small cell lung cancer [NSCLC], melanoma, renal cell carcinoma (RCC), urothelial carcinoma (UC), or other tumors), including lymphoma, and to evaluate the recommended Phase 2 dose (brief summary and detailed description). TAB004 is disclosed antibody of the instant application which comprises sequences of the claims including SEQ ID NO: 1-6 (CDRS), SEQ ID NO 7-8 (variable region sequences) and full-length sequences (SEQ ID NO: 9 and 10). Thus, instant claims 1, 7, 8 11, 12 and 14 are anticipated.
TopAlliance further teaches subjects in part C must have received all standard therapy for advanced or metastatic disease known to confer clinical benefit (criteria section). Thus, instant claims 5 and 6 are anticipated which teach that the anti-BTLA antibody is used as an adjuvant therapy and the patient has received at least one prior line of therapy. Regarding instant claim 9, TopAlliance teaches the same antibody, administered to the same patient population, thus, the properties of anti-BTLA expressed in instant claim 9 would be inherent properties. It is well settled that “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable (emphasis added); see In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368. Additionally, "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.
Therefore, if the prior art teaches the identical chemical structure, the properties applicant
discloses and/or claims are necessarily present
TopAlliance does not teach the solid tumor expresses at least about 1%-95% HVEM and CD8 as recited in instant claims 3 and 4.
However, Derré, et al. teach teaches a solid tumor (melanoma) that co-expresses HVEM and CD8. Derré teach that HVEM is expressed by melanoma cells in situ, reporting by immunohistochemistry on paraffin embedded metastases that 50% of metastases were stronger positive and 25% were moderate positive (Table 1 and Figure. 3c). Derré further teach that 26 of 40 melanoma cells lines expressed HVEM (Fig. 3, A and B). Derré further teaches that these HVEM expressing melanoma tumors are infiltrated by the CD8+ T cells, including tumor antigen specific CD8+ T cells present in tumor infiltrated lymph nodes (Fig. 2, C and D). Under broadest reasonable interpretation, the recited “solid tumor co-expresses HVEM and CD8” reads on a solid tumor tissue in which HVEM is expressed by the tumors cells and CD8 is expressed by tumor infiltrating T cells within that tumor, as taught by Derré.
It would have been obvious to one of ordinary skill in the art at the time of the invention to apply the anti-BTLA antibody taught by TopAlliance to treat HVEM and CD8 co-expressing melanoma as taught by Derré. One would have been motivated to do so because Derré that the HVEM-BTLA interaction functionally inhibits tumor specific CD8+ T cells in HVEM expressing melanoma, suppressing cytokine production, and proliferation, and that interfering with this inhibitory interaction restores tumor specific CD8+ T cell function (abstract, Fig 3D, Fig. 6 B-E). Applying the method to a tumor known to co-express HVEM and to contain CD8+ tumor specific T cells would therefore have been expected to yield predicable results. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.
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.
9. Claim 1 and 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, 11 and 12 of U.S. Patent No. 12110329 B2 (issued Oct. 8, 2024).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 1 directs to a method for treating a solid tumor in a patient in need thereof, the method comprising: administering to the patient a pharmaceutically effective amount of an anti-BTLA antibody or antigen binding fragment thereof, wherein the solid tumor is one or more tumors selected from the group consisting of melanoma, colorectal cancer (CRC), sarcoma, neuroendocrine tumor (NET), squamous cell carcinoma (SCC) of the parotid gland, head and neck squamous cell carcinomas (HNSCCs), follicular lymphoma, Hodgkin's lymphoma, and diffuse large B cell lymphoma (DLBCL); and the anti-BTLA antibody or antigen binding fragment thereof comprises a light chain variable region of LCDR1 having the amino acid sequence of SEQ ID NO: 1, LCDR2 having the amino acid sequence of SEQ ID NO: 2, LCDR3 having the amino acid sequence of SEQ ID NO: 3; and further comprises a heavy chain variable region of HCDR1 having the amino acid sequence of SEQ ID NO: 4, HCDR2 having the amino acid sequence of SEQ ID NO: 5, HCDR3 having the amino acid sequence of SEQ ID NO: 6..
U.S Patent No. 329’ teaches an isolated anti-BTLA antibody (claim 1), a pharmaceutical composition of the anti-BTLA antibody (claim 11), and a method for treating a BTLA-mediated disease such as cancer (claim 12), with CDRs of SEQ ID NO: 10-16 (claim 1) that are 100% identical to instant SEQ ID NO: 1-6, and a light chain and heavy chain variable region of SEQ ID NO: 47 and 45 (claim 2), which are 100% identical to instant SEQ ID NO: 7 and 8.
Conclusion
10. No claims are allowed
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Syed J Abbas whose telephone number is (571)272-0015. The examiner can normally be reached M-Th, 9:00AM-4:00PM.
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/SYED J ABBAS/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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