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 .
1. The Amendment filed May 18, 2026 in response to the Office Action of February 20, 2026, is acknowledged and has been entered. Claims 1-5 and 9-23 are pending. Claims 6-8 are canceled. Claims 1, 4, 5, 9-12 are amended.
Claim Objections
2. Claims 13-23 remain objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, claims 13-23 have not been further treated on the merits.
Claims 1-5 and 9-12 are further examined below.
Response to Arguments
3. Applicants argue they amended claims 4 and 9-23 to remove all improper multiple dependencies, such that each of the claims now depends solely from a single preceding claim.
4. The arguments have been considered but are not persuasive. Contrary to arguments, claims 13-23 were not amended to depend solely from a single preceding claim. The claims objected to depend from any of the foregoing (preceding) claims, and the preceding claims encompass multiple dependent claims.
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.
5. Claims 1-5 and 9-12 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/253,677 (reference application) in view of WO 2019/170131, Yu et al, published September 2019 (see English translation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims an isolated IgG antibody, comprising: two identical heavy chains each comprising (a) a hinge region comprising an amino acid sequence of: -(X₁)-C-(X₂)-CPPCP-, wherein X₁ is a polypeptide segment having 0-7 amino acid residues each independently selected from any amino acid residue that is not a cysteine residue, and X₂ is a polypeptide segment having 2-7 amino acid residues each independently selected from any amino acid residue that is not a cysteine residue; and (b) a CH1 domain located upstream of and connected to the hinge region, the CH1 domain comprising a cysteine at the position of 142 according to the IMGT numbering scheme; the IgG antibody further comprising two identical kappa light chains; wherein the CH1 domain of the IgG antibody has the sequence of that of the CH1 domain of a native human IgG1 antibody with the mutation S142C; wherein the amino acid sequence comprised in the hinge is SEQ ID NO:10 that is 100% identical to instant SEQ ID NO:25, or is SEQ ID NO:28 that is 100% identical to instant SEQ ID NO:26 (see sequence alignments below); wherein the antibody binds to CD73 and is a pharmaceutical; wherein the antibody is conjugated to a drug such as MMAE; and wherein the antibody is reduced at the H-H disulfide bond between each of the cysteine residues in the hinge region to obtain free sulfhydryls for conjugation to a chemical linker containing a terminal thiol reactive group for conjugation to a cytotoxic drug to each of the two heavy chains of the antibody.
The copending application claims the antibody binds to CD73 but does not claim the CDR sequences of a CD73 antibody.
Yu teaches anti-CD73 IgG therapeutic antibodies comprising VH SEQ ID NO:31 that comprises instant SEQ ID NO:1 and CDR SEQ ID NOs:5+6+7 (see sequence alignments below); and comprising VL SEQ ID NO:36 comprising instant SEQ ID NO:2 and CDR SEQ ID NOs:8+9 (see sequence alignment below) (see English translation p.17- 20; Examples 16 and 19). Yu teaches a therapeutic IgG anti-CD73 antibody comprising instant CDR SEQ ID NOs:5+6+7 and 8+9 as set forth above. Yu further teaches anti-CD73 IgG therapeutic antibodies comprising VH SEQ ID NO:38 that comprises instant SEQ ID NO:3 and CDR SEQ ID NOs:11+12+13 (see sequence alignments below); and comprising VL SEQ ID NO:43 comprising instant SEQ ID NO:4 and CDR SEQ ID NOs:14+15+16 (see sequence alignment below).
Yu teaches the anti-CD73 antibody can comprise a free cysteine for linkage to a drug to form an antibody drug conjugate (ADC) (see English translation p. 7, 22-24). Yu teaches engineering the anti-CD73 antibody to make a drug conjugate, including by reducing at the H-H disulfide bond between each of the cysteine residues in the hinge region of the heavy chain to obtain free sulfhydryls for conjugation to a chemical linker containing a terminal thiol reactive group for conjugation to a cytotoxic drug to each of the two heavy chains of the antibody. Yu demonstrates conjugating the CD73 antibody to a cytotoxic drug MMAE through the paired cysteines of the IgG antibody (see English translation p. 7-8, 22, 25-26; Examples 23-24).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to utilize the CDR, VH, and VL sequences of Yu in the antibody of the copending application. One of ordinary skill in the art would have been motivated to, and have a reasonable expectation of success to because: (1) the copending application claims their hinge-modified IgG antibody binds CD73 and is used for drug conjugation and pharmaceuticals; and (2) Yu teaches known therapeutic anti-CD73 IgG antibody CDR, VH, and VL sequences, the antibody is used for drug conjugation and pharmaceuticals, and teaches methods for engineering the antibodies utilizing the sequences.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant SEQ ID NO:25 aligned with Application 18/253,677 SEQ ID NO:10:
RESULT 1
US-18-253-677-10
Sequence 10, US/18253677
Publication No. US20240075154A1
GENERAL INFORMATION
APPLICANT: BLISS BIOPHARMACEUTICAL (HANGZHOU) CO., LTD.
TITLE OF INVENTION: ENGINEERED ANTIBODY, ANTIBODY-DRUG CONJUGATE, AND USE THEREOF
FILE REFERENCE: P21408907C
CURRENT APPLICATION NUMBER: US/18/253,677
CURRENT FILING DATE: 2023-05-19
PRIOR APPLICATION NUMBER: PCT/CN2020/130409
PRIOR FILING DATE: 2020-11-20
NUMBER OF SEQ ID NOS: 32
SEQ ID NO 10
LENGTH: 18
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: BB0500-2g&BB0801 Hinge Sequences
Query Match 100.0%; Score 114; Length 18;
Best Local Similarity 100.0%;
Matches 18; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EPPKSCDKTHTVECPPCP 18
||||||||||||||||||
Db 1 EPPKSCDKTHTVECPPCP 18
Instant SEQ ID NO:26 aligned with Application 18/253,677 SEQ ID NO:28:
RESULT 1
US-18-253-677-28
Sequence 28, US/18253677
Publication No. US20240075154A1
GENERAL INFORMATION
APPLICANT: BLISS BIOPHARMACEUTICAL (HANGZHOU) CO., LTD.
TITLE OF INVENTION: ENGINEERED ANTIBODY, ANTIBODY-DRUG CONJUGATE, AND USE THEREOF
FILE REFERENCE: P21408907C
CURRENT APPLICATION NUMBER: US/18/253,677
CURRENT FILING DATE: 2023-05-19
PRIOR APPLICATION NUMBER: PCT/CN2020/130409
PRIOR FILING DATE: 2020-11-20
NUMBER OF SEQ ID NOS: 32
SEQ ID NO 28
LENGTH: 18
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: BR0301&BR0302 Hinge Sequences
Query Match 100.0%; Score 111; Length 18;
Best Local Similarity 100.0%;
Matches 18; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EPPKSDCKTKTVECPPCP 18
||||||||||||||||||
Db 1 EPPKSDCKTKTVECPPCP 18
Instant VH SEQ ID NO:3 aligned with Yu SEQ ID NO:38 (CDRs1-3 underlined):
BGT03430
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
ID BGT03430 standard; protein; 119 AA.
XX
AC BGT03430;
XX
DT 31-OCT-2019 (first entry)
XX
DE Humanized anti-CD73 antibody mAb004-VH_HuG0 VH region, SEQ ID 38.
XX
KW CD73; antimicrobial-gen.; autoimmune disease; cancer; cytostatic;
KW diagnostic test; heavy chain variable region; humanized antibody;
KW immuno-diagnosis; immunoconjugate; immunosuppressive; infectious disease;
KW metabolic disorder; metabolic-gen.; monoclonal antibody;
KW prophylactic to disease; therapeutic.
XX
OS Mus musculus.
OS Homo sapiens.
OS Chimeric.
XX
CC PN WO2019170131-A1.
XX
CC PD 12-SEP-2019.
XX
CC PF 07-MAR-2019; 2019WO-CN077369.
XX
PR 07-MAR-2018; 2018CN-10188351.
PR 24-MAY-2018; 2018CN-10506111.
XX
CC PA (UYFU ) UNIV FUDAN.
XX
CC PI Yu K, Jin R, Liu L;
XX
DR WPI; 2019-78351Y/74.
XX
CC PT New heavy chain variable region of antibody useful for preparing a
CC PT detection reagent, a test plate or a kit and for preventing or treating
CC PT disease associated with CD73, comprises three complementarity determining
CC PT region.
XX
CC PS Claim 13; SEQ ID NO 38; 97pp; Chinese.
XX
CC The present invention relates to a novel antibody heavy chain variable
CC region, useful in preparing an antibody-drug conjugate and in diagnosing,
CC treating or preventing disease associated with CD73. The antibody heavy
CC chain variable region comprises complementarity determining region CDRs
CC of SEQ ID NOs: 1-3, 10-12 and 21-23 (see BGT03393-BGT03395, BGT03402-
CC BGT03404 and BGT03413-BGT03415). The invention also provides: an antibody
CC light chain variable region comprising CDRs of SEQ ID NOs: 4-6, 13-15 and
CC 24-26 (see BGT03396-BGT03398, BGT03405-BGT03407 and BGT03416-BGT03418);
CC an antibody heavy chain and light chain; a recombinant protein comprising
CC antibody heavy chain variable region, light chain variable region, heavy
CC chain and light chain, and an optional tag sequence; a chimeric antigen
CC receptor (CAR) construct comprising ScFv segment of monoclonal antibody
CC specifically binding to CD73; a recombinant immune cell expressing an
CC exogenous CAR construct; the antibody-drug conjugate comprising the
CC antibody, and a coupling moiety bound to the antibody moiety; and a
CC pharmaceutical composition comprising the antibody, immune cell or
CC antibody conjugate, and a pharmaceutically acceptable carrier. The
CC disease associated with CD73 is selected from the group consisting of
CC cancer, autoimmune disease, metabolic-related disease and infectious
CC disease.
XX
SQ Sequence 119 AA;
Query Match 100.0%; Score 631; Length 119;
Best Local Similarity 100.0%;
Matches 119; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKVSCKASGYTLTSYWMHWVRQAPGQGLEWMGEINPSQGRSNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGASVKVSCKASGYTLTSYWMHWVRQAPGQGLEWMGEINPSQGRSNY 60
Qy 61 NEKFKSRVTMTRDTSTSTVYMELSSLRSEDTAVYYCARRGVSGNYFDYWGQGTLVTVSS 119
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NEKFKSRVTMTRDTSTSTVYMELSSLRSEDTAVYYCARRGVSGNYFDYWGQGTLVTVSS 119
Instant VL SEQ ID NO:4 aligned with Yu SEQ ID NO:43 (CDRs1-3 underlined):
RESULT 1
BGT03435
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
ID BGT03435 standard; protein; 107 AA.
XX
AC BGT03435;
XX
DT 31-OCT-2019 (first entry)
XX
DE Humanized anti-CD73 antibody mAb004-VK_HuG2 VL region, SEQ ID 43.
XX
KW CD73; antimicrobial-gen.; autoimmune disease; cancer; cytostatic;
KW diagnostic test; humanized antibody; immuno-diagnosis; immunoconjugate;
KW immunosuppressive; infectious disease; light chain variable region;
KW metabolic disorder; metabolic-gen.; monoclonal antibody;
KW prophylactic to disease; therapeutic.
XX
OS Mus musculus.
OS Homo sapiens.
OS Chimeric.
XX
FH Key Location/Qualifiers
FT Region 24..34
FT /label= CDR1
FT Region 50..56
FT /label= CDR2
FT Region 89..97
FT /label= CDR3
XX
CC PN WO2019170131-A1.
XX
CC PD 12-SEP-2019.
XX
CC PF 07-MAR-2019; 2019WO-CN077369.
XX
PR 07-MAR-2018; 2018CN-10188351.
PR 24-MAY-2018; 2018CN-10506111.
XX
CC PA (UYFU ) UNIV FUDAN.
XX
CC PI Yu K, Jin R, Liu L;
XX
DR WPI; 2019-78351Y/74.
XX
CC PT New heavy chain variable region of antibody useful for preparing a
CC PT detection reagent, a test plate or a kit and for preventing or treating
CC PT disease associated with CD73, comprises three complementarity determining
CC PT region.
XX
CC PS Claim 13; SEQ ID NO 43; 97pp; Chinese.
XX
CC The present invention relates to a novel antibody heavy chain variable
CC region, useful in preparing an antibody-drug conjugate and in diagnosing,
CC treating or preventing disease associated with CD73. The antibody heavy
CC chain variable region comprises complementarity determining region CDRs
CC of SEQ ID NOs: 1-3, 10-12 and 21-23 (see BGT03393-BGT03395, BGT03402-
CC BGT03404 and BGT03413-BGT03415). The invention also provides: an antibody
CC light chain variable region comprising CDRs of SEQ ID NOs: 4-6, 13-15 and
CC 24-26 (see BGT03396-BGT03398, BGT03405-BGT03407 and BGT03416-BGT03418);
CC an antibody heavy chain and light chain; a recombinant protein comprising
CC antibody heavy chain variable region, light chain variable region, heavy
CC chain and light chain, and an optional tag sequence; a chimeric antigen
CC receptor (CAR) construct comprising ScFv segment of monoclonal antibody
CC specifically binding to CD73; a recombinant immune cell expressing an
CC exogenous CAR construct; the antibody-drug conjugate comprising the
CC antibody, and a coupling moiety bound to the antibody moiety; and a
CC pharmaceutical composition comprising the antibody, immune cell or
CC antibody conjugate, and a pharmaceutically acceptable carrier. The
CC disease associated with CD73 is selected from the group consisting of
CC cancer, autoimmune disease, metabolic-related disease and infectious
CC disease.
XX
SQ Sequence 107 AA;
Query Match 100.0%; Score 558; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSLSASVGDRVTITCKASQDINTYLSWFQQKPGKSPKSLIYRSNILVSGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSLSASVGDRVTITCKASQDINTYLSWFQQKPGKSPKSLIYRSNILVSGVPS 60
Qy 61 RFSGSGSGQDYTLTISSLQPEDFATYYCLQYDEFPYTFGGGTKLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGQDYTLTISSLQPEDFATYYCLQYDEFPYTFGGGTKLEIK 107
Instant VH CDR SEQ ID NOs:5+6+7 aligned with Yu SEQ ID NO:31
RESULT 5
BGT03423
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
ID BGT03423 standard; protein; 118 AA.
XX
AC BGT03423;
XX
DT 31-OCT-2019 (first entry)
XX
DE Humanized anti-CD73 antibody mAb004-VH_HuG.3 VH region, SEQ ID 31.
XX
KW CD73; antimicrobial-gen.; autoimmune disease; cancer; cytostatic;
KW diagnostic test; heavy chain variable region; humanized antibody;
KW immuno-diagnosis; immunoconjugate; immunosuppressive; infectious disease;
KW metabolic disorder; metabolic-gen.; monoclonal antibody;
KW prophylactic to disease; therapeutic.
XX
OS Mus musculus.
OS Homo sapiens.
OS Chimeric.
XX
CC PN WO2019170131-A1.
XX
CC PD 12-SEP-2019.
XX
CC PF 07-MAR-2019; 2019WO-CN077369.
XX
PR 07-MAR-2018; 2018CN-10188351.
PR 24-MAY-2018; 2018CN-10506111.
XX
CC PA (UYFU ) UNIV FUDAN.
XX
CC PI Yu K, Jin R, Liu L;
XX
DR WPI; 2019-78351Y/74.
XX
CC PT New heavy chain variable region of antibody useful for preparing a
CC PT detection reagent, a test plate or a kit and for preventing or treating
CC PT disease associated with CD73, comprises three complementarity determining
CC PT region.
XX
CC PS Claim 13; SEQ ID NO 31; 97pp; Chinese.
XX
CC The present invention relates to a novel antibody heavy chain variable
CC region, useful in preparing an antibody-drug conjugate and in diagnosing,
CC treating or preventing disease associated with CD73. The antibody heavy
CC chain variable region comprises complementarity determining region CDRs
CC of SEQ ID NOs: 1-3, 10-12 and 21-23 (see BGT03393-BGT03395, BGT03402-
CC BGT03404 and BGT03413-BGT03415). The invention also provides: an antibody
CC light chain variable region comprising CDRs of SEQ ID NOs: 4-6, 13-15 and
CC 24-26 (see BGT03396-BGT03398, BGT03405-BGT03407 and BGT03416-BGT03418);
CC an antibody heavy chain and light chain; a recombinant protein comprising
CC antibody heavy chain variable region, light chain variable region, heavy
CC chain and light chain, and an optional tag sequence; a chimeric antigen
CC receptor (CAR) construct comprising ScFv segment of monoclonal antibody
CC specifically binding to CD73; a recombinant immune cell expressing an
CC exogenous CAR construct; the antibody-drug conjugate comprising the
CC antibody, and a coupling moiety bound to the antibody moiety; and a
CC pharmaceutical composition comprising the antibody, immune cell or
CC antibody conjugate, and a pharmaceutically acceptable carrier. The
CC disease associated with CD73 is selected from the group consisting of
CC cancer, autoimmune disease, metabolic-related disease and infectious
CC disease.
XX
SQ Sequence 118 AA;
Query Match 86.9%; Score 163.4; Length 118;
Best Local Similarity 40.3%;
Matches 31; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 NYYIY--------------WIYPGNLNIKYNEKFKG------------------------ 22
||||| |||||||||||||||||
Db 31 NYYIYWVRQAPGQRLEWMGWIYPGNLNIKYNEKFKGRVTITADTSASTAYMELSSLRSED 90
Qy 23 --------DDNYAWFAY 31
|||||||||
Db 91 TAVYYCARDDNYAWFAY 107
Instant VH SEQ ID NO:1 aligned with Yu SEQ ID NO:31
RESULT 1
BGT03423
XX
AC BGT03423;
XX
DT 31-OCT-2019 (first entry)
XX
DE Humanized anti-CD73 antibody mAb004-VH_HuG.3 VH region, SEQ ID 31.
XX
KW CD73; antimicrobial-gen.; autoimmune disease; cancer; cytostatic;
KW diagnostic test; heavy chain variable region; humanized antibody;
KW immuno-diagnosis; immunoconjugate; immunosuppressive; infectious disease;
KW metabolic disorder; metabolic-gen.; monoclonal antibody;
KW prophylactic to disease; therapeutic.
XX
OS Mus musculus.
OS Homo sapiens.
OS Chimeric.
XX
CC PN WO2019170131-A1.
XX
CC PD 12-SEP-2019.
XX
CC PF 07-MAR-2019; 2019WO-CN077369.
XX
PR 07-MAR-2018; 2018CN-10188351.
PR 24-MAY-2018; 2018CN-10506111.
XX
CC PA (UYFU ) UNIV FUDAN.
XX
CC PI Yu K, Jin R, Liu L;
XX
DR WPI; 2019-78351Y/74.
XX
CC PT New heavy chain variable region of antibody useful for preparing a
CC PT detection reagent, a test plate or a kit and for preventing or treating
CC PT disease associated with CD73, comprises three complementarity determining
CC PT region.
XX
CC PS Claim 13; SEQ ID NO 31; 97pp; Chinese.
XX
CC The present invention relates to a novel antibody heavy chain variable
CC region, useful in preparing an antibody-drug conjugate and in diagnosing,
CC treating or preventing disease associated with CD73. The antibody heavy
CC chain variable region comprises complementarity determining region CDRs
CC of SEQ ID NOs: 1-3, 10-12 and 21-23 (see BGT03393-BGT03395, BGT03402-
CC BGT03404 and BGT03413-BGT03415). The invention also provides: an antibody
CC light chain variable region comprising CDRs of SEQ ID NOs: 4-6, 13-15 and
CC 24-26 (see BGT03396-BGT03398, BGT03405-BGT03407 and BGT03416-BGT03418);
CC an antibody heavy chain and light chain; a recombinant protein comprising
CC antibody heavy chain variable region, light chain variable region, heavy
CC chain and light chain, and an optional tag sequence; a chimeric antigen
CC receptor (CAR) construct comprising ScFv segment of monoclonal antibody
CC specifically binding to CD73; a recombinant immune cell expressing an
CC exogenous CAR construct; the antibody-drug conjugate comprising the
CC antibody, and a coupling moiety bound to the antibody moiety; and a
CC pharmaceutical composition comprising the antibody, immune cell or
CC antibody conjugate, and a pharmaceutically acceptable carrier. The
CC disease associated with CD73 is selected from the group consisting of
CC cancer, autoimmune disease, metabolic-related disease and infectious
CC disease.
XX
SQ Sequence 118 AA;
Query Match 100.0%; Score 636; Length 118;
Best Local Similarity 100.0%;
Matches 118; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKVSCKTSGYTFTNYYIYWVRQAPGQRLEWMGWIYPGNLNIKY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGASVKVSCKTSGYTFTNYYIYWVRQAPGQRLEWMGWIYPGNLNIKY 60
Qy 61 NEKFKGRVTITADTSASTAYMELSSLRSEDTAVYYCARDDNYAWFAYWGQGTLVTVSS 118
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NEKFKGRVTITADTSASTAYMELSSLRSEDTAVYYCARDDNYAWFAYWGQGTLVTVSS 118
Instant VL SEQ ID NO:2 aligned with Yu SEQ ID NO:36 (CDR1 and CDR2 underlined):
RESULT 1
BGT03428
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
ID BGT03428 standard; protein; 107 AA.
XX
AC BGT03428;
XX
DT 31-OCT-2019 (first entry)
XX
DE Humanized anti-CD73 antibody mAb004-VK_HuG.1 VL region, SEQ ID 36.
XX
KW CD73; antimicrobial-gen.; autoimmune disease; cancer; cytostatic;
KW diagnostic test; humanized antibody; immuno-diagnosis; immunoconjugate;
KW immunosuppressive; infectious disease; light chain variable region;
KW metabolic disorder; metabolic-gen.; monoclonal antibody;
KW prophylactic to disease; therapeutic.
XX
OS Mus musculus.
OS Homo sapiens.
OS Chimeric.
XX
FH Key Location/Qualifiers
FT Region 24..34
FT /label= CDR1
FT Region 50..56
FT /label= CDR2
FT Region 89..97
FT /label= CDR3
XX
CC PN WO2019170131-A1.
XX
CC PD 12-SEP-2019.
XX
CC PF 07-MAR-2019; 2019WO-CN077369.
XX
PR 07-MAR-2018; 2018CN-10188351.
PR 24-MAY-2018; 2018CN-10506111.
XX
CC PA (UYFU ) UNIV FUDAN.
XX
CC PI Yu K, Jin R, Liu L;
XX
DR WPI; 2019-78351Y/74.
XX
CC PT New heavy chain variable region of antibody useful for preparing a
CC PT detection reagent, a test plate or a kit and for preventing or treating
CC PT disease associated with CD73, comprises three complementarity determining
CC PT region.
XX
CC PS Claim 13; SEQ ID NO 36; 97pp; Chinese.
XX
CC The present invention relates to a novel antibody heavy chain variable
CC region, useful in preparing an antibody-drug conjugate and in diagnosing,
CC treating or preventing disease associated with CD73. The antibody heavy
CC chain variable region comprises complementarity determining region CDRs
CC of SEQ ID NOs: 1-3, 10-12 and 21-23 (see BGT03393-BGT03395, BGT03402-
CC BGT03404 and BGT03413-BGT03415). The invention also provides: an antibody
CC light chain variable region comprising CDRs of SEQ ID NOs: 4-6, 13-15 and
CC 24-26 (see BGT03396-BGT03398, BGT03405-BGT03407 and BGT03416-BGT03418);
CC an antibody heavy chain and light chain; a recombinant protein comprising
CC antibody heavy chain variable region, light chain variable region, heavy
CC chain and light chain, and an optional tag sequence; a chimeric antigen
CC receptor (CAR) construct comprising ScFv segment of monoclonal antibody
CC specifically binding to CD73; a recombinant immune cell expressing an
CC exogenous CAR construct; the antibody-drug conjugate comprising the
CC antibody, and a coupling moiety bound to the antibody moiety; and a
CC pharmaceutical composition comprising the antibody, immune cell or
CC antibody conjugate, and a pharmaceutically acceptable carrier. The
CC disease associated with CD73 is selected from the group consisting of
CC cancer, autoimmune disease, metabolic-related disease and infectious
CC disease.
XX
SQ Sequence 107 AA;
Query Match 100.0%; Score 568; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSLSASVGDRVTITCKASQDVSTAVAWYQQKPGKAPKLLIYWTNTRHTGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSLSASVGDRVTITCKASQDVSTAVAWYQQKPGKAPKLLIYWTNTRHTGVPS 60
Qy 61 RFSGSGSGTDHTLTISSLQPEDFATYYCQQHYSTPFTFGQGTKLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDHTLTISSLQPEDFATYYCQQHYSTPFTFGQGTKLEIK 107
Response to Arguments
6. Applicants request this rejection be held in abeyance because the copending application 18/253,677 has not yet been patented and its claims might be amended to a patentably distinct invention.
7. The arguments have been considered but are not persuasive. The rejection is maintained for the reasons of record, no terminal disclaimer has been filed, and the claims of the copending application have not been amended to reflect a patentably distinct invention.
8. All other objections and rejections recited in the Office Action mailed February 20, 2026 are hereby withdrawn in view of claim amendments and arguments.
9. Conclusion: No claim is allowed.
Conclusion
10. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA B GODDARD whose telephone number is (571)272-8788. The examiner can normally be reached Mon-Fri, 7am-3:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Laura B Goddard/Primary Examiner, Art Unit 1642
Prosecution Insights