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 .
DETAILED ACTION
Claim Status
The amendment filed on January 22, 2024 is acknowledged. Claims 3-4, 6-11, 15-20 have been amended. There are no new or cancelled claims. Claims 1-9, 10-18, 19-20 are pending. Claims 1-9, 19-20 will be examined on the merits herein.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-9, 19-20) in reply filed on June 3, 2026 is acknowledged. Claims 10-18 are withdrawn from further consideration pursuant to 37 CFR 1.142 (b) as being drawn to nonelected invention, there being no allowance generic or linking claim.
Priority
Acknowledgement is made of applicant’s claim for foreign priority based on an application filed on July 26, 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement (IDS)
The IDS submission is in compliance with the provisions of 37 CFR 1.97.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 6-9, 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gulla et al. (Pat. US 11180561 B2; hereafter Gulla; PTO-892).
As claims 1-2, 6, 19-20, Gulla teaches “the discovery and characterization of antibodies that bind the extracellular domain (ECD) of KLRG1 but do not interfere with its interaction with the ligands E-cadherin, N-cadherin, and R-cadherin. The antibodies described have been derived by mouse hybridoma technology, and can be humanized by grafting their complementary determining regions (CDRs) into a human framework. The antibodies described can be used as effective therapeutic agents. Various antibodies, or antigen-binding fragments of such antibodies, along with various therapeutic and/or diagnostic methods, among other features”. See abstract.
Gulla teaches humanized constructs, humanization was carried out by grafting the CDR of the mouse antibodies onto human framework sequences with the highest sequence homology. See Table 5, 8.
Gulla teaches “an antibody, or fragment thereof, that specifically binds to an extracellular domain of KLRG1, and which comprises a heavy chain variable region comprising three heavy chain complementarity determining regions (CDR-H1, CDR-H2 and CDR-H3) and a light chain variable region comprising three light chain complementary determining regions (CDR-L1, CDR-L2 and CDR-L3), wherein said antibody, or fragment thereof comprises: … SEQ ID NO:20 (CDR-L2), … SEQ ID NO:32 (CDR-L2)… SEQ ID NO:38 (CDR-L2), … SEQ ID NO:33 (CDR-L3)”. See claim 1.
Gulla teaches “The antibody, or fragment thereof, of claim 1, comprising …or h) the three heavy chain complementarity determining regions and the three light chain complementarity determining regions of iii); wherein the heavy chain variable region comprises SEQ ID NO:54 or a sequence at least 90% identical to SEQ ID NO:54; and the light chain variable region comprises SEQ ID NO:55 or a sequence at least 90% identical to SEQ ID NO:55. See claims 2, 8.
Gulla teaches SEQ ID NO: 54, ABC_HG1D03-VH. SEQ ID NO: 54 is 99.5% identical to SEQ ID NO: 4. See Table 5, and Figure below.
Gulla teaches SEQ ID NO: 31 (CDR-L1), SEQ ID NOs: 20, 32, 38 (CDR-L2) and SEQ ID NO: 33 (CDR-L3), ABC_G1D03, mouse antibodies. See Table 3. Gulla also teaches SEQ ID NO: 55 (ABC_HG1D03-VK), mouse grafted antibodies, humanized antibodies. SEQ ID NO:55 comprises the amino acid sequence of SEQ ID NO: 11 (CDR-L1), SEQ ID NO:12 (CDR-L2), and SEQ ID NO:13 (CDR-L3). See Table 3, 5, claims 1; and Figures below.
Gulla teaches SEQ ID NO: 55 is 97.5% identical to SEQ ID NO: 5. See claims 2,8; Table 5; and Figure below.
Gulla teaches “the antibody, or a fragment thereof, can comprise a monoclonal antibody, or a fragment thereof”. “The monoclonal antibody, or a fragment thereof, can specifically bind the epitope PLNFSRI (SEQ ID NO:56), or a fragment thereof, comprising at least five (5) contiguous amino acids. SEQ ID NO: 56 is 100% identical to SEQ ID NO: 14. See column 3; lines 52-55. “Peptide mapping of binding epitope of ABC_G1D03, showing binding of the antibody to a peptide sequence defined by the amino acids “PLNFSRI” (SEQ ID NO:56)”. See Figures 2, 3.
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As claims 7-8, Gulla teaches “the antibody, or a fragment thereof, comprises a monoclonal antibody, or a fragment thereof, the monoclonal antibody, or a fragment thereof, can comprise a chimeric antibody, or a fragment thereof. In some embodiments in which the antibody, or a fragment thereof, comprises a monoclonal antibody, or a fragment thereof, the monoclonal antibody, or a fragment thereof, can comprise a humanized antibody or a fragment thereof”. See column 4; lines 39-47. “Binding of anti-KLRG1 monoclonal antibodies to cells that expressed human and cynomolgus-KLRG1 was carried out by FACS”. See for example, column 39; lines 65-67.
As claims 9, Gulla teaches “The KLRG1 can comprise human KLRG1 or Cyano KLRG1”. See column 3, lines 48-49. “The antibody, or a fragment of the antibody, can be such that the KLRG1 comprises human KLRG1 or Cyano KLRG1”. See column 6; lines 29-31.
As claims 19-20, Gulla teaches “a pharmaceutical composition comprises one or more of an antibody, or fragment of the antibody, a monoclonal antibody, or a fragment of the antibody, or derivative of either such antibody or fragment and a pharmaceutically acceptable carrier”. See column 7, lines 38-46.
Gulla teaches “a kit comprises one or more of an antibody, or fragment of the antibody, a monoclonal antibody, or a fragment of the antibody, or derivative of either such antibody or fragment, and instructions for use”. See column 7, lines 47-54.
Claims 3-5 are rejected because they are dependent of claim 1.
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.
Claims 1-2, 6-9, 19-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-13, 16-23 of U.S. Patent No. 11180561 B2.
‘561 discloses an antibody, or fragment thereof, that specifically binds to an extracellular domain of KLRG1, and which comprises SEQ ID NO:28 (CDR-H1), SEQ ID NO:29 (CDR-H2), SEQ ID NO:30 (CDR-H3), SEQ ID NO:32 (CDR-L2), and SEQ ID NO:33 (CDR-L3), SEQ ID NO:36 (CDR-H3), SEQ ID NO:31 (CRD-L1), SEQ ID NO:38 (CDR-L2), SEQ ID NO:20 (CDR-L2). See ‘561, claim 1; See Table 3 for sequences. See below Alignments for Sequence Similarities and Identity.
‘561 discloses a sequence at least 90% identical to SEQ ID NO:54; and the light chain variable region comprises SEQ ID NO:55 or a sequence at least 90% identical to SEQ ID NO:55.” See ‘561, claim 2.
‘561 discloses “the antibody, or fragment thereof, is a monoclonal antibody, or fragment thereof”. See ‘561, claim 3.
‘561 discloses the antibody, or fragment, thereof is a humanized antibody, or fragment thereof.” See ‘561, claim 7. See Alignments for Sequence Similarities and Identity.
‘561 discloses the antibody, or fragment thereof, of claim 3, comprising […] the three heavy chain complementarity determining regions and the three light chain complementarity determining regions of iii); wherein the heavy chain variable region comprises SEQ ID NO:54 or a sequence at least 95% identical to SEQ ID NO:54; and the light chain variable region comprises SEQ ID NO:55 or a sequence at least 95% identical to SEQ ID NO:55”. See ‘561, claim 8. See Alignments for Sequence Similarities and Identity.
‘561 discloses an antibody, or fragment thereof, that specifically binds to an extracellular domain of KLRG1, and which comprises a heavy chain comprising three heavy chain complementarity determining regions comprising SEQ ID NO:28 (CDR-H1), SEQ ID NO:29 (CDR-H2), and SEQ ID NO:30 (CDR-H3) and a light chain comprising three light chain complementary determining regions comprising SEQ ID NO:31 (CRD-L1), SEQ ID NO:32 (CDR-L2), and SEQ ID NO:33 (CDR-L3)”. See ‘561, claim 9. See Table 3 for Sequences. See Alignments for Sequence Similarities and Identity.
‘561 discloses claims the antibody, or fragment thereof, of claim 9, wherein said light chain comprises a light chain variable region comprising SEQ ID NO:55 or a sequence at least 90% identical to SEQ ID NO:55”. See ‘561, claim 10 and Table 3 for sequences. See Alignments for Sequence Similarities and Identity.
‘561 discloses the antibody, or fragment thereof, of claim 10, wherein said light chain variable region comprises SEQ ID NO:55 or a sequence at least 95% identical to SEQ ID NO:55”. See ‘561, claim 11.
‘561 discloses the antibody, or fragment thereof, of claim 9, wherein said light chain comprises a heavy chain variable region comprising SEQ ID NO:54 or a sequence at least 90% identical to SEQ ID NO:54. See ‘561, claim 12 and Table 3 for Sequences. See Alignments for Sequence Similarities and Identity.
‘561 discloses the antibody or fragment thereof of claim 12, wherein said heavy chain variable region comprises SEQ ID NO:54 or a sequence at least 95% identical to SEQ ID NO:54”. See ‘561, claim 13, and Table 3 for Sequences. See Alignments for Sequence Similarities and Identity.
‘561 discloses “An antibody, or fragment thereof, that specifically binds to an extracellular domain of KLRG1, and which comprises (a) a heavy chain comprising heavy chain complementarity determining regions comprising SEQ ID NO:28 (CDR-H1), SEQ ID NO:29 (CDR-H2), and SEQ ID NO:30 (CDR-H3); (b) a light chain comprising three light chain complementary determining regions comprising SEQ ID NO:31 (CRD-L1), SEQ ID NO:32 (CDR-L2), and SEQ ID NO:33 (CDR-L3); (c) wherein said heavy chain comprises a heavy chain variable region comprising SEQ ID NO:54 or a sequence at least 90% identical to SEQ ID NO:54; and (d) wherein said light chain comprises a light chain variable region comprising SEQ ID NO:55 or a sequence at least 90% identical to SEQ ID NO:55. See ‘561, claim 16 and Table 3 for sequences. See Alignments for Sequence Similarities and Identity.
‘561 discloses an extracellular domain of KLRG1, and which comprises (a) a heavy chain comprising heavy chain complementarity determining regions comprising SEQ ID NO:28 (CDR-H1), SEQ ID NO:29 (CDR-H2), and SEQ ID NO:30 (CDR-H3); (b) a light chain comprising three light chain complementary determining regions comprising SEQ ID NO:31 (CRD-L1), SEQ ID NO:32 (CDR-L2), and SEQ ID NO:33 (CDR-L3); (c) wherein said heavy chain comprises a heavy chain variable region comprising SEQ ID NO:54 or a sequence at least 90% identical to SEQ ID NO:54; and (d) wherein said light chain comprises a light chain variable region comprising SEQ ID NO:55 or a sequence at least 90% identical to SEQ ID NO:55. See ‘561, claim 16 and Table 3 for Sequences.
‘561 discloses the antibody or fragment thereof of claim 16, wherein said heavy chain variable region comprises SEQ ID NO:54 or a sequence at least 95% identical to SEQ ID NO:54; and said light chain variable region comprises SEQ ID NO:55 or a sequence at least 95% identical to SEQ ID NO:55. See ‘561, claim 17 and Table 3 for sequences. See Alignments for Sequence Similarities and Identity.
‘561 discloses “A pharmaceutical composition, comprising the antibody, or fragment thereof, and a pharmaceutically acceptable carrier. See ‘561, claims 18-20.
‘561 discloses “A kit, comprising the antibody, or fragment thereof and packaging materials therefore.” See ‘561, claims 21-23.
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Although the claims at issue are not identical, they are not patentably distinct from each other because the antibodies of SEQ ID NOs: 4, 11-13 (claim 1) and SEQ ID NOs: 5, 11-13 (claim 2) are the same antibodies of US 11180561 B2 (claims 1-3, 7-13, 16-17). The CDRs of SEQ ID NOs: 31-21 of US 11180561 B2 are 100% identical to SEQ ID NOs: 11-13 (claim 1-2) and SEQ ID NOs: 4-5 are at least 90 and/or 95% identical to SEQ ID NOs: 54-55 of US 11180561 B2.
Claims 19-23 drawn to a pharmaceutical composition, comprising at least one antibody, or fragment thereof, and a pharmaceutically acceptable carrier, and a kit, comprising at least one antibody, or fragment thereof, as claims 18-20 of US 11180561 B2.
Therefore, claims 1-2, 6-9, 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-13, 16-23 of U.S. Patent No. 11180561 B2.
Allowable Subject Matter
SEQ ID NOs: 6-7 were searched and are free of prior art. However, claims 3-5 are dependent of claim 1.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PRICILA HAUK TEODORO whose telephone number is (571) 272-2784. The examiner can normally be reached M-F 6:15AM-3:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at (571) 272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PRICILA NMN HAUK TEODORO/Examiner, Art Unit 1645
/HEATHER CALAMITA/ Supervisory Patent Examiner, Art Unit 1684
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