Prosecution Insights
Last updated: April 19, 2026
Application No. 18/367,252

ANTIBODIES AGAINST GLUCOCORTICOID-INDUCED TUMOR NECROSIS FACTOR RECEPTOR (GITR) AND USES THEREOF

Non-Final OA §DP
Filed
Sep 12, 2023
Examiner
SUNSHINE, HANNAH LOUISE
Art Unit
1647
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Bristol-Myers Squibb Company
OA Round
1 (Non-Final)
71%
Grant Probability
Favorable
1-2
OA Rounds
4y 0m
To Grant
86%
With Interview

Examiner Intelligence

Grants 71% — above average
71%
Career Allow Rate
17 granted / 24 resolved
+10.8% vs TC avg
Strong +16% interview lift
Without
With
+15.7%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
39 currently pending
Career history
63
Total Applications
across all art units

Statute-Specific Performance

§101
3.5%
-36.5% vs TC avg
§103
29.2%
-10.8% vs TC avg
§102
14.0%
-26.0% vs TC avg
§112
28.7%
-11.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 24 resolved cases

Office Action

§DP
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 . Priority The instant application, filed 09/12/2023, is a divisional of US application 16/663,583, filed 10/25/2019, which is a divisional of US application 15/369,290, filed 12/05/2016, which is a continuation of International Application No. PCT/US2015/033991, filed 06/03/2015, which claims domestic benefit to US provision applications 62/082,980 and 62/008,945, filed 11/21/2014 and 06/06/2014, respectively. Claim Status The Amendment, filed on 01/31/2024, is acknowledged in which: Claims 1-68 are canceled. Claims 69-88 are new. Claims 69-88 are pending in the instant application and are examined on the merits herein. Information Disclosure Statement The information disclosure statements filed 02/06/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. While according to MPEP 609.02, copies need not be resubmitted in the divisional application (i.e. instant application), copies must be present in parent application(s). The following references have been placed in the application file, but the information referred to therein has not been considered: JP 201391644 (FOR Ref No. 7 (9 pg IDS)) WO 2016/196792 (FOR Ref No. 10 (9 pg IDS)) WO 2012/016227 (FOR Ref No. 13 (9 pg IDS)) WO 2015/187835 (FOR Ref No. 15 (9 pg IDS)) WO 2015/145360 (FOR Ref No. 16 (9 pg IDS)) EP 0920505 (FOR Ref No. 1 (17 pg IDS) only cover page provided in parent) Kuenen et al. (NPL Ref No. 43 (17 pg IDS) All other references, where not lined through, have been considered. Nucleotide and/or Amino Acid Sequence Disclosures REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES Items 1) and 2) provide general guidance related to requirements for sequence disclosures. 37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted: In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying: the name of the ASCII text file; ii) the date of creation; and iii) the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying: the name of the ASCII text file; the date of creation; and the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended). When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical. Specific deficiencies and the required response to this Office Action are as follows: Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings Figures 37, 38C, 38D, 38E, 39A, 39B, and 39C are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings. Required response – Applicant must provide: Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers; AND/OR A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of: A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version); A copy of the amended specification without markings (clean version); and A statement that the substitute specification contains no new matter. Specification The use of the term “Biacore” (pg 3, line 2; pg 48, line 1; pg 50, line 18; pg 35, second to last line; pg 52, line 8; pg 59, line 22; pg 72, line 15; pg 74, line 13; pg 78, line 15; pg 80, ¶ 3, line 13; pg 95, line 1; pg 101, line 11; No 8, line 3; pg 179, ¶ 3, line 1; pg 180, ¶ 2, line 1 and ¶ 3, line 1; pg 184, ¶ 4, line 12), “Ficoll” (pg 81, ¶ 2, line 4; pg 189, last line; pg 205, last ¶, line 2), “BD FACS Calibur” (pg 81, ¶ 2, line 19) “FlowJo” (pg 81, ¶ 2, line 20; pg 183, lines 10 and 23; pg 184, line 3; pg 205, ¶ 2, last line), “Sepharose” (pg 110, ¶ 2, line 3; pg 117, ¶ 2, line 3), “BD FACS Canto” (pg 179, line 6; pg 182, ¶ 4, line 7; pg 183, line 9 and ¶ 2, line 12; pg 184, line 2), “RosetteSep” (pg 190, line 3), “MyeloCult” (pg 202, ¶ 4, line 6), “gentleMACS” (pg 205, ¶ 2, line 3), “LSRFortessa” (pg 205, ¶ 2, line 5), “BD OptEIA” (pg 206, line 8), which are trade names or marks used in commerce, have been noted in this application. Each term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (pg 38, last line; pg 39, line 8). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. 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. US 9,228,016 B2 Claims 69-76, 79, and 83-84 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5 of U.S. Patent No. 9,228,016 (herein US’016). Although the claims at issue are not identical, they are not patentably distinct from each other. Regarding claims 69-71, 73 and 84, Claims 1, 4, and 5 of US’016 claim an isolated monoclonal antibody species which binds to human (i.e. requires human or humanized antibody) anti-GITR with identical sequences to instant species (a) of instant claims 69 and 70, and species (a)-(c) of instant claim 71 (CDRs, VH/VL, and HC/LC, respectively). While the instant claims are broadly drawn to an antibody, the instant specification defines “antibody” to include monoclonal antibodies (instant specification, pg 26, ¶ 1). As the claims of US’016 recite an anti-GITR monoclonal antibody within scope of the instant claims, they are patentably indistinct. See In re Goodman, 11 F.3d 1046, 1052, 29 USPQ2d 2010, 2015-16 (Fed. Cir. 1993). Moreover, as the instant specification discloses that GITR expression is induced on effector T cells (i.e. activated T cells) it would be inherent that a human anti-GITR antibody as recited in conflicting US’016 claim 1 would inherently bind to human GITR on activated human T cells as recited in instant claim 73. Furthermore, regarding claim 84, the kit (i.e. additional printed matter not functionally related to the product) as claimed does not structurally provide more to the invention which is anticipated by the conflicting patent (See MPEP 2112.01(III)). Regarding claim 72, claim 3 of US’016 further recites a KD of 10nM or less. Regarding claim 74, claim 2 of US’016 further claims the antibody stimulates a T cell response. Regarding claims 75 and 76, claim 18 of US’016 further claims the antibody is an IgG1, IgG2, or IgG4 isotypes (i.e. species that anticipate the genus of instant claim 75). Regarding claim 79, claim 6 of US’016 further claims nucleic acids encoding the heavy and/or light chain variable regions of the antibody of claim 1 (patentably indistinct from instant claim 69 discussed above). Regarding claim 83, claim 7 of US’016 further claims a composition of the antibody of claim 1 (patentably indistinct from instant claim 69 discussed above) and a carrier. US 9,745,379 B2 Claims 69-73, 75-77, 79, and 83-84 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-16, 19-20, 23-24, 27-58 of U.S. Patent No. 9,745,379 (herein US’397). Although the claims at issue are not identical, they are not patentably distinct from each other. Regarding claims 69-71 and 84, Claims 1, 8, 11-14, and 27-42 of US’397 claim an isolated antibody with identical CDRs and VH/VL sequences as recited in instant claims 69 and 70 (species (a)), respectively, and identical heavy and light chain sequences as recited in instant claim 71 (species (a)-(c)) (In re Goodman). Furthermore, regarding claim 84, the kit (i.e. additional printed matter not functionally related to the product) as claimed does not structurally provide more to the invention which is anticipated by the conflicting patent (See MPEP 2112.01(III)). Regarding claim 72, claims 2-3 of US’397 further claims the antibody binds to a cell expressing membrane-bound human GITR with a KD of “10nM or less” or “1nM or less,” respectively, both within scope of the instant claim. Regarding claim 73, claim 4 of US’397 claims the antibody binds to GITR on activated human T cells. Regarding claims 75 and 77, claim 6 and 9 of US’397 claims the antibodies of claim 1 and 8, respectively, as a human IgG antibody. Regarding claim 76, claims 7 and 10 of US’397 further claim the antibodies of claims 1 and 8, respectively, are IgG1, IgG2 or IgG4 antibodies. Regarding claim 79, claims 15, 19, and 23 of US’397 claims a nucleic acid encoding the heavy and/or light chain variable region of the antibody of claim 1 (i.e. CDRs identical to instant claim 69 discussed above) or sequences comprising the CDRs of claim 1 (discussed above). Regarding claim 83, claims 16, 20, 24, and 43-58 of US’397 claims a composition comprising the antibody of claim 1 (i.e. CDRs identical to instant claim 69 discussed above) or sequences comprising the CDRs of claim 1, and a pharmaceutically acceptable carrier. US 10,501,550 B2 Claims 86 and 87 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 40 of U.S. Patent No. 10,501,550 (herein US’550). Although the claims at issue are not identical, they are not patentably distinct from each other. Regarding claims 69 and 86, claim 1 of US’550 claims a method for inhibiting the growth of a tumor comprising administering the subject an effective amount of an antibody which binds to human GITR wherein the CDRs are identical to instant species (a) from instant claim 69. Regarding claims 69 and 87, claim 40 of US’550 claims a method for treating cancer comprising administering the subject an effective amount of an antibody which binds to human GITR wherein the CDRs are identical to instant species (a) from instant claim 69. US 10,465,010 B2 Claims 69-71, 79 and 83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-9, and 12 of U.S. Patent No. 10,465,010 (herein US’010). Although the claims at issue are not identical, they are not patentably distinct from each other. Regarding claims 69-71, Claims 1-4 of US’010 claim an isolated antibody which binds to human GITR with heavy and light chain sequences identical to species recited in claim 71 (species (b)-(c)), which comprise identical CDRs and VH/VL sequences as recited in instant claims 69 and 70 (species (a)). Regarding claim 79, claims 7 and 8 of US’010 claim nucleic acids of the isolated antibodies of claims 1 and 2, respectively, which encode sequences comprising the CDRs recited in instant claim 69 (species (a)). Regarding claim 83, claims 9 and 12 of US’010 claim compositions of the isolated antibodies of claims 1 and 2, respectively, which encode sequences comprising the CDRs recited in instant claim 69 (species (a)). US 10,690,674 B2 Claims 69-70, 73, 75-77, 82, 84, and 88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 12-14, 19-21, 24, and 27 of U.S. Patent No. 10,690,674 (herein US’674). Although the claims at issue are not identical, they are not patentably distinct from each other. Regarding claims 69, 73, and 88, claim 1 of US’674 claims a method of determining the level of GITR on tumor infiltrating lymphocytes (i.e. activated T cells) tissue sample, comprising (a) contacting the sample with an antibody comprising CDRs identical to instant claim 69 species (m), wherein the antibody binds to human GITR, and (b) detecting the binding of the antibody to GITR (i.e. detecting complex formation). Claim 2 of US’674 also claims a method of detecting human GITR in a biological sample comprising (a) contacting the sample with an antibody identical to instant claim 69 species (m), and (b) detecting the binding of the antibody to GITR in the sample (i.e. detecting complex formation). Claim 3 and 4 teach the methods of claim 1 and 3, respectively, where in the sample is human. Regarding claims 69 and 84, claim 20 of US’674 claims a kit comprising an antibody comprising CDRs identical to those recited in instant claim 69 (species (m)), and instructions for use. Regarding claim 70, claim 12 (dependent on claim 1), claim 21 (dependent on claim 2), and claim 24 (dependent on claim 20) of US’674 claim the respective patentably indistinct antibody comprises VH/VL sequences identical to the instant claim (species (m)). Regarding claims 75-77, claims 13-14 (dependent on claim 1) of US’674 claim the antibody is an IgG1, IgG2, IgG3, or IgG4 antibody, and is humanized, human or chimeric. Regarding claim 82, claim 19 (dependent on claim 2) and claim 27 (dependent on claim 20) of US’674 claims the antibody comprises a detectable moiety (i.e. immunoconjugate, linked to a detectable agent) US 11,213,586 B2 Claims 69-70, 73-84, and 88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-12 of U.S. Patent No. 11,213,586 (herein US’586). Although the claims at issue are not identical, they are not patentably distinct from each other. Regarding claims 69 and 75-76, claim 1 of US’586 claims an antibody that binds to GITR comprising identical CDRs to instant species (a) and has a heavy chain constant region comprising sequence encoding a modified human IgG2 within scope of instant claims 75-76. Regarding claim 70, claim 2 of US’586 claims VH/VL sequences identical to instant species (a). Regarding claim 74, claim 12 (dependent on claim 1) of US’586 claims a method of stimulating a T-cell response using the antibody of claim 1 such that a T cell response is stimulated (i.e. the antibody is inherently able to stimulate a T cell response). Regarding claim 77, claim 4 (dependent on claim 1) of US’586 claims the antibody is a human or humanized antibody. Regarding claim 78, claim 5 (dependent on claim 1) of US’586 claims a bispecific molecule comprising the antibody of claim 1 linked to a molecule having a second binding affinity. Regarding claim 79, claim 6 (dependent on claim 1) of US’586 claims a nucleic acid encoding a VH/VL of the antibody of claim 1. Regarding claim 80, claim 7 (dependent on claim 6) of US’586 claims an expression vector Regarding claim 81, claim 8 (dependent on claim 7) of US’586 claims a cell transformed with the expression vector. Regarding claim 82, claim 9 (dependent on claim 1) of US’586 claims an immunoconjugate. Regarding claim 83, claim 10 (dependent on claim 1) of US’586 claims a composition with a carrier. Regarding claim 84, claim 11 (dependent on claim 1) of US’586 claims a kit. US 11,084,881 B2 Claims 69-71 and 73-85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,084,881 (herein US’881). Although the claims at issue are not identical, they are not patentably distinct from each other. Regarding claim 69, claim 1 of US’881 claims an antibody that binds to GITR comprising identical CDRs to instant species (b). Regarding claim 70, claim 2 of US’881 claims an anti-GITR antibody with VH/VL sequences identical to instant species (b). Regarding claim 71, claim 3 of US’881 claims an anti-GITR antibody with HC/LC sequences identical to instant species (d)-(e). Regarding claim 73, claim 5 (dependent on claim 1) of US’881 claims the antibody binds to human GITR on activated human T cells. Regarding claim 74, claim 6 (dependent on claim 1) of US’881 claims the antibody stimulates a T cell response. Regarding claim 75, claim 7 (dependent on claim 1) of US’881 claims the antibody is a human IgG antibody. Regarding claim 76, claim 8 (dependent on claim 7) of US’881 claims the antibody is an IgG1, IgG2, IgG3, or IgG4 antibody. Regarding claim 77, claim 9 (dependent on claim 1) of US’586 claims the antibody is a human or humanized antibody. Regarding claim 78, claim 10 (dependent on claim 1) of US’586 claims a bispecific molecule comprising the antibody of claim 1 linked to a molecule having a second binding affinity. Regarding claim 79, claim 11 (dependent on claim 1) of US’586 claims a nucleic acid encoding a VH/VL of the antibody of claim 1. Regarding claim 80, claim 12 (dependent on claim 11) of US’586 claims an expression vector Regarding claim 81, claim 13 (dependent on claim 12) of US’586 claims a cell transformed with the expression vector. Regarding claim 82, claim 14 (dependent on claim 1) of US’586 claims an immunoconjugate. Regarding claim 83, claim 15 (dependent on claim 1) of US’586 claims a composition with a carrier. Regarding claim 84, claim 16 (dependent on claim 1) of US’586 claims a kit. Regarding claim 85, claim 17 of US’586 claims a method of preparing antibody which binds to human GITR comprising culturing the cell of claim 13 (patentably indistinct from claim 81 as discussed above) and isolating the antibody from the cell. US 11,685,787 B2 Claims 69, 70, and 75 and 87 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 12-13 of U.S. Patent No. 11,685,787 (herein US’787). Although the claims at issue are not identical, they are not patentably distinct from each other. Regarding claims 69 and 87, the instant claim inclusive or open-ended language to define the scope of the claim. Specifically, the term “comprising” is inclusive and does not exclude additional, unrecited elements or method steps (see MPEP 2111.03). Therefore, additional elements as recited in conflicting claim 2 of US’787 can recite additional elements and remain in scope of the generic instant claim as additional limitations are not excluded. Therefore, claim 2 of U’787 claiming a method of treating a human subject having cancer comprising administering an antibody species within scope of instant claim 69 (identical to instant species (a)) is further patentably indistinct from instant claim 87. Regarding claim 70, claim 12 (dependent on claim 2) of US’787 claims identical VH/VL sequences to instant species (a). Regarding claim 75, claim 13 (dependent on claim 12) of US’787 claims the antibody comprises an IgG heavy chain (inherently human based on the method as designed for humans as recited in claim 2). US 11,408,889 B2 Claims 69-70, 73, 79-81 and 88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,408,889 (herein US’889). Although the claims at issue are not identical, they are not patentably distinct from each other. Regarding claims 69, claim 1 of US’889 claims an antibody with CDRs identical to instant species (m). Regarding claim 70, claim 4 (dependent on claim 1) of US’889 claims identical VH/VL sequences to instant species (m). Regarding claims 73 and 88, claim 16 of US’889 claims a method of determining the level of GITR on tumor infiltrating lymphocytes (i.e. activated T cells) from a human tissue sample, comprising (a) contacting the sample with an antibody comprising CDRs identical to instant claim 69 species (m), and (b) detecting the binding of the antibody to GITR (i.e. detecting complex formation). Regarding claim 79, claim 8 (dependent on claim 1) of US’586 claims a nucleic acid encoding a VH/VL of the antibody of claim 1. Regarding claim 80, claim 9 (dependent on claim 8) of US’586 claims an expression vector Regarding claim 81, claim 10 (dependent on claim 9) of US’586 claims a cell transformed with the expression vector. Regarding claim 82, claim 5 (dependent on claim 1) of US’889 claims the antibody comprises a detectably moiety (i.e. immunoconjugate). Conclusion No claims are currently allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNAH SUNSHINE whose telephone number is (571)270-7417. The examiner can normally be reached M-Th & Second Friday 8:30am-5pm EST. 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, Joanne Hama can be reached at (571) 272-2911. 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. /HANNAH SUNSHINE/Examiner, Art Unit 1647 /JOANNE HAMA/, Supervisory Patent Examiner, Art Unit 1647
Read full office action

Prosecution Timeline

Sep 12, 2023
Application Filed
Mar 23, 2026
Non-Final Rejection — §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
71%
Grant Probability
86%
With Interview (+15.7%)
4y 0m
Median Time to Grant
Low
PTA Risk
Based on 24 resolved cases by this examiner. Grant probability derived from career allow rate.

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