Prosecution Insights
Last updated: May 04, 2026
Application No. 17/913,429

DEVELOPMENT AND APPLICATION OF IMMUNE CELL ACTIVATOR

Final Rejection §102§103§DP
Filed
Sep 21, 2022
Priority
Mar 23, 2020 — CN 202010208900.0 +1 more
Examiner
HOLTZMAN, KATHERINE ANN
Art Unit
1646
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
BIO-THERA SOLUTIONS, LTD.
OA Round
2 (Final)
63%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allowance Rate
38 granted / 60 resolved
+3.3% vs TC avg
Strong +61% interview lift
Without
With
+61.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
29 currently pending
Career history
89
Total Applications
across all art units

Statute-Specific Performance

§101
5.5%
-34.5% vs TC avg
§103
27.0%
-13.0% vs TC avg
§102
11.8%
-28.2% vs TC avg
§112
28.7%
-11.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 60 resolved cases

Office Action

§102 §103 §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 . Election/Restrictions Applicant’s election without traverse of the species antibody comprising the CDRs set forth in SEQ ID NOs: 10, 26, 27, 61, 25, and 34 in the reply filed on September 5, 2025 is acknowledged. All claims read on the elected species – all claims are examined herein. Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, CN 202010208900.00 is not a certified English translation. Therefore, the claims are examined with the filing date of PCT/CN 2021/081993, March 2, 2021. Claim Objections Claims 3(i), 4, 5, 6, 7, and 18 are objected to because of the following informalities: the claims recite an antibody region, for example a CDR, “comprising in” a SEQ ID NO. This appears to be a typographical error. Examiner suggests deleting the word “in” from between “comprising” and “SEQ ID NO”. Appropriate correction is required. 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. (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. Claims 3-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Liang et al. (US 2023/0416386 A1; Effectively Filed: November 19, 2020; Published: December 28, 2023) as evidenced by the instant Specification. Regarding claim 3, Liang et al. teaches an OX40 antibody comprising the CDRs of SEQ ID NOs: 1-6 which are 100% identical to instant SEQ ID NOs: 10, 26, 27, 61, 25, and 34, respectively; see claim 1. Regarding claims 4 and 5, Liang et al. teaches the antibody comprising the VH and VL of SEQ ID NOs: 7 and 8 which are 100% to instant SEQ ID NOs: 72 and 84 respectively; see claim 2. Regarding claims 6, 7, and 18, Liang et al. teaches the antibody comprising the heavy and light chains of SEQ ID NOs: 9 and 10 which are 100% to instant SEQ ID NOs: 86 and 87, respectively, and comprise instant SEQ ID NOs: 90 and 91; see claim 2. Regarding claim 8, the antibody taught by Liang et al. comprises identical VH and VL regions to that of “Antibody M” and the instant Specification evidences that a KD of less than or equal to 5nM is an inherent property of “Antibody M” ; see Tables 3 and 11. Regarding claims 9-11, 19, and 20, Liang et al. teaches that the antibody has a fucosylation level or fucose content of 0-10% or is expressed in a CHO cell having a Fut8, or alpha-(1,6))-fucosyltransferase gene knock out; see claims 4-5 and paragraph 0017. Regarding claims 12 and 13, Liang et al. teaches a polynucleotide sequence encoding the antibody and a cell comprising one or more polynucleotides encoding the antibody; see Example 1 and Table 2. Regarding claim 14, Liang et al. teaches the antibody as a pharmaceutical composition; see paragraph 0048. Regarding claims 15 and 16, Liang et al. teaches administering the antibody to treat cancer; see claims 1 and 6. Regarding claim 17, Liang et al. teaches that the antibody may be combined with a second therapeutic agent for the treatment of cancer; see paragraph 0045. Thus, Liang et al. (US 2023/0416386 A1) anticipates instant claims 1-20. Claims 3-8 and 12-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Huang et al. (WO 2021/238932 A1; Effectively Filed: May 26, 2020; Published: December 2, 2021) as evidenced by the instant Specification. Regarding claim 3, Huang et al. teaches an OX40 antibody comprising the heavy and light chains of SEQ ID NOs: 73 and 74; see page 38 of the Chinese document. SEQ ID NO: 73 comprises instant SEQ ID NOs: 10, 26, and 27 at residues 31-35, 50-66, and 99-111, respectively. SEQ ID NO: 74 comprises instant SEQ ID NOs: 61, 25, and 34 at residues 24-34, 50-56, and 89-97, respectively. Regarding claims 4 and 5, the OX40 antibody comprising the heavy and light chains of SEQ ID NOs: 73 and 74 comprises the VH and VL of instant SEQ ID NOs: 72 and 84 at residues 1-122 and 1-107, respectively. Regarding claims 6, 7, and 18, the OX40 antibody comprising the heavy and light chains of SEQ ID NOs: 73 and 74 comprises the heavy and light constant regions of instant SEQ ID NOs: 90 and 91 at residues 123-422 and 108-214, respectively. Regarding claim 8, the antibody taught by Huang et al. comprises identical VH and VL regions to that of “Antibody M” and the instant Specification evidences that a KD of less than or equal to 5nM is an inherent property of “Antibody M” ; see Tables 3 and 11. Regarding claims 12 and 13, Huang et al. teaches a polynucleotide sequence encoding the antibody and a cell comprising one or more polynucleotides encoding the antibody; see Example 6. Regarding claim 14, Huang et al. teaches the antibody as a pharmaceutical composition; see page 22 of the English translation. Regarding claims 15 and 16, Huang et al. teaches administering the antibody to treat cancer; see pages 22 and 23. Regarding claim 17, Huang et al. teaches that the antibody may be combined with a second therapeutic agent for the treatment of cancer; see pages 46-47 of the English translation. Thus, Huang et al. (WO 2021/238932 A1) anticipates instant claims 1-8 and 12-18. Claims 3-8 and 12-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Liang et al. (WO 2022/007807 A1; Effectively Filed: July 7, 2020; Published: January 13, 2022) as evidenced by the instant Specification. Regarding claim 3, Liang et al. teaches an OX40 antibody comprising the heavy and light chains of SEQ ID NOs: 53 and 54; see pages 36-37 of the Chinese document. SEQ ID NO: 53 comprises instant SEQ ID NOs: 10, 26, and 27 at residues 31-35, 50-66, and 99-111, respectively. SEQ ID NO: 54 comprises instant SEQ ID NOs: 61, 25, and 34 at residues 24-34, 50-56, and 89-97, respectively. Regarding claims 4 and 5, the OX40 antibody comprising the heavy and light chains of SEQ ID NOs: 53 and 54 comprises the VH and VL of instant SEQ ID NOs: 72 and 84 at residues 1-122 and 1-107, respectively. Regarding claims 6, 7, and 18, the OX40 antibody comprising the heavy and light chains of SEQ ID NOs: 53 and 54 comprises the heavy and light constant regions of instant SEQ ID NOs: 90 and 91 at residues 123-422 and 108-214, respectively. Regarding claim 8, the antibody taught by Liang et al. comprises identical VH and VL regions to that of “Antibody M” and the instant Specification evidences that a KD of less than or equal to 5nM is an inherent property of “Antibody M”; see Tables 3 and 11. Regarding claims 12 and 13, Liang et al. teaches a polynucleotide sequence encoding the antibody and a cell comprising one or more polynucleotides encoding the antibody; see Example 6. Regarding claim 14, Liang et al. teaches the antibody as a pharmaceutical composition; see page 21 of the English translation. Regarding claims 15 and 16, Liang et al. teaches administering the antibody to treat cancer; see pages 22 and 23. Regarding claim 17, Liang et al. teaches that the antibody may be combined with a second therapeutic agent for the treatment of cancer; see pages 45-46 of the English translation. Thus, Liang et al. (WO 2022/007807 A1) anticipates instant claims 1-8 and 12-18. 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 9-11, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (WO 2021/238932 A1; Effectively Filed: May 26, 2020; Published: December 2, 2021) in view of Cai et al. (US 2016/0347849 A1; Published: December 1, 2016) and Harding et al. (US 2018/0171023 A1; Published: June 21, 2018). The teachings of Huang et al. as related to claims 3-8 and 12-18, from which these claims depend are given previously in this Office action and are fully incorporated here. Claims 9-11, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Liang et al. (WO 2022/007807 A1; Effectively Filed: July 7, 2020; Published: January 13, 2022) in view of Cai et al. (US 2016/0347849 A1; Published: December 1, 2016) and Harding et al. (US 2018/0171023 A1; Published: June 21, 2018). The teachings of Liang et al. as related to claims 3-8 and 12-18, from which these claims depend are given previously in this Office action and are fully incorporated here. The following analysis applies to the rejections over Huang et al. (WO 2021/238932 A1) or Liang et al. (WO 2022/007807 A1) in view of Harding et al. Huang et al. (WO 2021/238932 A1) or Liang et al. (WO 2022/007807 A1) do not teach an OX40 antibody having 0% or less than 10% fucose content or produced in a CHO cell with a Fut8 knock out. Cai et al. teaches OX40 antibodies produced in CHO cells lacking Fut8 such that the resulting antibodies are “low fucose antibodies”; see paragraph 0458. While Cai et al. teaches producing “low fucose” OX40 antibodies, the reference does not teach antibodies having 0% or 10% fucose content. Harding et al. teaches that OX40 antibodies “lacking fucose” (i.e. having 0% fucose content) have enhanced ADCC activity at low doses. Given that Harding et al. teaches that OX40 antibodies lacking fucose have enhanced ADCC activity and that Cai et al. teaches that such OX40 antibodies can be produced on CHO cell with Fut8 knocked out, it would have been obvious to one of ordinary skill in the art and one would have had a reasonable expectation of success to produce OX40 antibodies lacking fucose (i.e. 0% fucose content – which is less than 10% fucose) by expression in CHO cells deficient for Fut8. One would be motivated to make such an OX40 antibody for the enhanced ADCC activity at low doses. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the application, as evidenced by the references. 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 3-9, 11, 15, 16, 18, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6 of copending Application No. 18/037,401 (reference application) and as evidenced by the instant Specification. Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Regarding instant claim 3, copending claim 1 teaches an OX40 antibody comprising the CDRs of SEQ ID NOs: 1-6, which are 100% identical to instant SEQ ID NOs: 10, 26, 27, 61, 25, and 34, respectively. Regarding instant claims 4 and 5, copending claim 2 teaches an OX40 antibody comprising a VH and VL of SEQ ID NOs: 7 an 8 which are 100% identical to instant SEQ ID NOs: 72 and 84. Regarding instant claims 6, 7, and 18, copending claim 3 teaches an OX40 antibody comprising heavy and light chains of SEQ ID NOs: 9 and 10 which are 100% identical to instant SEQ ID NOs: 86 and 87 and comprise SEQ ID NOs: 90 and 91 at residues 123-452 and 108-214, respectively. Regarding claim 8, the antibody taught by Liang et al. comprises identical VH and VL regions to that of “Antibody M” and the instant Specification evidences that a KD of less than or equal to 5nM is an inherent property of “Antibody M”; see Tables 3 and 11. Regarding instant claims 9, 11, and 19, copending claim 4 teaches an OX40 antibody with 0-10% fucose content. Regarding instant claims 15 and 16, copending claims 1 and 6 teach a method of treating cancer comprising administering the OX40 antibody. Thus, copending claims 1-4 and 6 read on instant claims 1-9, 11, 15, 16, 18, and 19 in an anticipatory manner. Claims 10 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6 of copending Application No. 18/037,401 in view of Cai et al. (US 2016/0347849 A1; Published: December 1, 2016). This is a provisional nonstatutory double patenting rejection. The teachings of claims 1-4 and 6 of copending Application No. 18/037,401 as related to claim 3-9, 11, 15, 16, 18, and 19, from which these claims depend are given previously in this Office action and are fully incorporated here. Copending claim 5 teaches producing the OX40 antibody in a cell deficient in Fut8, but does not teach CHO cells. Cai et al. teaches OX40 antibodies produced in CHO cells lacking Fut8 such that the resulting antibodies are “low fucose antibodies”; see paragraph 0458. It would have been obvious to one of ordinary skill in the art to use CHO cell lacking Fut8 to produce the low fucose OX40 antibodies taught by the copending claims. Because Cai et al. teach OX40 cells with low fucose content resulting from expression in CHO cells lacking Fut8, one of ordinary skill in the art would have had a reasonable expectation of success making the low fucose OX40 antibody taught by the copending claims. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the application, as evidenced by the references. Claims 12-14 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6 of copending Application No. 18/037,401 in view of over Tsun et al. (WO 2018/177220 A1; Published: October 4, 2018). This is a provisional nonstatutory double patenting rejection. The teachings of claims 1-4 and 6 of copending Application No. 18/037,401 as related to claim 3-9, 11, 15, 16, 18, and 19, from which these claims depend are given previously in this Office action and are fully incorporated here. Regarding claims 12 and 13, Tsun et al. teaches a polynucleotide encoding the OX40 antibody and a cell comprising said polynucleotide; see Example 1. Regarding claim 14, Tsun et al. teaches the OX40 antibody as a composition comprising a pharmaceutically acceptable carrier; see page 40 of the English translation. Regarding claim 17, Tsun et al. teaches the OX40 antibody may be administered with a second therapeutic agent; see page 16 of the English translation. Given that Tsun et al. teaches an OX40 antibody and a method of treating cancer comprising administering the OX40 antibody, it would have been obvious to one of ordinary skill in the art to produce the OX40 antibody taught in the copending claims as a pharmaceutical composition and to administered the OX40 antibody with a second cancer therapeutic agent. Section 2144.06 of the MPEP provides guidance as to obviousness of art recognized equivalents for the same purpose. The court has held that it is obvious to combine two elements each of which is taught by the prior art to be useful for the same purpose. No specific teaching or suggestion is needed for combination – the idea of combining them flows logically from their having been individually taught in the prior art as useful for the same purpose. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Further, it would have been obvious to one of ordinary skill in the art and one would have had a reasonable expectation of success to produce a polynucleotide encoding the antibody and a cell comprising the polynucleotide in order to recombinantly produce the antibody for use in a pharmaceutical composition. One would have been motivated to make the polynucleotide encoding the antibody and a cell comprising the polynucleotide for the lower cost and speed of recombinantly producing the OX40 antibody. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the application, as evidenced by the references. Claims 3-9, 11, 14, 16, 18, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 12 of copending Application No. 19/166,027 (reference application) and as evidenced by the instant Specification. Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Regarding instant claim 3, copending claims 1-3 teach an OX40 antibody comprising the CDRs of SEQ ID NOs: 1-6, which are 100% identical to instant SEQ ID NOs: 10, 26, 27, 61, 25, and 34, respectively. Regarding instant claims 4 and 5, copending claim 4 teaches an OX40 antibody comprising a VH and VL of SEQ ID NOs: 7 an 8 which are 100% identical to instant SEQ ID NOs: 72 and 84. Regarding instant claims 6, 7, and 18, copending claim 5 teaches an OX40 antibody comprising heavy and light chains of SEQ ID NOs: 9 and 10 which are 100% identical to instant SEQ ID NOs: 86 and 87 and comprise SEQ ID NOs: 90 and 91 at residues 123-452 and 108-214, respectively. Regarding claim 8, the antibody taught by Liang et al. comprises identical VH and VL regions to that of “Antibody M” and the instant Specification evidences that a KD of less than or equal to 5nM is an inherent property of “Antibody M”; see Tables 3 and 11. Regarding instant claims 9, 11, and 19, copending claim 6 teaches an OX40 antibody with 0-10% fucose content or expressed in a cell with a Fut8 knockout. Regarding instant claim 14, copending claim 12 teaches the OX40 antibody as a pharmaceutical composition. Page 10 of the Specification teaches that “pharmaceutical composition” encompasses a composition comprising a pharmaceutically acceptable carrier. Thus, copending claims 1-6 and 12 read on instant claims 1-9, 11, 14, 16, 18, and 19 in an anticipatory manner. Claims 10, 12-13, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 12 of copending Application No. 19/166,027 in view of Cai et al. (US 2016/0347849 A1; Published: December 1, 2016). This is a provisional nonstatutory double patenting rejection. The teachings of claims 1-6 and 12 of copending Application No. 19/166,027 as related to claim 3-9, 11, 14, 16, 18, and 19, from which these claims depend are given previously in this Office action and are fully incorporated here. Copending claim 5 teaches producing the OX40 antibody in a cell deficient in Fut8, but does not teach CHO cells. Additionally, copending claim 1 teaches treating inflammatory or immune disease comprising administering the OX40 antibody, but does not specify cancer. Finally, the copending claims do not teach a polynucleotide encoding the antibody nor a cell comprising the polynucleotide. Regarding instant claims 10 and 20, Cai et al. teaches OX40 antibodies produced in CHO cells lacking Fut8 such that the resulting antibodies are “low fucose antibodies”; see paragraph 0458. Further, regarding instant claims 15-17, Cai et al. teaches a method of treating cancer comprising administering a OX40 antibody and further comprising administering a second caner therapeutic agent; see claims 22-25. Finally, regarding instant claims 12 and 13, Cai et al. teaches a nucleic acid encoding the OX40 antibody, a vector comprising the nucleic acid, and a cell comprising the vector; see claims 16-18. It would have been obvious to one of ordinary skill in the art to use CHO cell lacking Fut8 to produce the low fucose OX40 antibodies taught by the copending claims. Because Cai et al. teach OX40 cells with low fucose content resulting from expression in CHO cells lacking Fut8, one of ordinary skill in the art would have had a reasonable expectation of success making the low fucose OX40 antibody taught by the copending claims. Further, it would have been obvious to one of ordinary skill in the art and one would have had a reasonable expectation of success to produce a polynucleotide encoding the antibody and a cell comprising the polynucleotide in order to recombinantly produce the antibody for use in a pharmaceutical composition. One would have been motivated to make the polynucleotide encoding the antibody and a cell comprising the polynucleotide for the lower cost and speed of recombinantly producing the OX40 antibody. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the application, as evidenced by the references. Response to Arguments Applicant’s amendments filed January 23, 2026 are acknowledged. Any rejection not repeated above is resolved by amendment. Regarding the 35 U.S.C. 102(a)(2) and 103 rejections over Liang et al. or Huang et al., Applicant states that a certified English translation of the priority document was provided with the response dated January 23, 2026; however, no certified English translation is found. Thus, the rejections are maintained. Regarding the nonstatutory double patenting rejections over the claims of 18/037,401 or 19/166,027, indeed the instant application has an earlier patent filing date. However, the nonstatutory double patenting rejections are maintained until they are the only remaining rejections; see MPEP 1490 VI.D.2. Because rejections of record remain for the elected species, the species are not rejoined and no further search of the species recited in claims 3 and 4, beyond Applicant’s elected species comprising SEQ ID NOs: 10, 26, 27, 61, 25, and 34, are examined. Conclusion 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE ANN HOLTZMAN whose telephone number is (571)270-0252. The examiner can normally be reached Monday - Friday 7:30am - 5:00pm. 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, Janet Epps-Smith can be reached at (571)272-0757. 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. /KATHERINE ANN HOLTZMAN/Examiner, Art Unit 1646 /JULIET C SWITZER/Primary Examiner, Art Unit 1682
Read full office action

Prosecution Timeline

Sep 21, 2022
Application Filed
Oct 24, 2025
Non-Final Rejection — §102, §103, §DP
Jan 23, 2026
Response Filed
Apr 02, 2026
Final Rejection — §102, §103, §DP (current)

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Prosecution Projections

3-4
Expected OA Rounds
63%
Grant Probability
99%
With Interview (+61.1%)
3y 7m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 60 resolved cases by this examiner. Grant probability derived from career allowance rate.

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