Prosecution Insights
Last updated: July 17, 2026
Application No. 18/289,317

DOSING REGIMEN FOR COMBINATION THERAPY TARGETING DLL3 AND PD-1

Non-Final OA §103§DP
Filed
Nov 02, 2023
Priority
May 10, 2021 — provisional 63/186,569 +1 more
Examiner
DUTT, ADITI
Art Unit
1675
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Amgen Inc.
OA Round
1 (Non-Final)
47%
Grant Probability
Moderate
1-2
OA Rounds
1y 3m
Est. Remaining
95%
With Interview

Examiner Intelligence

Grants 47% of resolved cases
47%
Career Allowance Rate
180 granted / 381 resolved
-12.8% vs TC avg
Strong +48% interview lift
Without
With
+47.9%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
22 currently pending
Career history
406
Total Applications
across all art units

Statute-Specific Performance

§101
1.6%
-38.4% vs TC avg
§103
48.9%
+8.9% vs TC avg
§102
10.0%
-30.0% vs TC avg
§112
9.8%
-30.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 381 resolved cases

Office Action

§103 §DP
CTNF 18/289,317 CTNF 82281 1649 As Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 1. 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 Status of Application, Amendments and/or Claims 2. Applicant’s response dated 6/7/2024 is considered and entered into record. Claims 3, 5-6, and 12-18 have been amended. Claims 1-18 are currently pending. Information Disclosure Statement 3. The Information disclosure statements (IDSs) dated 2/20/2024, 4/2/2025, 11/21/2025 and 3/16/2026 are acknowledged and entered into record. Non-patent literature document number 17 of the IDS dated 2/20/2024 is crossed off, as a copy of the citation is not provided in the present application. Objections Specification 07-29 AIA 4. The disclosure is objected to because of the following informalities: Page 26 of the specification erroneously states “EXAMPLE 3” instead of “EXAMPLE 2” in the title. It is noted that there is no “Example 2” in the specification. Please note that para 0064 of the specification describes Figure 1 of Example 2 . Appropriate correction is required. Claim Objection 5. Claim 1 is objected to because of the following informalities: 6. Regarding claim 1, acronyms “DLL3” and “PD-1”, recited should be spelled out for clarity. Claim Rejections - 35 USC § 103 07-20-aia AIA 7. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. 8. Claims 1-18 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Raum et al US 20170037130, 2/9/2017 (IDS), in view of Giffin et al WO 2019/200007, 10/17/2019 (IDS), and in further view of Mo et al ( Brit J Cancer 119: 538-545, 2018), Jiang et al ( Human Vaccines Immunotherapeutics , 15: 1111-1122, 2019) and Price et al ( J Immunother Cancer 8: A245, 2020 – Abstract 403, 1 page. 9. The claims are directed to a method of treating a subject with small cell lung cancer (SCLC) comprising administering an anti-DDL3 agent comprising the amino acid sequence of SEQ ID NOs: 13 and 23, and an anti-PD-1 antibody, wherein the SCLC recurred after at least one platinum based chemotherapy (claim 1); wherein: the dosages and timing of anti-DLL3 administration is as recited in claims 1-6; the anti-PD-1 antibody is nivolumab, pembrolizumab or zeluvalimab (claim 7), which are administered at doses and frequency as set forth in claims 8-11; the platinum-based therapy is platinum-etoposide therapy (claim 16); the administration of anti-DLL3 agent is by IV infusion and the subject is human (claim 18). Claim 12 recites a further administration of one or more chemotherapeutic agents, wherein: the agents are corticosteroid (dexamethasone), saline or tocilizumab (claims 13, 14), which are administered in cycle 1 when the anti-DLL3 is administered (claim 15). 10. Raum et al teach a bispecific antibody construct comprising a first binding domain binding to DLL3, and a second binding domain binding to CD3, wherein SEQ ID NOs: 437, 438, 520 and 519 are 100% identical to instant SEQ ID NO: 13 (Appendix A), and SEQ ID NO: 431 is 100% identical to instant SEQ ID NO: 23 (Appendix B); and a method of treating SCLC using the antibody construct of the invention (Abstract). The reference teaches treating SCLC in a subject, comprising administering an effective amount of the antibody construct (para 0417-0418; claims 26, 27), wherein the administration can be by intravenous infusion (para 0424) ( instant claim 17 ), and wherein the typical dosage ranges from about 0.1 µg/kg to about 30 mg/kg or more (para 0431). Using albumin-fused constructs of the DDL3xCD3 bispecific antibody, Example 20 of the reference shows that once or twice weekly dosing in a human patient provides a favorable pharmacokinetic profile (para 0551), thereby indicating a preference for administration of the antibody construct once every two weeks ( instant claims 1-2, 4 ). Raum et al teach administration of additional anti-cancer therapeutics (proteinaceous or non-proteinaceous drugs) that can be administered with the antibody construct of the invention, which can either be before or after administration of the construct in “timely defined intervals and doses” (i.e. in the cycle where the anti-DLL3 agent is administered) (para 0433) ( instant claim 15 ). Although the reference does not explicitly state that the subjects have recurring SCLC, it is well understood that the initial standard treatment for SCLC is platinum-based chemotherapy, which invariably results in relapsing or recurring SCLC. The reference teaches that patients having SCLC, after being treated with the front-line therapy including etoposide and cisplatin (platinum-based chemotherapy) respond well initially, however, quickly relapse with chemoresistance (SCLC recurred) and poor prognosis (para 0003). Since the inventive antibody construct is considered to “represent a promising new possibility for the treatment of SCLC”, the subject to be treated expectedly has recurring SCLC after undergoing the standard platinum-based chemotherapy (paras 0003, 0008) ( instant claims 1, 16 ). 11. Raum et al do not teach administration of anti-PD-1 antibody. 12. Giffin et al teach a chimeric antigen receptor comprising an antigen binding molecule or antibodies that specifically bind to DLL3 (anti-DLL3 agent) and an activating (another) domain comprising CD3 (para 0008, 0011, 0012, 0021, 0068, 0069; claims 1, 3, 11 ) , wherein the antibodies can be bispecific (para 0114). Please note that para 0013 of the instant specification teaches that “anti-DLL3 agent is a bispecific T cell engaging antigen-binding polypeptide comprising two domains: the first domain binds to …”DLL3 and the second domain to CD3. The reference teaches treating a subject having SCLC comprising administering the construct with anti-DLL3 and CD3 domain (para 0029, 0131, 0134; claims 74, 77, 79), where the subject is a human (para 0192). The reference also teaches additional or further administration of PD-1 inhibitors (antibodies) such as nivolumab, pembrolizumab (para 0142), and steroids like dexamethasone (para 0144, 00132). ( instant claims 1, 7,12-14, 18 ). 13. Raum et al, or Giffin et al do not teach all the PD-1 antibodies recited in claims 7-11. 14. Mo et al teach that PD-1 inhibition is one of most potential treatment strategies in solid tumors of a variety of cancers including lung cancer, and PD-1 antibodies like nivolumab, pembrolizumab have resulted in remarkable response in different cancers. (Introduction, para 1). The reference teaches that the antibodies are administered based upon body weight or at a fixed dose, and pembrolizumab is administered at 200 mg every 3 weeks (Introduction, para 2). ( instant claim 8 ) 15. Jiang et al teach the presence of abnormally high levels of programmed death-ligand 1 or PD-L1 (ligand of PD-1) expression on tumor cells, and that the development of anti-PD-1/PD-L1 antibodies is a “hot topic in cancer immunotherapy” (Abstract). The reference also teaches a clinical trial treating SCLC (in human subjects) with 3 mg/kg every 2 weeks (once every 2 weeks) of nivolumab in combination therapy (Table 2). It is noted that considering an average adult in the US weighs around 80 kgs, the dose to be administered would be 240 mg, of instant claim 9. 16. Price et al teach evaluation of pharmacokinetics and efficacy of AMG 404 (also known as zeluvalimab as stated in para 00100, page 17 of instant specification) in adult patients with advanced solid tumors (Background). It is well known that SCLC is a solid tumor. The abstract concludes that AMG 404 is tolerable at all tested doses, and provides encouraging anti-tumor activity (Conclusions). 17. Even though Raum et al teach dose ranges (for anti-DLL3 agent or bispecific antibody) overlapping with the instant ranges of claims 1, 2 and 4, Raum et al or any of the cited references do not teach the individual doses and timing as claimed in instant claims 3, 5, 6. Raum et al also teach that the proper dose can be adjusted based upon the judgement of the attending physician such that the administration results in an optimal therapeutic effect, wherein the doses can depend upon the patient’s clinical history, prior treatment, etc. (para 0430). The cited art also does not explicitly teach the dosages and timings of the anti-PD-1 antibodies as recited in claims 9-10. 18. Since the anti-DLL3xCD3 construct and anti-PD-1 antibodies are known for treating cancer and in particular SCLC in the prior art, the doses and administration timing can well be adjusted by an attending physician as also taught in the Raum reference. The differences between the claimed method and the prior art method appears to be one of optimization of conditions of administration. It would therefore, have been obvious to one of ordinary skill in the art at the time the invention was made to have optimized the administration conditions of anti-DDL3 agent and anti-PD-1 antibodies to arrive at the administration conditions recited in the claims. See MPEP 2144.05: A. Optimization Within Prior Art Conditions or Through Routine Experimentation. Generally, differences in dosage or timing will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameters are critical. Dosages and schedule of administration are results-effective variables which can be optimized. In the case of administering the bispecific antibody and anti-PD-1 antibody, one of skill in the art would clearly recognize that doses and administration timings could easily be optimized by a treating physician based on the clinical needs and physiology of the individual patient. In in re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980), it was held that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." 19. It would have been, therefore, obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to modify the administration of an anti-DLL3 agent comprising a bispecific antibody DLL3xCD3 construct that is clinically validated and would provide new treatment options for treating recurring SCLC, as taught by Raum et al., by also administering anti-PD-1 antibody to said patients, in view of Giffin et al, wherein the anti-PD-1 antibody is nivolumab, pembrolizumab or zeluvalimab as taught by Jiang et al, Mo et al and Price et al respectively. The person of ordinary skill would find it obvious to use the combination of anti DDL3 agent and anti-PD1 antibody for treating cancer as both, have been individually taught to treat lung cancer In re Kerkhoven ,205 USPQ 1069 (CCPA 1980). The person of ordinary skill would have been motivated to also administer anti-PD-1 antibody, as PD-1 inhibition is one of most potential treatment strategies in solid tumors including lung cancer, and PD-1 antibodies like nivolumab, pembrolizumab have resulted in remarkable response in cancer (Mo et al). The person of ordinary skill in the art would also have been motivated to use a bispecific DLL3xCD3 construct for treating SCLC, as SCLC “remains a significant unmet medical need” with low survival rates for several decades, and DLL3 being a SCLC specific tumor antigen (para 0005), the “antibody construct targeting DLL3 and CD3 represents a promising new possibility for the treatment of SCLC” (Raum et al para 0002, 0005, 0008). The person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of the prior art references, before the effective filing date of the instant invention. 20. Thus, the claimed invention as a whole was prima facie obvious over the combined teachings of the prior art. Double Patenting Non-Statutory 08-33 AIA 21. 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). 22. 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). 23. 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. 24. 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. 25. Claims 1-6 and 16 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 14-16 of US Patent 10,294,300 in view of Giffin et al (2019). Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to a method of treating SCLC comprising administering to the subject an effective amount of an anti-DLL3 agent or a bispecific antibody that binds to DLL3 (first binding domain) and CD3, wherein the first binding domain comprises an amino acid sequence of SEQ ID NOs: 437, 438, 519, 520 (claims 10-12) that are 100% identical to instant SEQ ID NO: 13 (Appendix A). The only differences between the 2 sets of claims are: i) Instant claim 1 recites SEQ ID NO: 23 (corresponding to CD3 domain) while the ‘300 patent claims do not recite sequences of the second domain. However, SEQ ID NO: 431 of the ‘300 patent (para 0217) corresponds to the second binding domain and comprise an amino acid sequence that is 100% identical to instant SEQ ID NO: 23. (Appendix B) ii) Instant claims recite the dosing parameters, while the ‘300 patent claims are silent on this aspect. However, this would be obvious as para 0430-0431 of the patent PGPB teach a dose range of 1 µg/kg to 20 mg/kg depending on various factors like prior therapy etc., wherein the proper dose and timing can be adjusted based on the judgement of the physician by routine optimization. iii) Instant claims recite recurrence after prior platinum-based chemotherapy, while ‘300 patent claims do not have such recitation. However, this would be obvious in view of the ‘300 PGPB (para 0003) which evinces that SCLC patients treated with etoposide and cisplatin (platinum-based chemotherapy – see para 134 of instant specification) relapse with chemoresistant disease (recurrence of SCLC). iv) Instant claims recite administering anti-PD-1, while the ‘300 patent claims do not have this limitation. However, the administration of anti-PD-1 antibody would be obvious in view of the teachings of Giffin et al for reasons stated above. 26. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 10,294,300. 27. Claims 1-6, are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1, 11, 14, 18-20, of US Patent 10,683,351 in view of Giffin et al (2019). Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims recite the same bispecific antibody (anti-DLL3 agent) comprising a 1 st binding domain binding to DLL3 and a 2 nd binding domain binding to CD3, wherein the first and second binding domains comprise an amino acid sequence of (SEQ ID NOs: 437, 438, 519, 520) and (SEQ ID NO: 431) (claims 11, 14, 18-20) that are 100% identical to instant SEQ ID NOs: 13 and 23 (Appendix C, D). The only differences between the 2 sets of claims are: i) ‘351 claims recite a nucleic acid encoding the bispecific antibody, while instant claims do not recite a nucleic acid. However, the making of proteins or antibodies by expressing in a host cell in culture is a well-known standard process, which is also taught in para 0058 of the instant specification. ii) Instant claims are to a method of treating SCLC comprising the antibody and anti-PD-1, while the ‘351 claims do not recite such treatment. However, this would be obvious in view of Giffin et al for reasons stated above. iii) Instant claims recite the dosing parameters, while the ‘351 claims are silent on this aspect. However, this would be obvious as paras 0423-0424 of the patent PGPB teach a dose range of 1 µg/kg to 20 mg/kg depending on various factors like prior therapy etc., wherein the proper dose and timing can be adjusted based on the judgement of the physician by routine optimization. iv) Instant claims recite recurrence after prior platinum-based chemotherapy, while ‘351 patent claims do not have such recitation. However, this would be obvious in view of the ‘351 PGPB (para 0003) which evinces that SCLC patients treated with etoposide and cisplatin (platinum-based chemotherapy – see para 134 of instant specification) relapse with chemoresistant disease (recurrence of SCLC). 28. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 10,683,351. 29. Claims 1-6 and 16 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 5, 22-23 of US Patent 11,591,396 in view of Giffin et al (2019). Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to a method of treating SCLC comprising administering to the subject an effective amount of an anti-DLL3 agent or a bispecific antibody that binds to DLL3 (first binding domain) and CD3, wherein the first and second binding domains comprise an amino acid sequence of SEQ ID NOs: 437 and 431 (claims 10,17, 5) that are 100% identical to instant SEQ ID NOs: 13 and 23 (Appendix E, F) . The only differences between the 2 sets of claims are: i) Instant claims recite the dosing parameters, while the ‘396 patent claims are silent on this aspect. However, this would be obvious as para 0429-0430 of the patent PGPB teach a dose range of 1 µg/kg to 20 mg/kg depending on various factors like prior therapy etc., wherein the proper dose and timing can be adjusted based on the judgement of the physician by routine optimization. ii) Instant claims recite recurrence after prior platinum-based chemotherapy, while ‘396 patent claims do not have such recitation. However, this would be obvious in view of the ‘396 PGPB (para 0003) which evinces that SCLC patients treated with etoposide and cisplatin (platinum-based chemotherapy – see para 134 of instant specification) relapse with chemoresistant disease (recurrence of SCLC). iii) Instant claims recite administering anti-PD-1, while the ‘396 patent claims do not have this limitation. However, the administration of anti-PD-1 antibody would be obvious in view of the teachings of Giffin et al for reasons stated above. 30. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 11,591,396. 31. Claims 1-18 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 4, 7-9, 14-18, 31-33, 40-41, 45-48, 50-52, 54, 56-57, and 60-61 of co-pending application 18/836,031. Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to a method of treating cancer or SCLC comprising administering an anti-DLL3 agent comprising SEQ ID NOs: 13 and 23, which are 100% identical to instant SEQ ID NOs: 13 and 23; wherein the cancer is recurring (relapsed) after one prior treatment comprising platinum chemotherapy comprising etoposide; the anti-DDL3 treatment further comprising administration of anti-PD-L1 antibody, and corticosteroid, saline or anti-IL6 antibody (tocilizumab); and the anti-DDL3 agent is administered by IV infusion. The only differences between the 2 sets of claims are: i) Instant claims recite PD-1 antibodies, which are different from those recited in ‘031 claims. However, since both sets of claims recite the administration of PD-1/PD-L1 antibodies in addition to anti-DLL3 agent for treating recurring SCLC, wherein both PD-1 and PD-L1 antibodies are used for treating DDL3 positive cancers (para 0075 of the ‘031 PGPB), it would be obvious to one of ordinary skill in the art to have a simple substitution of functionally equivalent elements, i.e., the substitution of PD-1 for PD-L1 antibodies with predictable results (MPEP 2143 (B)). ii) Even though the amounts and timing of administration of instant and ‘031 claims are overlapping, they are not identical. However, since the antibody and additional therapeutics are the same and are administered by IV infusion for treating recurring SCLC in subjects in both sets of claims, the dosing parameters can obviously be established by routine optimization by a skilled physician based upon the needs of the patient and condition. 32. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented. 33. Claims 1-18 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4, 47-51, 53, 55 of co-pending application 17/775,520 in view of Giffin et al (2019). Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to a method of treating cancer or SCLC comprising administering an anti-DLL3 agent comprising SEQ ID NOs: 438, 520 (both of which are 100% identical to instant SEQ ID NO: 13), wherein the agent is administered at a dose of 10, 30 or 100 mg once every two weeks, and is administered on days 1 and 15 of a 28 day cycle; the method further comprising administering saline, corticosteroid or dexamethasone, or anti-IL6 antibody (tocilizumab), wherein the anti-DDL3 agent is administered by IV infusion. The only differences between the 2 sets of claims are: i) Instant claims recite admin an anti-PD1 ab, while ‘520 claims are silent. However, treating SCLC by administration of anti-PD1 antibodies along with anti DDL3 agent would be obvious in view of the teachings of Giffin et al as stated above. ii) Even though the amounts and timing of anti-DLL3 agent administration of instant and 031 claims are overlapping, they are not identical. However, since the antibody and additional therapeutics are the same and are administered by IV infusion for treating SCLC in subjects in both sets of claims, the dosing parameters can obviously be established by routine optimization by a skilled physician based upon the needs of the patient and condition. 34. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented. 35. Claims 1-6, are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3, 31-32 and 107 of co-pending app 18/026,505 of in view of Raum et al (2017), and Giffin et al (2019). Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to a method of treating SCLC comprising administering a bispecific T-cell engaging molecule comprising DDL3 and CD3 once every 14 days (two weeks). The only differences between the 2 sets of claims are: i) Instant claims recite specific sequences, while the ‘505 claims are broad. However, both sets of claims recite the same construct, whose sequences would be obvious in view of Raum et al for reasons stated above. ii) Instant claims recite recurrence after prior platinum-based chemotherapy, while the ‘505 claims do not have such recitation. However, this would be obvious in view of the ‘505 PGPB (para 0343) which teaches that SCLC patients will include those with recurrence after one platinum-based therapy. iii) Instant claims recite administering an anti-PD1 antibody, while the ‘505 claims do not have this limitation. However, treating SCLC by administering anti-PD1 antibody along with an anti DDL3 agent would be obvious in view of the teachings of Giffin et al as stated above. 36. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented. 37. Claims 1-6, 12, 16 and 18 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, 6-7, 9-10, 12, 19-21, 23-24, 26-27, 29, 37-38, 51-52 of co-pending app 19/135,304. Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to a method of treating cancer or SCLC that has recurred following a platinum based treatment in a human subject, comprising administering an anti-DLL3 agent (tarlatamab) (having DDL3 and CD3 as the first and second binding domains), wherein the agent is administered at a dose of 10 to 100 mg once every two weeks; the method further comprising administration of PD-L1 (PD-1 – see para 0127 of 304 spec) inhibitor and chemotherapeutic agent. The only difference between the 2 sets of claims is: ‘304 claims recite expression percent of DDL3 in SCLC cells, which is not present in instant claims. However, the “wherein” clause in claims 1, 2 of 304 application, only describes a property of SCLC cells, which would necessarily be present on the same cells. 38. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented. Conclusion 39. No claims are allowed. 40. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aditi Dutt whose telephone number is (571)272-9037. The examiner can normally be reached on M-F 9:00am-5:00pm. 41. 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. 42. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker, can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 43. 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. /A. D./ Examiner, Art Unit 1675 9 June 2026 /KIMBERLY BALLARD/Primary Examiner, Art Unit 1675 Application/Control Number: 18/289,317 Page 2 Art Unit: 1649 Application/Control Number: 18/289,317 Page 3 Art Unit: 1649 Application/Control Number: 18/289,317 Page 4 Art Unit: 1649 Application/Control Number: 18/289,317 Page 5 Art Unit: 1649 Application/Control Number: 18/289,317 Page 6 Art Unit: 1649 Application/Control Number: 18/289,317 Page 7 Art Unit: 1649 Application/Control Number: 18/289,317 Page 8 Art Unit: 1649 Application/Control Number: 18/289,317 Page 9 Art Unit: 1649 Application/Control Number: 18/289,317 Page 10 Art Unit: 1649 Application/Control Number: 18/289,317 Page 11 Art Unit: 1649 Application/Control Number: 18/289,317 Page 12 Art Unit: 1649 Application/Control Number: 18/289,317 Page 13 Art Unit: 1649 Application/Control Number: 18/289,317 Page 14 Art Unit: 1649 Application/Control Number: 18/289,317 Page 15 Art Unit: 1649 Application/Control Number: 18/289,317 Page 16 Art Unit: 1649 Application/Control Number: 18/289,317 Page 17 Art Unit: 1649 Application/Control Number: 18/289,317 Page 18 Art Unit: 1649
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Prosecution Timeline

Nov 02, 2023
Application Filed
Jun 18, 2026
Non-Final Rejection mailed — §103, §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
47%
Grant Probability
95%
With Interview (+47.9%)
4y 0m (~1y 3m remaining)
Median Time to Grant
Low
PTA Risk
Based on 381 resolved cases by this examiner. Grant probability derived from career allowance rate.

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