DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 10, 2026 has been entered.
3. Claims 10-14 and 16-20 are pending.
Claims 10-14 and 16-20 are examined on the merits.
4. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Withdrawn Grounds of Rejection
Claim Rejections - 35 USC § 102
5. The rejection of claim(s) 10 and 16 is/under 35 U.S.C. 102(a)(1) as being anticipated by Cao et al., WO 2016/054555 A2 (published 7 April 2016) is withdrawn in light of Applicant’s arguments presented in the Remarks submitted May 14, 2026, see pages 4-7.
6. The rejection of claim(s) 10-13 and 16-19 under 35 U.S.C. 102(a)(2) as being anticipated by Dranoff et al., WO 2017/019896 A1 (effective filing date 28 July 2016) is withdrawn in light of Applicant’s arguments presented in the Remarks submitted May 14, 2026, see pages 4-7.
Claim Rejections - 35 USC § 103
7. The rejection of claim(s) 10-14 and 16-20 under 35 U.S.C. 103 as being unpatentable over Cao et al., WO 2016/054555 A2 (published 7 April 2016), and further in view of Korman et al., WO 2018/222711 A2 (effectively filed 30 May 2017) is withdrawn in light of Applicant’s arguments presented in the Remarks submitted May 14, 2026, see pages 10 and 11.
8. The rejection claim(s) 10-14 and 16-20 under 35 U.S.C. 103 as being unpatentable over Dranoff et al., WO 2017/019896 A1 (effective filing date 28 July 2016), and further in view of Korman et al., WO 2018/222711 A2 (effectively filed 30 May 2017) is withdrawn in light of Applicant’s arguments presented in the Remarks submitted May 14, 2026, see pages 15-17.
Claim Rejections - 35 USC § 103
9. 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.
10. Claim(s) 10-13 and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li, Lixin, US 2017/0114137 (filed January 9, 2017), and further in view of Kümler et al., (BMC Cancer 15:78, 2015/ IDS reference #12 submitted September 30, 2022). Li teaches treating cancers including breast cancer with combination therapy, including an anti-PD-L1 with an anticancer agent, an inhibitor of topoisomerase including camptothecin (CPT), see abstract; page 2, sections 0017-0020, 0029; page 3, sections 0038 and 0043; section 0134 bridging pages 9 and 10; page 48, sections 0374-0376, 0382, 0385; page 49, section 0386; and claims 1, 2, 6-8, 15-17, 19, 20 spanning pages 53-55. The anti-PD-L1 binding antibody may be MPDL3280A, art known as atezolizumab; MEDI 4736, art known as durvalumab; and MSB0010718C, art known as avelumab, see page 2, sections 0017, 0020.
Li does not explicitly teach the inhibitor of topoisomerase is irinotecan (CPT-11).
However, Kümler teaches treating locally advanced and metastatic HER2-negative breast cancer patients with irinotecan. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Li and Kümler to implement topoisomerase inhibitor, irinotecan, a CPT analogue with a variety of different PD-L1 antibodies as these antibodies bind to the same epitope region and share functional properties, see Li, Abstract and entire document; and entire Kümler document.
One of ordinary skill in the art would have been motivated to modify the method of Li with the substitution of CPT with CPT-11 with a reasonable expectation of success by teachings in both references given the success of treating the breast cancer patients with the class of CPTs, see both documents in their entireties.
11. Claim(s) 10-14 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li, Lixin, US 2017/0114137 (filed January 9, 2017), and further in view of Kümler et al., (BMC Cancer 15:78, 2015/ IDS reference #12 submitted September 30, 2022) and Korman et al., WO 2018/222711 A2 (effectively filed 30 May 2017). Li teaches treating cancers including breast cancer with combination therapy, including an anti-PD-L1 with an anticancer agent, an inhibitor of topoisomerase including camptothecin (CPT), see abstract; page 2, sections 0017-0020, 0029; page 3, sections 0038 and 0043; section 0134 bridging pages 9 and 10; page 48, sections 0374-0376, 0382, 0385; page 49, section 0386; and claims 1, 2, 6-8, 15-17, 19, 20 spanning pages 53-55. The anti-PD-L1 binding antibody may be MPDL3280A, art known as atezolizumab; MEDI 4736, art known as durvalumab; and MSB0010718C, art known as avelumab, see page 2, sections 0017, 0020.
Li does not explicitly teach the inhibitor of topoisomerase is irinotecan (CPT-11) and the anti-PD-L1 antibody is KN035, CX-072, LY3300054 and FAZ053.
However, Kümler teaches treating locally advanced and metastatic HER2-negative breast cancer patients with irinotecan. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Li and Kümler to implement topoisomerase inhibitor, irinotecan, a CPT analogue with a variety of different PD-L1 antibodies as these antibodies bind to the same epitope region and share functional properties, see Li, Abstract and entire document; and entire Kümler document.
One of ordinary skill in the art would have been motivated to modify the method of Li with the substitution of CPT with CPT-11 with a reasonable expectation of success by teachings in both references given the success of treating the breast cancer patients with the class of CPTs, see both documents in their entireties.
Moreover, Korman teaches “…an anti-PD-L1 antibody is atezolizumab, durvalumab, avelumab, LY3300054, CX-072, FAZ053, KN035, see page 5, section 0014.
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Li and Korman to implement a variety of different PD-L1 antibodies as these antibodies bind to the same epitope region and share functional properties, see Abstract; and pages 32-34.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in Li, Kümler and Korman, PD-L1 antibodies with an additional anticancer therapeutic can contribute to tumor shrinkage, suppression of tumor growth and enhanced response rate in the treatment of breast cancer, see Li and Kümler in their entirety; and Korman in its entirety and in particular, VII. Outcomes on page 42.
Conclusion
12. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
- Iwai et al. Irinotecan Augmented Anti-Tumor Activity of Anti-PD L1 through Enhancing CD8 Proliferation Regardless of Its Hematotoxicity. Abstracts S2417: P2.07-006. Journal of Thoracic Oncology Vol. 12, No. 11S2. November 2017.
13. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached between 8AM-8PM, Monday through Friday.
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, Julie Wu can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
September 2, 2026
/Alana Harris Dent/Primary Examiner, Art Unit 1643
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