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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 22, 2024 has been considered by the examiner.
Claim Objections
Claim 11 is objected to because of the following informalities: acronym “GZMB” should be spelled out prior to first use. Appropriate correction is required.
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.
Claims 1-3, 6-10, 12-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Steinmetz et al. (USPgPub 2021/0361728) and Teshome et al. (Surgical oncology clinics of North America. 2014 Apr 24; 23 (3): 505).
Steinmetz et al. claim a method of treating cancer in a subject, comprising administering in situ to the cancer of the subject a therapeutically effective amount of a cowpea mosaic virus (CPMV) or virus-like particle (VLP) in combination with an immune checkpoint therapy, see claims 1, 3, 4, 5, and 8, as required by instant claims 1, 7, 14, and 19. The CPMV is administered by injection in claim 19, recited in instant claim 13. The immune checkpoint therapy administered by Steinmetz et al. is an inhibitory anti-PD-1 antibody in claims 9 and 10, as required by instant claims 8 and 20. The cancer treated by Steinmetz et al. includes inflammatory breast cancer, listed in paragraph [0081], as required by instant claims 3, 14, and 15. Paragraph [0140-0141] teaches that a combination therapy of CPMV and PD-1 inhibitor, in the absence of chemotherapy, depleted tumor cells by 23-fold compared to the control, as required by instant claims 6, 10, and 18.
In paragraph [0086] Steinmetz et al. teach that the method can (optionally) further include adjuvant therapy, such as chemotherapy, required in instant claims 1, 9, and 14.
Steinmetz et al. do not mention surgical resection following the neoadjuvant combination intratumoral injection, as required by instant claims 1, 12, and 14.
In the first sentence under “Synopsis”, Teshome et al. teach:
Neoadjuvant systemic therapy in the treatment of breast cancer was initially employed for patients with inoperable disease.
In the next to the last sentence under “Synopsis”, Teshome et al. state:
Less invasive surgical strategies such as breast conserving surgery and sentinel lymph node dissection have been shown to be safe following neoadjuvant chemotherapy in selected patients.
Therefore, surgical resection following neoadjuvant cancer therapy is an established treatment regimen. It would have been prima facie obvious to the ordinary artisan prior to the instant effective filing date to follow the established protocol.
Claims 4, 5, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Steinmetz et al. and Teshome et al. as applied to claims 1-3, 6-10, 12-15, and 18-20 above, and further in view of Arias‑Pulido et al. (Breast Cancer Research and Treatment (2018) 171: 273–282).
See the teachings of Steinmetz et al. above. Steinmetz et al. do not mention inflammatory breast cancers at stage III or IV or whether the cancer is PD-L1+, recited in claims 4, 5, 16, and 17.
Arias‑Pulido et al. teach the presence of CD20+ and PD-L1+ tumor-infiltrating lymphocytes in stages 3-4 inflammatory breast cancer is indicative of enhanced treatment outcome, see the abstract, “Clinical specimens”, Table 1, and Figure 2.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have selected patients expressing the PD-L1+ marker in stages 3-4 inflammatory breast cancer for the neoadjuvant treatment method of Steinmetz et al. because Arias‑Pulido et al. correlates this marker with improved patient outcomes.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Steinmetz et al. and Teshome et al. as applied to claims 1-3, 6-10, 12-15, and 18-20 above, and further in view of Cai et al. (Advanced science. 2019 Aug; 6 (16): 1802281).
See the teachings of Steinmetz et al. above. In paragraph [0057], Steinmetz et al. teach the use of in situ delivery of CPMV and an immune checkpoint therapy generates a synergistic antitumor effect due to CD4+ and CD8+ recruitment and activation. However, Steinmetz et al. do not mention decrease of Treg/CD8+, as required.
Cai et al. teach in situ administration of a neoadjuvant, cowpea mosaic virus, depletes the CD8+/ Treg ratio in Figure 6D.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have measured this marker to determine treatment efficacy, see section 2.7 and the Discussion. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success for depleting the CD8+/ Treg ratio, taught by Cai et al. in the method of Steinmetz et al. because Cai et al. teach a method of treating mice with mammary carcinoma 4T1, which shares many commonalities with human metastatic triple-negative breast cancer (TNBC), by in situ administration of CPMV, see the abstract, Introduction, and sections 2.1, 2.4, and Figure 3.
Conclusion
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/Shanon A. Foley/Primary Examiner, Art Unit 1671
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