DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9 September 2025 has been entered.
Claims 1 and 11 have been amended. It is noted that claim 11 is identified as “Previously Presented,” however this claim has been amended. Claim 8 has been cancelled. Claims 1-5, 7, 9-15, and 17-19 are currently pending and under examination.
This application is a continuation application of U.S. Application No. 16/836003, filed March 31, 2020, now U.S. Patent No. 11,439,669, which is a continuation application of U.S. Application No. 14/781273, filed September 29, 2015, now U.S. Patent No. 10,617,723, which is a U.S. National Stage Application of International Application No. PCT/US2014/032196, filed March 28, 2014, which claims benefit to U.S. Provisional Application No. 61/806497 filed March 29, 2013.
Withdrawal of Rejections:
The rejection of claims 1-5, 7-13, 15, and 17-19 under 35 U.S.C. 103 as being unpatentable over Agrawal et al., is withdrawn.
The rejection of claims 1, 13, and 14 under 35 U.S.C. 103 as being unpatentable over Agrawal et al., and further in view of Van Mellaert et al., is withdrawn.
The rejection of claims 1-5, 7-13, 15, and 17-19 on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent Nos. 8,007,782; 8,444,963; and 8,901,100, is withdrawn.
New Rejections:
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 1-5, 7, 9-13, 15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bell et al. (US 2011/0044937; Published 2011), in view of Bettegowda et al. (IDS; The genome and transcriptomes of the anti-tumor agent Clostridium novyi-NT, Nature Biotechnology, Vol. 24, No. 12, (2006), pp. 1573-1580).
With regard to claims 1-5, 7, 9-13, 15, and 17-19, Bell et al. teach a composition comprising a unit dose of 104 C. novyi spores for treating solid tumors in a host, wherein the unit dose does not comprise additional anti-cancer agents (Abs.; Para. 28, 86; Fig. 2, panel B), and wherein 104 C. novyi spores is fully encompassed within 1x103 to 1x106 CFUs. The composition further includes a pharmacologically acceptable carrier (Para. 47).
It is not specifically taught that the C. novyi spores are C. novyi-NT spores.
Bettegowda et al. teach an attenuated strain of the pathogenic species C. novyi, called C. novyi-NT, in which the phage episome containing the major systemic toxin gene is deleted (p. 1573, Left col., para. 1). When injected in a subject, the C. novyi-NT spores produce substantial anti-tumor effects without excessive toxicity, including against solid tumors (p. 1573, Left col., para. 1).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Bell et al. with Bettegowda et al., because both teach C. novyi spores for treatment of solid tumors in a subject. C. novyi spores having the major systemic toxin gene deleted, that produce substantial anti-tumor effects without excessive toxicity, are known in the art as taught by Bettegowda et al. The use of C. novyi-NT spores as taught by Bettegowda et al. in the unit dose of Bell et al. amounts to the simple substitution of one known type of C. novyi spores for another, and would have been expected to predictable and successfully provide C. novyi spores usable in the unit dose for tumor treatment, with the additional benefit of being less toxic to the subject.
The limitation that the unit dose is “formulated for intratumoral administration” provides for an intended use of the unit dose, and adds no additional components not already present in the claim. As Bell et al. and Bettegowda et al. render obvious the unit dose as claimed, including all components as claimed, the unit dose as rendered obvious is necessarily formulated for intratumoral administration.
Taken together, Bell et al. and Bettegowda et al. render obvious the unit dose as claimed, including all components as claimed. As these components cannot be separated from their properties, the results of debulking, ablating, or microscopically precisely excising cells, including without administration of additional anti-cancer agents, or by a single treatment, of a solid tumor present in a human, the solid tumor including a soft tissue sarcoma, hepatocellular carcinoma, breast cancer, pancreatic cancer, melanoma, and retroperitoneal leiomyosarcoma, would naturally flow from the use of the unit dose as rendered obvious by Bell et al. and Bettegowda et al.
Additionally, while a kit containing a unit dose is not specifically taught, as Bell et al. and Bettegowda et al. render obvious a unit dose as claimed, including all components as claimed, inclusion of the unit dose in a kit for future use would have been obvious to an ordinary artisan. The inclusion of the unit dose as rendered obvious by Bell et al. and Bettegowda et al. in a kit does not render the unit dose non-obvious. Further, the duplication of the unit dose, including to provide 1-4 unit doses in a kit, likewise does not provide a non-obvious feature.
Claims 1, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bell et al. and Bettegowda et al., as applied to claims 1 and 13 above, and further in view of Van Mellaert et al. (IDS; Clostridium spores as anti-tumour agents, TRENDS in Microbiology, Vol. 14, No. 4, (2006), pp. 190-196).
The teachings of Bell et al. and Bettegowda et al. as applied to claims 1 and 13 have been set forth above.
With regard to claim 14, Bell et al. further teach that the composition includes an antibacterial agent (Para. 50), which is an antibiotic. However, it is not specifically taught that the antibiotic is effective to treat or alleviate an adverse side effect caused by the C. novyi CFUs.
Van Mellaert et al. teach a unit dose of C. novyi NT for the treatment of solid tumors (Abs.; p. 192, Right Col., Underlying mechanisms of the anti-tumour effect of Clostridium novyi-NT), where an advantage of using live bacteria for treatment is that in the case of an adverse effect, administration of antibiotics can stop the treatment at any time (p. 195, Left Col., Safety concerns, last 4 lines).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Bell et al. and Bettegowda et al. with Van Mellaert et al., because all teach C. novyi for the treatment of solid tumors. The advantage of having the use of an antibiotic to stop the treatment with C. novyi-NT at any time if an adverse reaction occurs, is known in the art as taught by Van Mellaert et al. The inclusion of an antibiotic with this function in a kit as rendered obvious by Bell et al. and Bettegowda et al. would have been expected to predictably improve the kit, by providing an additional component that can be used to stop treatment if an adverse reaction occurs.
Response to Arguments
All previous art rejections have been withdrawn; therefore, Applicant’s arguments are moot. However, new rejections have been set forth above.
Conclusion
No claims are allowable.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653