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 .
The preliminary amendments are received.
Claims 1-9 and 18-45 are canceled, and new claims 46-53 are added by Applicant.
Claims 10-17 and 46-53 are pending in this application and are being examined.
Objection(s):
Claim(s):
Claims 12, 13, 46 and 47 are objected to because of the following informalities:
In claim 12, replace “Salmonella Typhimurium” with --Salmonella Typhimurium--.
In claim 13, replace “bacterium” with --Salmonella Typhimurium--.
In claim 46, replace “Salmonella Typhimurium” with --Salmonella Typhimurium--.
In claim 47, replace “bacterium” with --Salmonella Typhimurium--.
Appropriate correction is required.
Specification:
The use of the term, for example, page 2, Doxil®, Onivyde®, Marqibo®, and DaunoXome®, which are trade names or a marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejection - 35 USC §102
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.
Claims 10, 11, 14, 16, 17 and 48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheong et al. (Science. 2006, Vol. 314, No. 5803, p. 1308-1311).
Regarding claim 10, Cheong et al. disclose a method for treating a malignant tumor in a subject, comprising a step of administering an effective amount of a combination of a bacterium and a liposome encapsulating an anti-malignant tumor agent to the subject (combined attenuated strain of C. novyi with liposome-encapsulated doxorubicin injected to colorectal tumors in mice, administered a single intravenous dose, combination of C. novyi with liposome-encapsulated doxorubicin resulted in complete regression of tumors in 100% of mice, etc.) (See for example, p. 1308 right-hand column -Continued on p. 1309).
Regarding claim 11, Cheong et al. disclose the step of administering to the subject is a step of separately formulating the bacterium and the liposome encapsulating an anti-malignant tumor agent and administering them in combination to the subject (administered as a single intravenous dose) (See for example, p. 1308 right-hand column).
Regarding claim 14, Cheong et al. disclose the anti-malignant tumor agent is doxorubicin or a pharmaceutically acceptable salt thereof (liposomal formulation encapsulating doxorubicin) (See for example, p. 1308 right-hand column).
Regarding claim 16, Cheong et al. disclose the malignant tumor in the subject is a solid cancer (colorectal cancer tumors) (See for example, p. 1308 right-hand column).
Regarding claim 17, Cheong et al. disclose the solid cancer is a cancer selected from the group consisting of lung cancer, pancreatic cancer, glioblastoma, ovarian cancer, Kaposi's sarcoma, multiple myeloma, breast cancer, osteosarcoma, esophageal cancer, liver cancer, gastric cancer, pancreatic cancer, colorectal cancer, rectal cancer, colon cancer, ureter tumor, brain tumor, gall bladder cancer, bile duct cancer, biliary tract cancer, renal cancer, bladder cancer, cervical cancer, prostate cancer, thyroid cancer, orchis tumor, maxilla cancer, tongue cancer, lip cancer, oral cavity cancer, pharyngeal cancer, laryngeal cancer, myosarcoma, and skin cancer (colorectal cancer tumors) (See for example, p. 1308 right-hand column).
Regarding claim 48, Cheong et al. disclose the anti-malignant tumor agent is doxorubicin or a pharmaceutically acceptable salt thereof (liposomal formulation encapsulating doxorubicin) (See for example, p. 1308 right-hand column).
Cheong et al. therefore anticipate the claimed method for treating a malignant tumor in a subject.
Claim Rejection - 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.
A)
Claims 10, 11, 14-17, 48 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Cheong et al. (Science. 2006, Vol. 314, No. 5803, p. 1308-1311)as applied to claims 10, 11, 14, 16, 17 and 48 above, and further in view of Kipps et al. (Therapeutic Advances in Medical Oncology. 2017;9(3):159-170).
The teachings of Cheong et al. with respect to the limitations of claims 10, 11, 14, 16, 17 and 48 were discussed above (See 102 rejection above).
Cheong et al. do not teach the anti-malignant tumor agent is irinotecan or a pharmaceutically acceptable salt thereof (claims 15 and 51).
However, regarding claims 15 and 51, before the effective filing date of the invention, Kipps et al. teach liposomal encapsulated irinotecan as anti-malignant tumor agent with reduced toxicity and increased tumor efficacy (See for example, p. 162 left-hand column last paragraph -Continued on right-hand column).
Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been motivated to substitute the anti-malignant tumor agent, i.e., irinotecan, taught y Kipps et al. for the anti-malignant tumor agent in the method of Cheong et al. with a reasonable expectation of success in providing the claimed method for treating a malignant tumor in a subject. Because substitution of one known anti-malignant tumor agent for another taught by the prior art would have been obvious. Because Kipps et al. teach liposomal encapsulated irinotecan as anti-malignant tumor has reduced toxicity and increased tumor efficacy.
B)
Claims 10-17 and 46-53 are rejected under 35 U.S.C. 103 as being unpatentable over Diamond et al. (WO 2015/002969 A1, which is cited in IDS filed on 12/18/2024) in view of Kipps et al. (Therapeutic Advances in Medical Oncology. 2017;9(3):159-170).
Regarding claim 10, Diamond et al. teach a method for treating a malignant tumor in a subject, comprising a step of administering an effective amount of a combination of a bacterium and a liposome encapsulating an anti-malignant tumor agent to the subject (method administering of tumor penetrating agent and bacterial cells, in effective amount, the of tumor penetrating agent is liposomes as delivery vehicles, treating cancer in a subject, the cancer refers to malignant tumors, including Advanced pancreatic ductal adenocarcinoma (PDAC), etc.) (See for example, p. 1 paragraphs [0002] and [0003], p. 10 paragraph [0037], p. 27 paragraphs [0078] - [0080], p. 28 paragraphs [0081], [0082] and [0083], and p. 14 paragraph [0050]).
Regarding claim 11, Diamond et al. teach the step of administering to the subject is a step of separately formulating the bacterium and the liposome encapsulating an anti-malignant tumor agent and administering them in combination to the subject (agents administered concomitantly as a mixture, etc.) (See for example, p. 29 paragraph [0086]).
Regarding claim 12, Diamond et al. teach the bacterium is an attenuated strain of Salmonella Typhimurium and is selected from the group consisting of VNP20009, Al-R, SHJ2037, SL3261, SL7207, BRD509, and YB1 (attenuated strain of Salmonella Typhimurium is VNP20009) (See for example, p. 17 paragraph [0055]).
Regarding claim 13, Diamond et al. teach the bacterium is VNP20009 (attenuated strain of Salmonella Typhimurium is VNP20009) (See for example, p. 17 paragraph [0055]).
Regarding claim 14, Diamond et al. teach the anti-malignant tumor agent is doxorubicin or a pharmaceutically acceptable salt thereof (doxorubicin) (See for example, p. 28 line 2).
Regarding claim 16, Diamond et al. teach the malignant tumor in the subject is a solid cancer (the cancer refers to malignant tumors, including Advanced pancreatic ductal adenocarcinoma (PDAC) (See for example, p. 1 paragraph [0002]).
Regarding claim 17, Diamond et al. teach the solid cancer is a cancer selected from the group consisting of lung cancer, pancreatic cancer, glioblastoma, ovarian cancer, Kaposi's sarcoma, multiple myeloma, breast cancer, osteosarcoma, esophageal cancer, liver cancer, gastric cancer, pancreatic cancer, colorectal cancer, rectal cancer, colon cancer, ureter tumor, brain tumor, gall bladder cancer, bile duct cancer, biliary tract cancer, renal cancer, bladder cancer, cervical cancer, prostate cancer, thyroid cancer, orchis tumor, maxilla cancer, tongue cancer, lip cancer, oral cavity cancer, pharyngeal cancer, laryngeal cancer, myosarcoma, and skin cancer (See for example, p. 14 paragraph [0050] –Continued on p. 15).
Regarding claim 46, Diamond et al. teach the bacterium is an attenuated strain of Salmonella Typhimurium and is selected from the group consisting of VNP20009, Al-R, SHJ2037, SL3261, SL7207, BRD509, and Ybl (attenuated strain of Salmonella Typhimurium is VNP20009) (See for example, p. 17 paragraph [0055]).
Regarding claim 47, Diamond et al. teach the bacterium is VNP20009 (attenuated strain of Salmonella Typhimurium is VNP20009) (See for example, p. 17 paragraph [0055]).
Regarding claims 48-50, Diamond et al. teach the anti-malignant tumor agent is doxorubicin or a pharmaceutically acceptable salt thereof (doxorubicin) (See for example, p. 28 line 2).
Diamond et al. do not teach the anti-malignant tumor agent is irinotecan or a pharmaceutically acceptable salt thereof (claims 15 and 51-53).
However, regarding claims 15 and 51-53, before the effective filing date of the invention, Kipps et al. teach liposomal encapsulated irinotecan as anti-malignant tumor agent for treating cancer with reduced toxicity and increased tumor efficacy (See for example, p. 162 left-hand column last paragraph -Continued on right-hand column).
Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been motivated to substitute the anti-malignant tumor agent, i.e., irinotecan taught by Kips et al. for the anti-malignant tumor agent in the method of Diamond et al. with a reasonable expectation of success in providing the claimed method. Because substitution of one known anti-malignant tumor agent for another taught by the prior art would have been obvious. Because Kipps et al. teach liposomal encapsulated irinotecan as anti-malignant tumor with reduced toxicity and increased tumor efficacy.
Conclusion(s):
No claim(s) are allowed at this time.
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/KADE ARIANI/Primary Examiner, Art Unit 1651
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