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 .
DETAILED ACTION
Claims 1-14 are pending in the present application file.
Priority
The following continuity data is acknowledged in the present application file:
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Information Disclosure Statement
The Information Disclosure Statement(s) filed 12/06/2024 and 04/03/2025 have been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “potentiates” in claim 1 is a relative term which renders the claim indefinite. The term “potentiates” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As the claim further recites the phrase “an effect”, it is unclear what biomarker, symptom or effect is needed to be measured and at what level of change in level or effect is required to meet the scope of the present claims.
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.
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/242923 A1 (Sengupta et al.; Published 03/12/2020; International Filing Date 05/22/2020), in view of US 2002/0002162 (Lee).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Sengupta discloses a method of treating cancer comprising directing radiation to the cancer or tumor and administration of a composition comprising a benzodiazepine derivative in combination with an anticancer agent or combination of anticancer agents. See page 8, last paragraph. Sengupta discloses wherein the cancer comprises lung brain metastasis or glioblastoma. See page 2, lines 18-22 and present claim 1 and 8. Sengupta discloses where the benzodiazepine derivative is BZD-1. See page 51, lines 5-24; page 53, lines 20-21. Sengupta discloses wherein the anticancer agents comprise chemotherapeutic agents such as temozolomide and docetaxel and anticancer agents. See page 8, lines 4 and 13 and present claims 2-6 and 11. Sengupta discloses where BZD-1 and the anticancer agent are administered sequentially. See page 9, lines 5-10 and present claims 7, 9 and 12.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Sengupta does not disclose where effect of anti-cancer drug is potentiated in a subject diagnosed with cancer.
Sengupta does not disclose where cancer is lung cancer selected from the group consisting of non-small cell lung cancer (NSCLC), adenocarcinoma, large cell lung carcinoma (LCLC), and squamous cell carcinoma.
Finding of prima facie obviousness --- rationale and motivation. (See
MPEP § 2142-2143)
Lee discloses synergistic method for treatment of cancer comprising combination of benzodiazepine and anticancer agent. See paragraphs [0011]-[0019], [0054], [0108]-[0109].
Lee discloses where cancer is non-small cell lung cancer (NSCLC), although synergistic combination can be suitable for various cancers. See paragraphs [0059]-[0066] and present claims 1, 11 and 13.
Lee discloses where anticancer agent includes temozolomide and docetaxel. See paragraph [0070]-[0071] and [0120].
Lee discloses where temozolomide is administered at a dose lower than an effective dose when administered as standalone therapy. See paragraph [0054] and present claims 8 and 14. Lee discloses where “synergy between the active ingredients allows for the use of smaller doses of one or both active ingredients, allows for the use of lower doses of the antineoplastic agents or agent or radiation therapy, provides greater efficacy at the same doses, and/or prevents or delays the build-up of multi-drug resistance”
Sengupta discloses a method of treating lung cancer comprising a benzodiazepine including BZD-1 and anticancer agents including temozolomide and docetaxel. Lee discloses a method of treating lung cancer, particularly NSCLC, comprising a benzodiazepine and anticancer agents including temozolomide and docetaxel. It would have been obvious to combine the methods of Sengupta and Lee to provide a method of treating lung cancer, and particularly NSCLC, and glioblastoma given a combination of benzodiazepines, such as BZD-1, and anticancer agents, such as temozolomide and docetaxel. As both Lee and Sengupta are related to the same field of endeavor, treating cancer, and Lee provides synergistic compositions comprising benzodiazepines and various anticancer agents which allow for the administration of lower doses of the anticancer agent compared to when administered as a standalone therapy, there would be a reasonable expectation of success of potentiating an anticancer agent in the treatment of NSCLC and glioblastoma.
Regarding claim 10, as the combination of Sengupta and Lee discloses a method for the treatment of glioblastoma comprising the administration of a synergistic combination of benzodiapines such as BZD-1 and anticancer agents such as temozolomide, the prior art discloses where BZD-1 potentiates temozolomide. The present claim does not require treatment of a glioblastoma with a particular MGMT methylation status and one of skill in the art would have treated either a methylated or non-methylated glioblastoma.
Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function "would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art." 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991). See MPEP 2145, Section II. "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
As the prior art composition structure is identical to the presently claimed composition structure, both containing BZD-1 and temozolomide, the properties claimed are present in the prior art.
Therefore, the present claims are prima facie obvious.
Conclusion
Claims 1-14 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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/QUINCY A. MCKOY/
Patent Examiner
Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626