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 1-3,7-9, 12, 14-15, 17, 19-21, 23-27, 30 and 33 are pending and are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/06/2024, 1/16/2025 and 03/19/2025 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application claims the benefit of U.S. Patent Application Serial No. 63/187,726, filed on May 12, 2021.
Claim Objections
Claim 14 is objected to because of the following informalities: Claim 14 depends on the cancelled claim 13. Appropriate correction is required.
In the instant office action, Claim 14 will be examined being dependent on instant claim 1 for the purposes of compact prosecution. Applicant is however required to correct the dependency.
Claim Rejections - 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 7-9, 12, 14-15, 17, 19-21, 23-27, 30 and 33 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Nathanson et al. (US 2023/0040125, priority date 12/24/2019)
Instant claims are drawn to a method for treating a mammal having a central nervous system (CNS) cancer wherein said mammal has been previously treated for a CNS cancer, or treatment of a recurrent CNS cancer wherein said method comprises: administering an inhibitor of a B-cell lymphoma-extra large (Bcl-xL) polypeptide to said mammal; and administering a chemotherapeutic agent to said mammal.
Nathanson et al. discloses a method of treating a CNS cancer, glioblastoma (GBM), comprising conjointly administering to a subject in need thereof a BCL-xL inhibitor and a second therapy selected from an alkylating agent, irradiation, or an MCL-1 inhibitor (claim 1, Abstract [0007] [0026]).They disclose the method wherein subject has been diagnosed with glioblastoma multiforme. In some embodiments, the subject has been previously treated for glioblastoma with a prior treatment [0014]. Their methods ameliorate the symptoms of GBM. In some embodiments, the methods reduce the chances of tumor survival and/or recurrence [0026]. They disclose wherein the subject is human [0038]. Nathanson et al. disclose the Bcl-xL inhibitor in their invention to be selected from, , WEHI 539, ABT-263, ABT-199, ABT-737, sabutoclax, AT101, TW-37, APG-1252, A1155463, gambogic acid, any other Bcl-xL inhibitor, and combinations thereof [0021] and the chemotherapeutic agent to be selected from alkylating agents such as temozolomide other MCL-1 inhibitors or irradiation [0022-0025]. Nathanson et al. disclose that their combination when administered concurrently, the combination cancer therapies may be administered in a single formulation or in separate formulations, and if separately, then optionally, by different modes of administration [0073]. They disclose the treatment of subject who has been diagnosed with glioblastoma multiforme (this reads on the limitation wherein the patient has not been treated for CNS cancer for at least one month, recited in instant claim 17) [0029].
With regards to the limitation of wherein in the CNS cancer is recurrent, Nathanson et al. disclose CNS cancer glioblastoma which is well known in the art for being a recurrent cancer and further disclose that their methods ameliorate the symptoms of GBM. In some embodiments, the methods reduce the chances of tumor survival and/or recurrence [0026].
With regards to the limitation in the instant claims 8 and 26 which is that the Bcl-XL polypeptide inhibitor is an inhibitor of Bcl-XL polypeptide activity, this is the mechanistic and functional property of the inhibitors and would inherently be present in them. Since Nathanson et al. disclose the same inhibitors of Bcl-Xl instantly claimed, this functional property would be inherent to those inhibitors. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is also noted that, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430,433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims. In addition, it is also noted that “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990
Therefore the method disclosed by Nathanson et al. fully anticipates instant claims 1-3,7-9, 12, 14-15, 17, 19-21, 23-27, 30 and 33.
Claims 1-3, 7, 8, 14-15 19-21, 23-26 and 33 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Zhai et al (US 2020/0297743, referenced in instant IDS)
Instant claims are as stated above.
Zhai et al. discloses a method for treating a mammal having a central nervous system (CNS) cancer (abstract, a method of treating cancer, comprising administering to a subject in need thereof a therapeutically effective amount of a Bcl-2/Bcl-xL inhibitor alone or in combination with a therapeutically effective amount of a chemotherapeutic agent.), wherein said mammal has been previously treated for a CNS cancer (Claim 6, wherein the patient is relapsed from or refractory to a prior treatment.) and the prior treatment comprises surgery, chemotherapy, radio therapy, targeted therapy, immunotherapy, or any combination thereof [0063]. wherein said method comprises: administering an inhibitor of a B-cell lymphoma-extra large (Bcl-xL) polypeptide to said mammal (Claim 1, A method of treating a cancer in a patient in need thereof, comprising administering to the subject a Bcl-2/Bcl-xL inhibitor.; Claim 5, wherein the cancer is selected from brain cancer (e.g., glioma, astrocytoma, oligodendroglioma, ependymoma, meningioma, medulloblastoma, ganglioglioma, Schwannoma, or carniopharyngioma).); and administering a chemotherapeutic agent to said mammal (para [0044], the chemotherapeutic drug is selected from the group consisting of docetaxel, panobinostat, 5-fluorouracil, paclitaxel, cisplatin, irinotecan, topotecan, and etoposide.). They disclose wherein their method comprises identifying said mammal as having said CNS cancer (para [0003], Although normal cells have low expression levels of anti-apoptotic Bcl-2 and Bcl-xL proteins, these proteins are found to be highly overexpressed in many different types of human tumors and are implied in tumor development, progression and resistance to drugs.; [0184], the patient's cancer is diagnosed as Bcl-2/Bcl-xL and Bax positive ; Claim 5.). They disclose wherein said mammal is a human [0276]. They disclose wherein the Bcl-2/Bcl-xL inhibitor and the chemotherapeutic agent can be administered together as a single unit dose or separately as multiple unit doses [0206].
With regards to the limitation in the instant claims 8 and 26 which is that the Bcl-XL polypeptide inhibitor is an inhibitor of Bcl-XL polypeptide activity, this is the mechanistic and functional property of the inhibitors and would inherently be present in them. Since Zhai et al. disclose the same inhibitors of Bcl-Xl instantly claimed, this functional property would be inherent to those inhibitors. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is also noted that, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430,433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims. In addition, it is also noted that “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990
Therefore the method disclosed by Zhia et al. fully anticipates instant claims 1-3, 7, 8, 14-15 19-21, 23-26 and 33.
Conclusion
Claims 1-3,7-9, 12, 14-15, 17, 19-21, 23-27, 30 and 33.are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dierdre (Renee) Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVITHA M RAO/Primary Examiner, Art Unit 1691
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