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 1-37 are pending and are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/03/2025 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 is a National Stage Application under 35 U.S.C. §371 and claims the benefit of International Application No. PCT/US2023/062661, filed February 15, 2023, which claims priority to U.S. Provisional Application No. 63/268,051, filed February 15, 2022, and U.S. Provisional Application No. 63/426,589, filed November 18, 2022
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 1-2, 9-19, 21, 26-28 and 30-32 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Mcgurk et al. (WO2019/152989) (referenced in IDS dated 04/03/2025).
Instant claims are drawn to a method of treating primary or metastatic brain cancer in a human subject in need thereof, the method comprising administering to the human subject an effective dose of niraparib, or a pharmaceutically acceptable salt thereof.
Mcgurk et al. discloses methods of treating cancer in pediatric subjects comprising administering Niraparib in a suitable oral dosage for optionally in combination with a second therapeutic agent (abstract) (claim 1). They disclose wherein the cancer is a CNS cancers such as brain cancer which includes glioblastoma multiforme, gliosarcoma, astrocytoma, glioblastoma, medulloblastoma glioma etc. [0029][0218-0235], claims 44. 46 and 47-49). They disclose wherein the subjects has previously received at least one more line of treatment [0040]. They disclose that the subject was previously treated with a chemotherapy which is platinum based and wherein the human subject had a complete or partial response to the chemotherapy (embodiment 126-129) and the mean peak plasma concentration of niraparib is 600-100 ng/ ml (embodiment 130). They disclose their wherein about 60%, 65%, 70%, 75%, 80%, 85% or 90% of the niraparib is bound to human plasma protein of the subject after the administering.(embodiment 132). They disclose that niraparib is administered as niraparib tosylate monohydrate [0069]. They disclose method further comprises administering one or more of surgery, a radiotherapy, a chemotherapy, an immunotherapy, an anti-angiogenic agent, or an anti-inflammatory (claim 7). They further disclose wherein the daily orally administered amount of niraparib is a flat dose of 200 mg to 300mg/m2 of free base (Claim 70-77 and claim 90). The niraparib is administer in the form of a capsule or a tablet or liquid formulation [0052-0062], (claims 80, 88). They disclose embodiments where in the cancer is characterized by homologous recombination deficiency (HRD) [0169]
With regards to the limitations of the claims 18-19, 21, 26-27, these are functional properties of the niraparib drug and composition which would occur when administered as in the case of McGurk et al. these functional limitations are therefore inherent to the niraparib compositions and would occur in the methos of McGurk et al. 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 McGurk et al. fully anticipates instant claims 1-2, 9-19, 21 and 26-28.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-37 are rejected under 35 U.S.C. 103(a) as being unpatentable over by Mcgurk et al. (WO2019/152989) as applied to claims 1-2, 9-19, 21 and 26-28 above in view of Sanai (Clinical trial NCT05076513, 2021-2023), Merck sharp (Clinical trail NCT01294735, 2011-2012) and Zhang et al (Case report, frontiers in Onclology, April 2022, page 1-6 )(all referenced in IDS dated 04/03/2025)
Instant claims are drawn to a method of treating primary or metastatic brain cancer in a human subject in need thereof, the method comprising administering to the human subject an effective dose of niraparib, or a pharmaceutically acceptable salt thereof.
Mcgurk et al. discloses methods of treating cancer in pediatric subjects comprising administering Niraparib in a suitable oral dosage for optionally in combination with a second therapeutic agent (abstract) (claim 1). They disclose wherein the cancer is a CNS cancers such as brain cancer which includes glioblastoma multiforme, gliosarcoma, astrocytoma, glioblastoma, medulloblastoma glioma etc. [0029][0218-0235], claims 44. 46 and 47-49). They disclose wherein the subjects has previously received at least one more line of treatment [0040]. They disclose that the subject was previously treated with a chemotherapy which is platinum based and wherein the human subject had a complete or partial response to the chemotherapy (embodiment 126-129) and the mean peak plasma concentration of niraparib is 600-100 ng/ ml (embodiment 130). They disclose their wherein about 60%, 65%, 70%, 75%, 80%, 85% or 90% of the niraparib is bound to human plasma protein of the subject after the administering.(embodiment 132). They disclose that niraparib is administered as niraparib tosylate monohydrate [0069]. They disclose method further comprises administering one or more of surgery, a radiotherapy, a chemotherapy, an immunotherapy, an anti-angiogenic agent, or an anti-inflammatory (claim 7). They further disclose wherein the daily orally administered amount of niraparib is a flat dose of 200 mg to 300mg/m2 of free base (Claim 70-77 and claim 90). The niraparib is administer in the form of a capsule or a tablet or liquid formulation [0052-0062], (claims 80, 88). ], (claims 80, 88). They disclose embodiments where in the cancer is characterized by homologous recombination deficiency (HRD) [0169]
With regards to the limitations of the claims 18-19, 21, 26-27, these are functional properties of the niraparib drug and composition which would occur when administered as in the case of McGurk et al. these functional limitations are therefore inherent to the niraparib compositions and would occur in the methos of McGurk et al. 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).
McGurk et al. fails to provide specific indications of treatment regarding for example the tumor profile, the co-administered radiotherapy dosage, he duration of the treatment, the monitoring of experimental parameters such as the unbound concentration niraparib and particular active agents for combined treatment.
With regards to claim 20 and 22-25 McGurk provides a person of ordinary skill in the art to measure the pharmacokinetics of Niraparib including the concentrations of the unbound niraparib in the tumor section absence of evidence to the contrary.
However, Sanai disclose ongoing clinical study testing the use of niraparib in combination with radiation therapy to treat patient with glioblastoma and recurrent glioma. Patients diagnosed with glioblastoma will be treated with niraparib for 4 days prior to surgical resection. And for therapeutic expansion phase patients will receive niraparib in combination with radiation or as monotherapy. Following radiotherapy, eligible participants may receive niraparib maintenance treatment ( see page 3/11).
Merck Sharp disclose a study of the safety and efficacy of Niraparib with Temozolamide in participants with advanced cancer.
Zhang et al. discloses treatment of brain metastases from ovarian cancer with PARP inhibitors as a single agent (abstract). They recommend PARPi for maintenance in platinum-sensitive recurrent ovarian cancer and discloses that using niraparib as a monotherapy they say a considerable clinical response in patient with brain metastases.
With regards to claims 3-8 the type of brain cancer tumor treated with niraparib and radiotherapy, with motivations from McGurk et al. and Sanai, it will be well within the purview of a person of ordinary skill in the oncology art to arrive at the most optimal regiment for the treatment protocol including the dosage of the radiation, duration of treatment and inclusion of maintenance treatment, absence of the evidence to the contrary.
With regards to claims 29-Merck Sharp provides motivation to combine niraprib with temozolomide in treatment of cancer.
With regards to claims 35-37, all PARP inhibitors function similarly, as taught by McGruk et al. they all act by blocking DNA repair in the context of cancer cells with he BRCA mutation, PARP inhibition resuls in synthetic lethality and therefore germline mutations show marked clinical benefic that follows treatment with PARP inhibitor [0005] As such it would have been obvious to a person of ordinary skill in the art to use any of the known PARP inhibitors along with Niraparib in brain cancer treatment, absence of evidence to the contrary. Treatment of brain cancer with niraparib is well known in the art. As such a person of ordinary skill in the art would be imbued with a reasonable expectation of success in treating all types of breast cancer with the instantly claimed compound, absence of evidence to the contrary.
Conclusion
Claims 1-37 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAVITHA M RAO/Primary Examiner, Art Unit 1691
Prosecution Insights