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
Applicant’s response filed on 08/28/2025, wherein claim 1 has been amended, and claim 89 has been cancelled.
Note: Applicant elects breast cancer as the species.
Claims 1, 4, 6-8, 10-18, 20, 31-33 are examined herein on the merits so far as they read on the elected species.
Any rejection from the previous office action which is not restated herein, is withdrawn.
Note: In view of the art, species ovarian cancer, and colon cancer are also examined herein.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
1) Claim(s) 1, 4, 6, 7, 8, 10, 11, 12, 13, 14-16, 17, 18, 20, 31, 32, 33 are rejected under 35 U.S.C. 103 as being unpatentable over Soong (US 2017/0143737, PTO-1449).
Soong discloses a method of treating cancer in human comprising administering Compound A which is instant Compound I. See claims 4, 31, 32-35, 37, 39. Soong teaches that combination of olaparib (50 mg/kg) and Compound A (950 mg/kg) significantly inhibited tumor growth of BRCA2-deficient triple-negative breast cancer patient-derived xenograft (PDX) model (instant Specification teaches that mutation can be loss-of-function of the BRCA2 gene…see instant claim 17; para [0031]; [0147] where it is taught that BRCA2 mutation can be deletion of BRCA2 gene). See page 28, paras [0404]; see page 6, para [0086] FIG. 8A-8C wherein compound A treatment on chemokine expression in BRCA2 wild type and mutant PDX-derived breast cancer cells is taught. It is taught that Compound A inhibits cell proliferation of human Lymphoma cell lines. See page 27, para [0391]-[0392]; see Example 3, paras [0405]-[0409] for anticancer activity of Compound A on BRCA1 negative and BRCA1 positive human ovarian cancer cell lines i.e meets administration of compound A to a subject wherein the subject has BRCA2 mutation. Soong teaches that the methods described therein are useful for treating a human subject. See para [0072]; para [0115]. A dosage form therein can contain compound A or a salt thereof in an amount of 5 mg, 10 mg, ….or 500 mg. See para [0380]; para [0358], wherein an amount of 50 mg to 300 mg of compound A is taught. It is taught that depending on the patients’ condition and the intended therapeutic effect, the dosing frequency of compound A can be once a week, once every two weeks, one to four times per month. See para [0278]. It is taught that compound A can be administered intravenously. See paras [0288], [0372], [0377]. Soong teaches that Compound A is administered in an amount effective to selectively activate p53 proteins in cancer and/or tumor cells, which may lead to cell death or apoptosis; it is taught that activation of p53 protein may inhibit, alter, or reduce cell proliferation and/or induce cell apoptosis. See paras, [0088], [0371], [0353]. Soong teaches that the tetracyclic quinolone compounds can stabilize the DNA G-quadruplexes (G4s) in cancer cells and thereby induce synthetic lethality in cancer cells. See para [0003].
Soong does not explicitly teach administration of Compound A (950 mg/kg) to a breast cancer subject that has a PALB2 mutation as in instant claims 1, 10, 14-16, 18.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer Compound A (950 mg/kg) to a breast cancer human subject that has a PALB2 mutation as in instant claims 1, 10, 12, 14-16, 18, and BRCA2 mutation as in instant claims because 1) Soong discloses a method of treating cancer in human comprising administering Compound A which is instant Compound I; Soong discloses a method of treating or ameliorating cell proliferative disorder such as cancer in a human comprising administering Compound A (see claims 31-35, 39 of ‘737) which is instant Compound I; 2) Soong also teaches that combination of olaparib (50 mg/kg) and Compound A (950 mg/kg) significantly inhibited tumor growth of BRCA2-deficient triple-negative breast cancer patient-derived xenograft (PDX) model, and 3) Soong teaches that Compound A is administered in an amount effective to selectively activate p53 proteins in cancer and/or tumor cells, which may lead to cell death or apoptosis; it is taught that activation of p53 protein may inhibit, alter, or reduce cell proliferation and/or induce cell apoptosis; Soong teaches that the tetracyclic quinolone compounds can stabilize the DNA G-quadruplexes (G4s) in cancer cells and thereby induce synthetic lethality in cancer cells. One of ordinary skill in the art would have been motivated to administer Compound A (950 mg/kg) to a breast cancer human subject that has a PALB2 mutation as in instant claims 1, 10, 12, 14-16, 18, and BRCA2 mutation as in instant claims with reasonable expectation of success of treating breast cancer.
Soong does not explicitly teach administration of the amounts as in instant claims 18, 20.
Soong does not explicitly teach administration of the compound A in a 28-day cycle as in instant claims 32, 33.
It would have been obvious to a person of ordinary skill in the art to administer a dose as in instant claims 18, 20, to a subject such as human to treat breast cancer, ovarian cancer. It has been held that it is within the skill in the art to select optimal parameters, such as effective amounts of active agents to be administered, in order to achieve a beneficial effect. The amount of a specific dosage is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize, in order to achieve a beneficial effect. Soong teaches a dosage form therein can contain compound A or a salt thereof in an amount of 5 mg, 10 mg,.or 500 mg. See para [0380]; para [0358], wherein an amount of 50 mg to 300 mg of compound A is taught. Soong also teaches that combination of olaparib (50 mg/kg) and Compound A (950 mg/kg) significantly inhibited tumor growth of BRCA2-deficient triple-negative breast cancer patient-derived xenograft (PDX) model.
It would have been obvious to a person of ordinary skill in the art to administer compound A in a 28-day cycle as in instant claims 32, 33, to a subject such as human. One of ordinary skill in the art would have been motivated to administer compound A in a 28-day cycle as in instant claims 32, 33, with reasonable expectation of success of treating breast cancer, ovarian cancer. Soong teaches that depending on the patients’ condition and the intended therapeutic effect, the dosing frequency of compound A can be once a week, once every two weeks, one to four times per month. See para [0278].
The reference teaches that the dosage and administration period can be varied. Thus, the reference has recognized these parameters as variables, it would have been customary for an artisan of ordinary skill to determine the optimal dosage in order to best achieve the desired results.
Optimization of result effect parameters e.g., dosage range, dosing regimens, dosing duration is obvious as being within the skill of the artisan, involving merely routine skill in the art.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer Compound A (950 mg/kg) to a breast cancer human subject that has a PALB2 mutation as in instant claims, and BRCA2 mutation as in instant claims 4, 11, 17, because 1) Soong discloses a method of treating cancer in human comprising administering Compound A which is instant Compound I; Soong discloses a method of treating or ameliorating cell proliferative disorder such as cancer in a human comprising administering Compound A (see claims 31-35, 39 of ‘737) which is instant Compound I; and 2) Soong teaches that Compound A is administered in an amount effective to selectively activate p53 proteins in cancer and/or tumor cells, which may lead to cell death or apoptosis; it is taught that activation of p53 protein may inhibit, alter, or reduce cell proliferation and/or induce cell apoptosis; Soong teaches that the tetracyclic quinolone compounds can stabilize the DNA G-quadruplexes (G4s) in cancer cells and thereby induce synthetic lethality in cancer cells. One of ordinary skill in the art would have been motivated to administer Compound A (950 mg/kg) to a breast cancer human subject that has a PALB2 mutation as in instant claims and BRCA2 mutation as in instant claims 4, 11, 17 with reasonable expectation of success of treating breast cancer.
Response to Arguments
Note: The above rejection has been modified in view of Applicant’s amendment.
Applicant's arguments filed on 08/28/2025 have been fully considered, but they are not persuasive as discussed above and those found below.
Applicant argues that “Soong focuses on a combination with a PARP inhibitor and does not provide the requisite motivation to remove the PARP inhibitor and treat a patient with a cancer not taught in the prior art (cancers with PALB2 mutation) with Compound I as a single active agent”. Applicant’s arguments have been considered, but not found persuasive. Soong discloses a method of treating cancer in human comprising administering Compound A which is instant Compound I; and Soong teaches that Compound A is administered in an amount effective to selectively activate p53 proteins in cancer and/or tumor cells, which may lead to cell death or apoptosis; it is taught that activation of p53 protein may inhibit, alter, or reduce cell proliferation and/or induce cell apoptosis; Soong teaches that the tetracyclic quinolone compounds can stabilize the DNA G-quadruplexes (G4s) in cancer cells and thereby induce synthetic lethality in cancer cells. One of ordinary skill in the art would have been motivated to administer Compound A (950 mg/kg) to a breast cancer human subject that has a PALB2 mutation as in instant claims 1, 10, 12, 14-16, 18, and BRCA2 mutation as in instant claims with reasonable expectation of success of treating breast cancer because 1) Soong discloses a method of treating cancer in human comprising administering Compound A which is instant Compound I, and 2) Soong teaches that Compound A is administered in an amount effective to selectively activate p53 proteins in cancer and/or tumor cells, which may lead to cell death or apoptosis; it is taught that activation of p53 protein may inhibit, alter, or reduce cell proliferation and/or induce cell apoptosis; Soong teaches that the tetracyclic quinolone compounds can stabilize the DNA G-quadruplexes (G4s) in cancer cells and thereby induce synthetic lethality in cancer cells.
Applicant argues that “Soong is entirely silent regarding PALB2 mutations, and provides no evidence or suggestion that PALB2 mutation cancers could be treated with a single active agent - Compound I”. Applicant’s arguments have been considered, but not found persuasive. Soong discloses a method of treating cancer in human comprising administering Compound A which is instant Compound I. Soong discloses a method of treating or ameliorating cell proliferative disorder such as cancer in a human comprising administering Compound A (see claims 31-35, 39 of ‘737) which is instant Compound I. Soong teaches that Compound A is administered in an amount effective to selectively activate p53 proteins in cancer and/or tumor cells, which may lead to cell death or apoptosis; it is taught that activation of p53 protein may inhibit, alter, or reduce cell proliferation and/or induce cell apoptosis; Soong teaches that the tetracyclic quinolone compounds can stabilize the DNA G-quadruplexes (G4s) in cancer cells and thereby induce synthetic lethality in cancer cells. One of ordinary skill in the art would have been motivated to administer Compound A (950 mg/kg) to a breast cancer human subject that has a PALB2 mutation as in instant claims 1, 10, 12, 14-16, 18, and BRCA2 mutation as in instant claims with reasonable expectation of success of treating breast cancer because 1) Soong discloses a method of treating cancer in human comprising administering Compound A which is instant Compound I, and 2) Soong teaches that Compound A is administered in an amount effective to selectively activate p53 proteins in cancer and/or tumor cells, which may lead to cell death or apoptosis; it is taught that activation of p53 protein may inhibit, alter, or reduce cell proliferation and/or induce cell apoptosis; Soong teaches that the tetracyclic quinolone compounds can stabilize the DNA G-quadruplexes (G4s) in cancer cells and thereby induce synthetic lethality in cancer cells.
Applicant argues that “there is no indication in Soong how the dosing of Compound I should be changed from Soong when the subjects harbor different cancer profiles (a PALB2 mutation)”. Applicant’s arguments have been considered. It would have been obvious to a person of ordinary skill in the art to administer a dose as in instant claims 18, 20, to a subject such as human to treat breast cancer, ovarian cancer. It has been held that it is within the skill in the art to select optimal parameters, such as effective amounts of active agents to be administered, in order to achieve a beneficial effect. The amount of a specific dosage is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize, in order to achieve a beneficial effect. Soong teaches a dosage form therein can contain compound A or a salt thereof in an amount of 5 mg, 10 mg,.or 500 mg. See para [0380]; para [0358], wherein an amount of 50 mg to 300 mg of compound A is taught. The reference teaches that the dosage and administration period can be varied. Thus, the reference has recognized these parameters as variables, it would have been customary for an artisan of ordinary skill to determine the optimal dosage in order to best achieve the desired results.
It is pointed out that instant claims 1, 18 recite treating any cancer in a human wherein the human has PALB2 mutation; and administering any amount of compound in claim 1; claim 18 recites a dose ranging from about 50 mg to about 650 mg of compound I per body surface area of the human body. The data in the specification para [0287] states that one patient (not clear if the patient is a breast cancer patient) enrolled who harbored PALB2 mutation and BRCA2 mutation showed partial response when given 650 mg/m2 of Compound I. Also see Figures 7 and 9. This data does not give rise to statistically significant data having regard to the response rate, as they refer to one single patient only. Further, the data in the Declaration is for pancreatic cancer with PALB2 germline variant (pathogenic) TP53 (pathogenic) employing 475 mg/m2 of Compound I. Further, instant claims recite that the human has BRCA2 mutations. Moreover, the causal link between an effective/ improved treatment with the claimed compound and PALB2 mutations is currently not established nor exist any experimental data with this respect. As discussed above the data is for a particular cancer employing particular amounts, and any results have to be commensurate in scope with instant claims. Soong discloses a method of treating or ameliorating cell proliferative disorder such as cancer in a human comprising administering Compound A (see claims 31-35, 39 of ‘737) which is instant Compound I. Soong teaches that Compound A is administered in an amount effective to selectively activate p53 proteins in cancer and/or tumor cells, which may lead to cell death or apoptosis; it is taught that activation of p53 protein may inhibit, alter, or reduce cell proliferation and/or induce cell apoptosis; Soong teaches that the tetracyclic quinolone compounds can stabilize the DNA G-quadruplexes (G4s) in cancer cells and thereby induce synthetic lethality in cancer cells. Soong renders obvious instant claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
1) Claims 1, 4, 6, 7, 8,10-18, 20, 31-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-25 of US Patent: 11,524,012 (US Application: 17/394,541). Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims are drawn to a method of treating cancer in a subject comprising administering a therapeutically effective amount of compound I or a salt or solvate thereof where the subject has a PALB2 mutation and a BRCA2 mutation; drawn to method of treating cancer in a subject comprising administering a pharmaceutical composition comprising compound I or a salt or solvate thereof and a carrier or excipient at a dose of about 50 mg to about 650 mg (as in instant claim 35) where the subject has a PALB2 mutation and a BRCA2 mutation; and wherein the PALB2 mutation is a germline mutation and/or a somatic mutation. Claims of ‘012 are drawn to a method of treating cancer in a subject comprising administering a therapeutically effective amount of a composition comprising N-oxide of compound I or a salt thereof, wherein the cancer is A BRCA2 mutant or BRCA2 deficient cancer.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer compound I to a breast cancer subject that has a PALB2 mutation and BRCA2 gene mutation as in instant claims because 1) 541 teaches N-oxide of Compound I is administered to a subject to treat cancer, 2) ‘541 teaches N-oxide of Compound I is administered to a subject to treat cancer wherein cancer is a BRCA2. One of ordinary skill in the art would have been motivated to administer compound I to a breast cancer subject that has a PALB2 mutation and BRCA2 gene mutation as in instant claims with reasonable expectation of success of treating breast cancer.
‘012 does not explicitly teach administration of the amounts as in instant claims 18, 20.
‘012 does not explicitly teach administration of the compound A in a 28-day cycle as in instant claims 32, 33.
It would have been obvious to a person of ordinary skill in the art to administer a dose as in instant claims 18, 20 to a subject such as human. It has been held that it is within the skill in the art to select optimal parameters, such as effective amounts of active agents to be administered, in order to achieve a beneficial effect. The amount of a specific dosage is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize, in order to achieve a beneficial effect.
It would have been obvious to a person of ordinary skill in the art to administer compound A in a 28-day cycle as in instant claims 32, 33 to a subject such as human. One of ordinary skill in the art would have been motivated to administer compound A in a 28-day cycle as in instant claims 32, 33 with reasonable expectation of success of treating breast cancer.
Optimization of result effect parameters e.g., dosage range, dosing regimens, dosing duration is obvious as being within the skill of the artisan, involving merely routine skill in the art.
Response to Arguments
Applicant’s arguments have been considered, but not found persuasive for the same reasons as described above in response to the obviousness rejection, which are expressly incorporated by reference herein.
One of ordinary skill in the art would have been motivated to administer compound I to a breast cancer subject that has a PALB2 mutation and BRCA2 gene mutation as in instant claims with reasonable expectation of success of treating breast cancer because 1) 541 teaches N-oxide of Compound I is administered to a subject to treat cancer, 2) ‘541 teaches N-oxide of Compound I is administered to a subject to treat cancer wherein cancer is a BRCA2. It is pointed out that N-oxide of Compound I is structurally similar to instant Compound I. It would be obvious to employ Compound I, since ‘541 teaches N-oxide of Compound I is administered to a subject to treat cancer wherein cancer is a BRCA2.
2) Claims 1, 4, 6, 7, 8,10-18, 20, 31-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55, 58-68, of copending Application No. 17/034,578 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims are drawn to a method of treating cancer in a subject comprising administering a therapeutically effective amount of compound I or a salt or solvate thereof where the subject has a PALB2 mutation and a BRCA2 mutation; drawn to method of treating cancer in a subject comprising administering a pharmaceutical composition comprising compound I or a salt or solvate thereof and a carrier or excipient at a dose of about 50 mg to about 650 mg (as in instant claim 18) where the subject has a PALB2 mutation and a BRCA2 mutation; and wherein the PALB2 mutation is a germline mutation and/or a somatic mutation. Claims of ‘578 are drawn to a method of treating cancer in a subject comprising administering a therapeutically effective amount of compound A (instant compound I) or a salt or solvate thereof; and at least one agent that induces immune checkpoint blockade
‘578 does not explicitly teach administration of the amounts as in instant claims 18, 20.
‘578 does not explicitly teach administration of the compound A or a composition comprising compound A in a 28-day cycle as in instant claims 32, 33.
It would have been obvious to a person of ordinary skill in the art to administer a dose as in instant claims 18, 20. It has been held that it is within the skill in the art to select optimal parameters, such as effective amounts of active agents to be administered, in order to achieve a beneficial effect. The amount of a specific dosage is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize, in order to achieve a beneficial effect.
It would have been obvious to a person of ordinary skill in the art to administer compound A in a 28-day cycle as in instant claims 32, 33 to a subject such as human. One of ordinary skill in the art would have been motivated to administer compound A in a 28-day cycle as in instant claims 32, 33 with reasonable expectation of success of treating breast cancer.
Optimization of result effect parameters e.g., dosage range, dosing regimens, dosing duration is obvious as being within the skill of the artisan, involving merely routine skill in the art.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer compound I to a breast cancer subject that has a PALB2 mutation and BRCA2 gene mutation as in instant claims 1, 4, 10, 11, 14-18 because 1) because ‘578 teaches Compound A (instant compound I) is administered to a subject to treat cancer, and 2) ‘578 teaches Compound A (instant compound I) is administered to a subject to treat cancer wherein cancer is a BRCA2 mutated cancer. One of ordinary skill in the art would have been motivated to administer compound A to a breast cancer subject that has a PALB2 mutation and/or BRCA2 gene mutation as in instant claims with reasonable expectation of success of treating breast cancer.
It would have been obvious to a person of ordinary skill in the art to administer compound A or a salt thereof intravenously, since intravenous administration of anti-cancer agents is well known.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments have been considered, but not found persuasive. It is pointed out that claims 55, 58-68, are still present in the co-pending Application No. 17/034,578 (reference application).
3) Claims 1, 4, 6, 7, 8,10-18, 20, 31-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,229,654. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims are drawn to a method of treating cancer in a subject comprising administering a therapeutically effective amount of compound I or a salt or solvate thereof where the subject has a PALB2 mutation and a BRCA2 mutation; drawn to method of treating cancer in a subject comprising administering a pharmaceutical composition comprising compound I or a salt or solvate thereof and a carrier or excipient at a dose of about 50 mg to about 650 mg (as in instant claim 18) where the subject has a PALB2 mutation and a BRCA2 mutation; and wherein the PALB2 mutation is a germline mutation and/or a somatic mutation. Claims of ‘654 are drawn to a method of treating ameliorating a BRCA1 and/or BRCA2-deficient cancer in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of Compound A (instant compound I) pharmaceutically acceptable salt thereof, wherein the BRCA1 and/or BRCA2-deficient cancer is selected from the group consisting of breast and ovarian cancer.
‘654 does not explicitly teach administration of the amounts as in instant claims 18, 20.
‘654 does not explicitly teach administration of the compound A or a composition comprising compound A in a 28-day cycle as in instant claims 32, 33.
It would have been obvious to a person of ordinary skill in the art to administer a dose as in instant claims 18, 20 to a subject such as human. It has been held that it is within the skill in the art to select optimal parameters, such as effective amounts of active agents to be administered, in order to achieve a beneficial effect. The amount of a specific dosage is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize, in order to achieve a beneficial effect.
It would have been obvious to a person of ordinary skill in the art to administer compound A in a 28-day cycle as in instant claims 32, 33 to a subject such as human. One of ordinary skill in the art would have been motivated to administer compound A in a 28-day cycle as in instant claims 32, 33 with reasonable expectation of success of treating breast cancer.
Optimization of result effect parameters e.g., dosage range, dosing regimens, dosing duration is obvious as being within the skill of the artisan, involving merely routine skill in the art.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer compound A to a breast cancer subject that has a PALB2 mutation and BRCA2 gene mutation as in instant claims because 1) ‘654 teaches Compound A (instant compound I) is administered to a subject to treat cancer, and 2) ‘654 teaches Compound A (instant compound I) is administered to a subject to treat cancer wherein cancer is a BRCA2 mutated cancer. One of ordinary skill in the art would have been motivated to administer compound A to a breast cancer subject that has a PALB2 mutation and/or BRCA2 gene mutation as in instant claims with reasonable expectation of success of treating breast cancer.
It would have been obvious to a person of ordinary skill in the art to administer compound I or a salt thereof intravenously, since intravenous administration of anti-cancer agents is well known.
Response to Arguments
Applicant’s arguments have been considered, but not found persuasive.
Claims of ‘654 are drawn to a method of treating ameliorating a BRCA1 and/or BRCA2-deficient cancer in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of Compound A (instant compound I) pharmaceutically acceptable salt thereof, wherein the BRCA1 and/or BRCA2-deficient cancer is selected from the group consisting of breast and ovarian cancer. See claims 1-2, 5-8.
One of ordinary skill in the art would have been motivated to administer compound A to a breast cancer subject that has a PALB2 mutation and/or BRCA2 gene mutation as in instant claims with reasonable expectation of success of treating breast cancer because 1) ‘654 teaches Compound A (instant compound I) is administered to a subject to treat cancer, and 2) ‘654 teaches Compound A (instant compound I) is administered to a subject to treat cancer wherein cancer is a BRCA2 mutated cancer.
Prior Art of Record:
WO2020/051342;
US 8,853,234; compound A2;
WO2017105382A1, claims 71, 75, 76 or US 20170166590 (used); crystalline forms, cancer treatment taught, BRCA2;
WO 2019/168688 or US 20190374550 (used);
SOURCE: International Journal of Molecular Sciences (2017), 18(1), 210/1-210/17 CODEN: IJMCFK; ISSN: 1422-0067; Recent evidence demonstrated the efficacy of targeting ribosome biogenesis with the specific inhibitor of rRNA synthesis, CX-5461 has now progressed to a phase I clin. trial in patients with haematol. malignancies and phase I/II trial in breast cancer.
Drygin et al., Cancer Res; 71(4) February 15, 2011; In vivo antitumor activity of CX-5461 The antitumor activity of CX-5461 was evaluated in two murine xenograft models of human cancers, pancreatic carcinoma (MIA PaCa-2) and melanoma (A375). In these xenograft models, CX-5461 was administered orally (50 mg/kg) either once daily or every 3 days.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shobha Kantamneni, Ph.D whose telephone number is 571-272-2930. The examiner can normally be reached on Monday-Friday, 8am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Kortney Klinkel, Ph.D can be reached on 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHOBHA KANTAMNENI/Primary Examiner, Art Unit 1627