Detailed Action
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 .
Election/Restrictions
The examiner acknowledges that the "the technical feature of dihydromyricetin" is not found in the claims.
Regarding the election of species requirement, Applicant elected, without traverse, the
following species for examination:
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Applicant's election without traverse of the above species requirement in the reply filed on 6 June 2026 is acknowledged. However, in the election of species requirement has been withdrawn.
Status of Claims
Claims 1-17 are pending.
Priority
The instant application claims priority as follows:
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Information Disclosure Statement
All references from the IDS(s) received 12/10/2025, 10/27/2025, 10/21/2025 and 12/06/2024 have been considered unless marked with a strikethrough.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites, in part, that “the OS is least about 12 months with a 95% confidence interval (95% CI)”. It appears that Applicant intended to include the word “at” between “is” and “least” in the quoted text. Appropriate correction is required.
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.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (Annals of Oncology, Volume 30, Supplement 5, v844-v845, October 2019).
Smith et al. teach that “GALAHAD is an ongoing open-label phase II study assessing niraparib (300 mg daily) in pts with mCRPC and DRD with disease progression on taxane and androgen receptor-targeted therapy.” Smith et al. teach that, in the GALAHAD trial, the “DRD status [of the test subjects] was evaluated by a plasma or tissue based test and defined as having biallelic alterations in BRCA1/2 (BRCA), ATM, FANCA, PALB2, CHEK2, BRIP1, or HDAC2.”
With regard to claim 1, Smith et al. teach: A method of improving the median overall survival (OS) in a male human with metastatic castration-resistant prostate cancer (mCRPC) with biallelic DNA-repair anomalies, wherein said biallelic DNA-repair anomalies are selected from: i) BRCA1, BRCA2, or a combination thereof, ii) ATM, FANCA, PALB2, CHEK2, BRIP1, HDAC2, or any combination thereof; or iii) any combination thereof; and wherein the male human has received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy, the method comprising administering to such male human a once-daily oral dosing of 300 mg niraparib.
With regard to claim 2, Smith et al. teach a method of improving OS of claim 1, wherein the male human has BRCA DNA-repair anomalies and the median OS is about 13 months
(95% CI).
With regard to claim 3, Smith et al. teach a method of improving OS of claim 1, wherein the male human has DNA-repair anomalies selected from ATM, FANCA, PALB2, CHEK2, BRIP1, HDAC2, or any combination thereof, and the median OS is about 10 months (95% CI).
With regard to claim 4, Smith et al. teach a method of improving OS of claim 1, wherein there is a radiographic progression-free survival (rPFS) of about 5.6 months (95% CI).
With regard to claim 5, Smith et al. teach a method of improving OS of claim 4, wherein the male human has BRCA DNA-repair anomalies and the rPFS is about 8.1 months (95% CI).
With regard to claim 6, Smith et al. teach a method of improving OS of claim 1, wherein the male human has BRCA DNA-repair anomalies and the improved efficacy is an objective response rate (ORR) of about 34.2% (95% CI).
With regard to claim 7, Smith et al. teach a method of improving OS of claim 1, wherein there is a median duration of objective response of about 5.55 months (95% CI).
With regard to claim 8, Smith et al. teach a method of improving OS of claim 1, wherein there is median time to radiographic progression of about 5.8 months (95% CI).
With regard to claim 9, Smith et al. teach a method of improving OS of claim 8, wherein the male human has BRCA DNA-repair anomalies and the median time to radiographic progression is about 8.08 months (95% CI).
With regard to claim 10, Smith et al. teach a method of improving OS of claim 1, wherein there is a median time to PSA progression of about 4.6 months (95% CI).
With regard to claim 11, Smith et al. teach a method of improving OS of claim 1, wherein there is a median time to symptomatic skeletal event of about 13 months (95% CI).
With regard to claim 12, Smith et al. teach a method of improving OS of claim 1, wherein there is a circulating tumor cells (CTC) response rate of about 18% (95% CI).
With regard to claim 13, Smith et al. teach a method of improving OS of claim 12, wherein the male human has BRCA DNA-repair anomalies and the CTC response rate is about 24% (95% CI).
With regard to claim 14, Smith et al. teach a method of improving OS of claim 12, wherein the male human has DNA-repair anomalies selected from ATM, FANCA, PALB2, CHEK2, BRIP1, HDAC2, or any combination thereof, and the CTC response rate is about 9% (95% CI).
An unrecited limitation is present so long as it is "necessarily present, or inherent, in the single anticipating reference." See Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003). Anticipation requires only an enabling disclosure, not actual creation or reduction to practice. See In re Montgomery, 677 F.3d 1375, 1380 (Fed. Cir. 2012). Here, to the extent that a statistical outcomes of a clinical trial population is not explicitly recited in Smith et al., the reference nonetheless inherently anticipate the claims because it discloses in an enabling manner of administering niraparib at 300 mg/daily to a male human with metastatic castration-resistant prostate cancer (mCRPC) and with biallelic DNA-repair anomalies selected from BRCA1, BRCA2, ATM, FANCA, PALB2, CHEK2, BRIP1, HDAC2.
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 framework for the objective analysis for determining obviousness under 35 U.S.C. 103 is stated in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Obviousness is a question of law based on underlying factual inquiries. The factual inquiries enunciated by the Supreme Court in Graham are summarized as follows:
(A) Determining the scope and content of the prior art;
(B) Ascertaining the differences between the claimed invention and the prior art; and
(C) Resolving the level of ordinary skill in the pertinent art.
Objective evidence relevant to the issue of obviousness must be evaluated by Office personnel. Id. at 17-18, 148 USPQ at 467. The evidence may be included in the specification as filed, accompany the application on filing, or be provided in a timely manner at some other point during the prosecution. The weight to be given any objective evidence is determined on a case-by-case basis. The mere fact that an applicant has presented evidence does not mean that the evidence is dispositive of the issue of obviousness.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation (TSM) in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
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.
Rejections under 35 USC § 103
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over by Smith et al. (Annals of Oncology, Volume 30, Supplement 5, v844-v845, October 2019) in view of Adashek et al. (Clin Genitourin Cancer. 2020 May 11;18(6):425–428)
As discussed above, Smith et al. teach: A method of improving the median overall survival (OS) in a male human with metastatic castration-resistant prostate cancer (mCRPC) with biallelic DNA-repair anomalies, wherein said biallelic DNA-repair anomalies are selected from: i) BRCA1, BRCA2, or a combination thereof, ii) ATM, FANCA, PALB2, CHEK2, BRIP1, HDAC2, or any combination thereof; or iii) any combination thereof; and wherein the male human has received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy, the method comprising administering to such male human a once-daily oral dosing of 300 mg niraparib.
Smith et al. do not (a) expressly provide a listing of pretreatments with various taxane-based chemotherapies, such docetaxel, paclitaxel, or cabazitaxel, qualifying for inclusion in the study; or (b) expressly provide a listing of pretreatments with various AR-targeted therapies, such as enzalutamide and apalutamide, qualifying for inclusion in the study.
Adashek et al. review recent randomized trials investigating androgen receptor inhibitors, such as enzalutamide and apalutamide, combined with docetaxel for treatment of mCSPC prostate cancer. See Table 1.
At the time that the application was filed, it would have been obvious to include the AR-targeted therapies and taxane-based chemotherapy reviewed by Adashek et al. among those pretreatments qualifying for inclusion in the study. A study investigator would have been motivated to do so in an effort to expand the pretreatment qualifying for inclusion in the study to include drugs reported to be effective for some prostate cancer patients, and would have had a reasonable expectation that inclusion would be successful.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over by Smith et al. (Annals of Oncology, Volume 30, Supplement 5, v844-v845, October 2019) in view of Wu et al. (US20200017462A1; published 2020-01-16).
As discussed above, Smith et al. teach: A method of improving the median overall survival (OS) in a male human with metastatic castration-resistant prostate cancer (mCRPC) with biallelic DNA-repair anomalies, wherein said biallelic DNA-repair anomalies are selected from: i) BRCA1, BRCA2, or a combination thereof, ii) ATM, FANCA, PALB2, CHEK2, BRIP1, HDAC2, or any combination thereof; or iii) any combination thereof; and wherein the male human has received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy, the method comprising administering to such male human a once-daily oral dosing of 300 mg niraparib.
Smith et al. do not expressly identify which particular salt form was used in study.
Wu et al. teach that the “Each ZEJULATM capsule contains 100 mg of niraparib (as tosylate monohydrate).” See paragraph [0053].
At the time that the application was filed, it would have been obvious to include tosylate monohydrate among the dosage forms suitable for the study. The tosylate monohydrate is available as the marketed drug ZEJULATM, and so an investigator would have been motivated to employ the tosylate monohydrate forms because it is commercially available and approved by the FDA. An investigator would have had a reasonable expectation of success when using a drug that is commercially available and approved by the FDA.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
US Patent No. 11,207,311
Claims 1, 3, 7, 8, 10, 11, 12 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,207,311 (reference patent) in view of Smith et al. (Annals of Oncology, Volume 30, Supplement 5, v844-v845, October 2019).
Claim 1 of the reference patent recites: A method of treating prostate cancer in a human in need of such treatment comprising administering to the human a safe and effective amount of niraparib or a salt thereof, wherein the prostate cancer is antiandrogen resistant and wherein the human (a) is not BRCA deficient or (b) is carrying at least one DNA repair anomaly selected from the group consisting of FANCA, PALB2, CHEK2, BRIP1, HDAC2, and ATM.
With regard to claims 1, 3, 7, 8, 10, 11, 12 and 14, Smith et al. teach: A method of improving the median overall survival (OS) in a male human with metastatic castration-resistant prostate cancer (mCRPC) with biallelic DNA-repair anomalies, wherein said biallelic DNA-repair anomalies are selected from: i) BRCA1, BRCA2, or a combination thereof, ii) ATM, FANCA, PALB2, CHEK2, BRIP1, HDAC2, or any combination thereof; or iii) any combination thereof; and wherein the male human has received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy, the method comprising administering to such male human a once-daily oral dosing of 300 mg niraparib.
The teachings of Smith et al. would have led one of ordinary skill to modify Claim 1 of the reference patent to arrive at the invention of claims 1, 3, 7, 8, 10, 11, 12 and 14 of the instant application. Motivation to do so, and a reasonable expectation of success, is provided by Smith et al. who teach successful clinical outcomes.
Therefore, 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.
US Patent No. 11,986,470
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,207,311 (reference patent) in view of Smith et al. (Annals of Oncology, Volume 30, Supplement 5, v844-v845, October 2019).
Claim 1 of the reference patent recites: A method of treating metastatic castration-sensitive prostate cancer in a human in need of such treatment comprising administering to the human a pharmaceutically acceptable amount of niraparib or a salt thereof, wherein the human is carrying at least one DNA repair anomaly in a gene selected from the group consisting of BRCA-1, BRCA-2, FANCA, PALB2, CHEK2, and BRIP1.
With regard to claims 1-14, Smith et al. teach: A method of improving the median overall survival (OS) in a male human with metastatic castration-resistant prostate cancer (mCRPC) with biallelic DNA-repair anomalies, wherein said biallelic DNA-repair anomalies are selected from: i) BRCA1, BRCA2, or a combination thereof, ii) ATM, FANCA, PALB2, CHEK2, BRIP1, HDAC2, or any combination thereof; or iii) any combination thereof; and wherein the male human has received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy, the method comprising administering to such male human a once-daily oral dosing of 300 mg niraparib.
The teachings of Smith et al. would have led one of ordinary skill to modify Claim 1 of the reference patent to arrive at the invention of claims 1-14 of the instant application. Motivation to do so, and a reasonable expectation of success, is provided by Smith et al. who teach successful clinical outcomes.
Therefore, 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.
US Patent No. 11,986,469
Claims 1, 3, 7, 8, 10, 11, 12 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,986,469 (reference patent) in view of Smith et al. (Annals of Oncology, Volume 30, Supplement 5, v844-v845, October 2019).
Claim 1 of the reference patent recites: A method of treating prostate cancer in a human in need of such treatment comprising administering to the human a pharmaceutically acceptable amount of niraparib or a salt thereof, wherein the prostate cancer is antiandrogen resistant and wherein the human (a) is not BRCA deficient or (b) is carrying at least one DNA repair anomaly in a gene selected from the group consisting of FANCA, PALB2, CHEK2, BRIP1, HDAC2, and ATM.
With regard to claims 1, 3, 7, 8, 10, 11, 12 and 14, Smith et al. teach: A method of improving the median overall survival (OS) in a male human with metastatic castration-resistant prostate cancer (mCRPC) with biallelic DNA-repair anomalies, wherein said biallelic DNA-repair anomalies are selected from: i) BRCA1, BRCA2, or a combination thereof, ii) ATM, FANCA, PALB2, CHEK2, BRIP1, HDAC2, or any combination thereof; or iii) any combination thereof; and wherein the male human has received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy, the method comprising administering to such male human a once-daily oral dosing of 300 mg niraparib.
The teachings of Smith et al. would have led one of ordinary skill to modify Claim 1 of the reference patent to arrive at the invention of claims 1, 3, 7, 8, 10, 11, 12 and 14 of the instant application. Motivation to do so, and a reasonable expectation of success, is provided by Smith et al. who teach successful clinical outcomes.
Therefore, 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.
US Patent No. 11,986,468
Claims 1, 3, 7, 8, 10, 11, 12 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,986,468 (reference patent) in view of Smith et al. (Annals of Oncology, Volume 30, Supplement 5, v844-v845, October 2019).
Claim 1 of the reference patent recites: A method of treating prostate cancer in a human in need of such treatment comprising administering to the human a therapeutically effective amount of niraparib or a salt thereof, wherein the prostate cancer is antiandrogen resistant and wherein the human (a) is not BRCA deficient or (b) is carrying at least one DNA repair anomaly in a gene selected from the group consisting of FANCA, PALB2, CHEK2, BRIP1, HDAC2, and ATM.
With regard to claims 1, 3, 7, 8, 10, 11, 12 and 14, Smith et al. teach: A method of improving the median overall survival (OS) in a male human with metastatic castration-resistant prostate cancer (mCRPC) with biallelic DNA-repair anomalies, wherein said biallelic DNA-repair anomalies are selected from: i) BRCA1, BRCA2, or a combination thereof, ii) ATM, FANCA, PALB2, CHEK2, BRIP1, HDAC2, or any combination thereof; or iii) any combination thereof; and wherein the male human has received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy, the method comprising administering to such male human a once-daily oral dosing of 300 mg niraparib.
The teachings of Smith et al. would have led one of ordinary skill to modify Claim 1 of the reference patent to arrive at the invention of claims 1, 3, 7, 8, 10, 11, 12 and 14 of the instant application. Motivation to do so, and a reasonable expectation of success, is provided by Smith et al. who teach successful clinical outcomes.
Therefore, 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.
US Patent No. 11,992,486
Claims 1, 2, 4-6, 9 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,992,486 (reference patent) in view of Smith et al. (Annals of Oncology, Volume 30, Supplement 5, v844-v845, October 2019).
Claim 1 of the reference patent recites: A method of treating prostate cancer in a human in need of such treatment comprising administering to the human a pharmaceutically acceptable amount of niraparib or a salt thereof, wherein the prostate cancer is antiandrogen resistant and wherein the human is carrying at least one DNA repair anomaly in a gene selected from the group consisting of BRCA-1 and BRCA-2.
With regard to claims 1, 2, 4-6, 9 and 13, Smith et al. teach: A method of improving the median overall survival (OS) in a male human with metastatic castration-resistant prostate cancer (mCRPC) with biallelic DNA-repair anomalies, wherein said biallelic DNA-repair anomalies are selected from: i) BRCA1, BRCA2, or a combination thereof, ii) ATM, FANCA, PALB2, CHEK2, BRIP1, HDAC2, or any combination thereof; or iii) any combination thereof; and wherein the male human has received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy, the method comprising administering to such male human a once-daily oral dosing of 300 mg niraparib.
The teachings of Smith et al. would have led one of ordinary skill to modify Claim 1 of the reference patent to arrive at the invention of claims 1, 2, 4-6, 9 and 13 of the instant application. Motivation to do so, and a reasonable expectation of success, is provided by Smith et al. who teach successful clinical outcomes.
Therefore, 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.
US Patent No. 12,383,543
Claims 1, 2, 4-6, 9 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,383,543 (reference patent) in view of Smith et al. (Annals of Oncology, Volume 30, Supplement 5, v844-v845, October 2019).
Claim 1 of the reference patent recites: A method of treating prostate cancer in a human in need of such treatment comprising administering to the human a therapeutically effective amount of niraparib or a salt thereof, wherein the prostate cancer is antiandrogen resistant and wherein the human is carrying at least one DNA repair anomaly in a gene selected from the group consisting of BRCA-1 and BRCA-2.
With regard to claims 1, 2, 4-6, 9 and 13, Smith et al. teach: A method of improving the median overall survival (OS) in a male human with metastatic castration-resistant prostate cancer (mCRPC) with biallelic DNA-repair anomalies, wherein said biallelic DNA-repair anomalies are selected from: i) BRCA1, BRCA2, or a combination thereof, ii) ATM, FANCA, PALB2, CHEK2, BRIP1, HDAC2, or any combination thereof; or iii) any combination thereof; and wherein the male human has received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy, the method comprising administering to such male human a once-daily oral dosing of 300 mg niraparib.
The teachings of Smith et al. would have led one of ordinary skill to modify Claim 1 of the reference patent to arrive at the invention of claims 1, 2, 4-6, 9 and 13 of the instant application. Motivation to do so, and a reasonable expectation of success, is provided by Smith et al. who teach successful clinical outcomes.
Therefore, 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.
Conclusion
No claim is currently allowable.
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