CTNF 18/833,519 CTNF 76060 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-30-03-h AIA Claim Interpretation Claim 14 recites “ a drug product comprising a two-drug combination of 100 mg niraparib and 500 mg abiraterone acetate ”. In present specification (pg.8, lines 18-19), applicant define the term “drug product” as a pharmaceutical formulation that contains niraparib and abiraterone acetate . Then, on pg.9, lines 1-18 of present specification, applicant state that the term “formulation” (or “composition”) refers to combining two active pharmaceutical ingredients , either as fixed-dosed combinations or as free-dose combinations . Applicant further state that “ fixed-dose combination ” are formulations or compositions that include abiraterone acetate and niraparib in a single oral dosage form, whereas a “ free-dose combination ” are formulations or compositions that include two or more active ingredients combined in separate dosage forms, for example, 1) a dosage form comprising abiraterone acetate and 2) a separate dosage form comprising niraparib. Based on the reading of present specification , the Examiner interprets the phrase of claim 1 “ a drug product comprising a two-drug combination of 100 mg niraparib and 500 mg abiraterone acetate ” to mean a drug formulation (or composition) containing niraparib and abiraterone, either in a single oral dosage form or in separate dosage forms . Claim Objections 07-29-01 AIA Claim 24 is objected to because of the following informalities: on line 4, applicant need to insert --- and --- in front of “Sodium lauryl sulfate” . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 14-29 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. It is not clear from the claim language of claim 14 what active steps are actually required in instant method of claim 14. In order to make the scope of claim 14 clear (and thus to overcome instant 112(b) rejection), the Examiner would like to suggest applicant to change claim 14 to recite the following: --- A method of improving . . ., in a patient with . . . (mCRPC), who is positive for germline and/or somatic . . . (HRR) gene alterations(s), wherein said HRR gene alteration(s) are selected from one or more alterations in any one of the groups selected from: . . . d) . . . , or PALB2 ; said method comprising administering to said patient (i) a drug product comprising a two-drug combination of 100 mg niraparib and 500 mg abiraterone acetate and (ii) prednisone or prednisolone in order to reach the daily dosage for improving the median rPFS, wherein the daily dosage is: a single dose of 200 mg of niraparib and 1000 mg of abiraterone acetate and a dose of 10 mg of prednisone or prednisolone. --- . 07-34-01 Claim 15 is 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. Claim 15 recites that “ mCRPC is first-line (L1) mCRPC” . Such phrase is confusing and indefinite, because “mCRPC” refers to a cancer and “first-line (L1) mCRPC” refers to a first-line treatment used for the mCRPC (so the phrase “mCRPC is first-line (L1) mCRPC” literally translates to “mCRPC is first line treatment used for the mCRPC”). It is also unclear from the claim language whether “a patient” recited on line 2 of claim 15 is the same patient mentioned in claim 14. In order to overcome instant 112(b) rejection on claim 15, the Examiner would like to suggest applicant to change claim 15 to recite the following: --- The method of claim 14, wherein said patient has not been treated with any therapy in the metastatic castrate-resistant setting, except for i) androgen deprivation therapy (ADT), and/or ii) a prior exposure to abiraterone acetate plus prednisone or prednisolone for up to 2 or 4 months, and wherein said method is a first-line (L1) treatment said patient receives for the mCRPC. --- . 07-34-01 Claim 24 is 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. 07-34-05 AIA Claim 24 recites the limitation " the film-coated tablet " in lines 1-2 . There is insufficient antecedent basis for this limitation in the claim. 07-34-01 Claim 25 is 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. 07-34-05 AIA Claim 25 recites the limitation " the tablet " in lines 1-2 . There is insufficient antecedent basis for this limitation in the claim. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. 07-15 AIA Claim (s) 14-29 are rejected under 35 U.S.C. 102( a)(1) or 102(a)(2 ) as being anticipated by Quinten et al (WO 2021/224467 A1) ( with Monga et al (US 2023/0110113 A1, which is being cited here merely to support the Examiner’s assertion that Opadry TR AMB II 88A 170010 (used in Quinten) contains glycerol monocaprylocaprate, polyvinyl alcohol, sodium lauryl sulfate, talc, titanium dioxide, iron oxide yellow, and iron oxide red ) . Quinten teaches ( pg.5, lines 8-24 ) a method for treating mCRPC in a male human patient, who is positive for homologous recombination deficiency (HRD) ( also referred to as homologous recombination repair (HRR) defects (see pg.34, lines 21-23)), wherein the HRD status is detected by monoallelic or biallelic alterations in one or more DNA repair genes including BRCA1 and BRCA2 . The method comprises administering to the patient an effective amount of a pharmaceutical formulation comprising abiraterone acetate and niraparib tosylate monohydrate, plus prednisone , and such treatment is first-line (L1) treatment of mCRPC : the patient has not been treated with abiraterone acetate plus prednisone for more than 5 months ( thus, Quinten teaches or renders obvious instant limitation of claim 15 ). The patient has received GnRHa therapy or has undergone bilateral orchiectomy , prior to the treatment with the pharmaceutical formulation plus prednisone, and the GnRHa therapy continues during the treatment with the pharmaceutical formulation plus prednisone, if not surgically castrated ( thus, Quinten teaches instant limitations of claims 19 and 20 ). With respect to instant dosage regimen , Quinten teaches (pg.43, lines 19-21) that the fixed-dose combination (FDC) of its invention may be a regular strength dose, which is 200 mg eq. of niraparib / 1000 mg abiraterone acetate , given as 2 x FDC tablets ( each tablet having 100 mg eq. niraparib/500 mg abiraterone acetate ), administered orally as one daily dose ( instant single dose ) under modified fasted conditions. Quinten further teaches (pg.39, line 14) that for the patient having mCRPC, the daily dose of prednisone is 10 mg . Thus, Quinten teaches instant daily dosage for improving the median rPFS , which is a single dose of 200 mg of niraparib and 1000 mg of abiraterone acetate and a dose of 10 mg of prednisone . Thus, it follows that Quinten’s method (as discussed above) would inherently improve the median rPFS in a patient with mCRPC who is positive for germline and/or somatic homologous recombination repair (HRR) gene alteration(s) as instantly recited in the pre-amble of claim 14. Thus, Quinten teaches instant claims 14-20 and 23 ( as to instant claim 16, a patient with mCRPC already implies that he was initially a patient with prostate cancer who has progressed to mCRPC ; as to instant claims 17 and 18, since Quinten teaches instant method of claim 14, with the HRR gene alterations being selected from BRCA2 or BRCA1, instant limitations of claims 17 and 18 as to the improved median rPFS would inherently be satisfied ). With respect to instant claim 21 , Quinten teaches (pg.6, lines 21-23) that the male patient with mCRPC has been exposed to anti-androgens selected from nilutamide, flutamide, bicalutamide, enzalutamide, apalutamide, darolutamide and abiraterone acetate . Thus, Quinten teaches instant claim 21 . With respect to instant claims 22 and 29 , Quinten teaches (pg.6, lines 2-4) that its male patient has received docetaxel or cabazitaxel ( instant taxane chemotherapy ) prior to the treatment with the pharmaceutical formulation, plus prednisone. Thus, Quinten teaches instant claims 22 and 29 . With respect to instant claims 25, 27 and 28 , Quinten teaches instant tablet composition of claim 25 and instant film-coated tablet of claim 27 in its Tables 3 and 4 (see pg.46). Thus, Quinten teaches instant claims 25, 27 and 28 . With respect to instant claim 26 , Quinten teaches (pg.8, lines 3-4 and pg.13, lines 29-30) that the oral dosage form for its pharmaceutical formulation can be a capsule further comprising a diluent. Thus, Quinten teaches instant claim 26 . With respect to instant claim 24 , Quinten’s Table 3 (on pg.46) teaches instant tablet core composition of claim 24. As to instant film-coating composition, Quinten’s Table 4 teaches that the film-coating for its tablet (of Table 3) is formed of Opadry TR AMB II 88A 170010, which is the same film-coating material used in present working example (see Tables 4 and 10 of present specification) and contains glycerol monocaprylocaprate, polyvinyl alcohol, sodium lauryl sulfate, talc, titanium dioxide, iron oxide yellow, and iron oxide red ( as evidenced by Monga et al ([0191]). Thus, Quentin teaches instant claim 24 . It is to be noted that US 2023/0218640 A1 , 2023/0226081 A1 , US 2023/0226080 A1 , and US 2026/0097048 A1 teach instant invention for the similar reasons as explained in paragraph 10 above. However, prior art rejections over these references were not made in this Office Action in order to avoid making merely cumulative rejections (MPEP 706.02). Applicant need to file statement of common ownership for these references so as to avoid prior art rejections over these references in the future . Claim Rejections - 35 USC § 103 07-20-02-aia AIA 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim (s) 14-21, 23 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trials “A Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer (MAGNITUDE)”, ClinicalTrials.gov ID NCT03748641 ( Version 26 ) ( October 8, 2020 ) ( obtained from the website: https://clinicaltrials.gov/study/NCT03748641?tab=history&a=26#version-content-panel ) in view of von Werdt et al (“PARP Inhibition in Prostate Cancer With Homologous Recombination Repair Alterations”, JCO Precis Oncol. vol.5 (Oct 22, 2021), pg.1639-1649), McGurk et al (WO 2019/152989 A1) and Murphy et al (US 2015/0246060 A1) . Clinical Trials teaches (see under “Study Description”) that the purpose of its study is to evaluate the effectiveness of niraparib (a highly selective PARP inhibitor) in combination with abiraterone acetate plus prednisone compared to abiraterone acetate plus prednisone (AAP) plus placebo in subjects with metastatic castration-resistant prostate cancer (instant mCRPC). Clinical Trials teaches (see under “Arms and Interventions”) that in Cohort 1, participants with mCRPC and HRR gene alteration were given a combination of 200 mg niraparib and 1000 mg abiraterone acetate , plus 10 mg prednisone once daily . Although Clinical Trials does not explicitly teach the specific HRR gene alterations listed in claim 14 , it is known in the art, as evidenced by von Werdt (see abstract), that in advanced prostate cancer, patients with BRCA1/2 or ATM mutations, poly(ADP-ribose) polymerase inhibition (PARPi) causes an increased overall survival advantage compared with patients without these mutations. Since niraparib is a PARP inhibitor (as indicated above), it would be obvious to one skilled in the art to administer the combination of 200 mg niraparib and 1000 mg abiraterone acetate , plus 10 mg prednisone once daily to the participants who have mCRPC and are positive for HRR defects selected from BRCA1 or BRCA2 with a reasonable expectation of increasing their overall survival advantage compared with participants without such gene mutations. As to instant pre-amble of claim 14, as shown above, Clinical Trials teaches instant daily dosage for the method of improving the median rPFS, which is a single dose of 200 mg of niraparib and 1000 mg of abiraterone acetate and a dose of 10 mg of prednisone or prednisolone , which means that the administration of the combination of 200 mg niraparib and 1000 mg abiraterone acetate , plus 10 mg prednisone once daily in Clinical Trials would inherently improve the median rPFS in the participant with mCRPC, who is positive for germline and/or somatic HRR gene alterations (BRCA1 or BRCA2). As to instant limitation “a drug product comprising a two-drug combination of 100 mg niraparib and 500 mg abiraterone acetate”, although Clinical Trials does not teach instant limitation, as evidenced by McGurk et al ([0056], [0057] and [0059]), it is known in the art that niraparib is available in capsule or tablet form in a unit dose of 100 mg. It is also known in the art, as evidenced by Murphy et al ([0021]), that abiraterone acetate is available in capsule or tablet form in a unit dose of 500 mg. It would be obvious to one skilled in the art to use in Clinical Trials, niraparib in capsule or tablet form with a unit dose of 100 mg and use abiraterone acetate in capsule or tablet form with a unit dose of 500 mg for the administration of the combination of 200 mg niraparib and 1000 mg abiraterone acetate, plus 10 mg prednisone once daily with a reasonable expectation of success. Thus, Clinical Trials in view of von Werdt, McGurk and Murphy renders obvious instant claims 14 and 16 ( as to instant claim 16, participants with mCRPC already implies that they were initially patients with prostate cancer who have progressed to mCRPC ). With respect to instant claims 15 and 21 , Clinical Trials teaches (see under “Eligibility”) that exclusion criteria for the participants for its study includes more than 4 months of abiraterone acetate plus prednisone prior to the study (which implies that a participant who has taken less than 4 months of abiraterone acetate (plus prednisone) prior to the study can participate). Thus, Clinical Trials in view of von Werdt, McGurk and Murphy renders obvious instant claims 15 and 21. With respect to instant claims 17 and 18 , since Clinical Trials as modified by the teachings of von Werdt, McGurk and Murphy teaches instant method of claim 14, with the HRR gene alterations being selected from BRCA2 or BRCA1, instant limitations of claims 17 and 18 as to the improved median rPFS would naturally be satisfied. Thus, Clinical Trials in view of von Werdt, McGurk and Murphy renders obvious instant claims 17 and 18. With respect to instant claims 19 and 20 , Clinical Trials teaches (see under “Eligibility”) that its inclusion criteria include participants who have metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to 50 ng/dL on a GnRHa or bilateral orchiectomy and are able to continue GnRHa during the study if not surgically castrate. Thus, Clinical Trials in view of von Werdt, McGurk and Murphy renders obvious instant claims 19 and 20. With respect to instant claim 23 , McGurk teaches that the niraparib may be in a salt form of tosylate monohydrate. Thus, Clinical Trials in view of von Werdt, McGurk and Murphy renders obvious instant claim 23. With respect to instant claim 26 , although in Cohort 1, the participants were given separate formulations for niraparib and abiraterone acetate, Clinical Trials also contemplates (see Cohort 3) giving a single formulation containing the two drugs . It would be obvious to one skilled in the art to administer a single formulation (in a capsule form) containing niraparib and abiraterone acetate to the participants as a matter of convenience. Also, when niraparib and abiraterone acetate are administered in a capsule form, the capsule is bound to include necessary carriers or excipients. Thus, Clinical Trials in view of von Werdt, McGurk and Murphy renders obvious instant claim 26 . 07-22-aia AIA Claim (s) 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trials “A Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer (MAGNITUDE)”, ClinicalTrials.gov ID NCT03748641 ( Version 26 ) ( October 8, 2020 ) ( obtained from the website: https://clinicaltrials.gov/study/NCT03748641?tab=history&a=26#version-content-panel ) in view of von Werdt et al (“PARP Inhibition in Prostate Cancer With Homologous Recombination Repair Alterations”, JCO Precis Oncol. vol.5 (Oct 22, 2021), pg.1639-1649), McGurk et al (WO 2019/152989 A1) and Murphy et al (US 2015/0246060 A1) as applied to claim 14 above, and further in view of Gauthier et al (US 2004/0081690 A1) . The Examiner established above that it would be obvious to one skilled in the art to use in Clinical Trials, niraparib in tablet form with a unit dose of 100 mg and use abiraterone acetate in tablet form with a unit dose of 500 mg (for the administration of the combination of 200 mg niraparib and 1000 mg abiraterone acetate, plus 10 mg prednisone once daily). Furthermore, even though in Cohort 1, the participants were given separate formulations for niraparib and abiraterone acetate, Clinical Trials also contemplates (see Cohort 3) giving a single formulation containing the two drugs . It would be obvious to one skilled in the art to use a single formulation ( in a tablet form ) containing 100 mg of niraparib and 500 mg of abiraterone acetate in Clinical Trials as a matter of convenience. Clinical Trials in view of the other cited prior arts does not teach that the tablet is film-coated. However , as evidenced by Gauthier ([0006]), it is well known in the art to film-coat a tablet so as to provide a protective film coating around the tablet, improved mechanical strength and improved visual aspect for the tablet. It would be obvious to one skilled in the art to film-coat the tablet containing 100 mg niraparib and 500 mg abiraterone acetate in Clinical Trials with a reasonable expectation of providing a protective film coating around the tablet, improved mechanical strength and improved visual aspect for the tablet. Thus, Clinical Trials in view of von Werdt, McGurk and Murphy, and further in view of Gauthier renders obvious instant claim 27 . With respect to instant claim 28 , the Examiner established above that it would be obvious to one skilled in the art to use in Clinical Trials, niraparib in tablet form with a unit dose of 100 mg and use abiraterone acetate in tablet form with a unit dose of 500 mg for the administration of the combination of 200 mg niraparib and 1000 mg abiraterone acetate, plus 10 mg prednisone once daily with a reasonable expectation of success. This means that the single dose of 200 mg of niraparib and 1000 mg of abiraterone acetate would correspond to two film-coated tablets. Thus, Clinical Trials in view of von Werdt, McGurk and Murphy, and further in view of Gauthier renders obvious instant claim 28 . Double Patenting 08-33 AIA 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. Claims 14-18, 23, 27 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 65, 72-75, 90, 91, 93, 94 and 96 of copending Application No. 17/998,204 (reference application) in view of von Werdt et al (“PARP Inhibition in Prostate Cancer With Homologous Recombination Repair Alterations”, JCO Precis Oncol. vol.5 (Oct 22, 2021), pg.1639-1649). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reason: Claims 65, 72, 90, 91 and 96 of App.’204 teach a method for treating mCRPC for the patient who is positive for HRR defects ( claim 91 of App.’204 also teaches that the method of claim 90 is first-line mCRPC treatment ), the method comprising administering to the patient an oral dosage form comprising a granule composition, which comprises abiraterone acetate, niraparib tosylate monohydrate and a pharmaceutically acceptable carrier. Claim 73 of App.’204 teaches that such oral dosage form can comprise 100 mg eq. niraparib and 500 mg abiraterone acetate, and claims 93 and 94 teach that the method can comprise administering 2 dosage forms per day and that the administration can take place once a day . Based on such teaching, it would be obvious to one skilled in the art to administer two oral dosage forms, once a day . Since each oral dosage form contains 100 mg eq. niraparib and 500 mg abiraterone acetate, this gives a single dose of 200 mg eq. niraparib and 1000 mg abiraterone acetate daily . Claim 96 of App.’204 teaches that the method of claim 90 also comprises administering separately 10 mg/day of prednisone or prednisolone . The single dose of 200 mg eq. niraparib and 1000 mg abiraterone acetate daily and the daily dose of 10 mg of prednisone or prednisolone teach instant daily dosage of claim 14 for improving the median rPFS . Thus, the administration method (as discussed above) as taught by the claims of App.’204 would inherently improve the median rPFS in a patient with mCRPC, who is positive for germline and/or somatic HRR gene alterations. Although claims of App.’204 do not explicitly teach the specific HRR gene defects of instant claim 14 , it is known in the art, as evidenced by von Werdt (see abstract), that in advanced prostate cancer, patients with BRCA1/2 or ATM mutations, poly(ADP-ribose) polymerase inhibition (PARPi) causes an increased overall survival advantage compared with patients without these mutations. Since niraparib is a PARP inhibitor (see pg.27, lines 8-10 of present specification), it would be obvious to one skilled in the art to treat mCRPC for the patients who are positive for HRR defects selected from BRCA1 or BRCA2 by administering to the patients an oral dosage form comprising niraparib tosylate monohydrate, abiraterone acetate and a pharmaceutically acceptable carrier (as discussed in the claims of App.’204) with a reasonable expectation of increasing their overall survival advantage compared with patients without such gene mutations. Thus, the claims of App.’204 in view of von Werdt render obvious instant claims 14, 15, 16 and 23 . With respect to instant claims 17 and 18 , since the claims of App.’204 in view of von Werdt teach instant method of claim 14 wherein the HRR gene alterations are selected from BRCA2 or BRCA1, instant limitations of claims 17 and 18 as to the improved median rPFS would inherently be satisfied. Thus, claims of App.’204 in view of von Werdt render obvious instant claims 17 and 18 . With respect to instant claims 27 and 28 , claims 74 and 75 of App.’204 teach that the oral dosage form of claim 72 is a tablet and that the pharmaceutically acceptable carrier further comprises a coating material. Thus, the claims of App.’204 teach instant two drug combination of 100 mg niraparib and 500 mg abiraterone acetate formulated with a pharmaceutically acceptable carrier in a film-coated tablet . Also, since the claims of App.’204 teach (as discussed above) administering two oral dosage forms, once a day , the claims of App.’204 teach instant single dose of 200 mg of niraparib and 1000 mg of abiraterone acetate, which corresponds to two film-coated tablets as recited in instant claim 28. Thus, claims of App.’204 in view of von Werdt render obvious instant claims 27 and 28 . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 07-101 Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. 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). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. /SIN J LEE/ Primary Examiner, Art Unit 1613 June 13, 2026 Application/Control Number: 18/833,519 Page 2 Art Unit: 1613 Application/Control Number: 18/833,519 Page 3 Art Unit: 1613 Application/Control Number: 18/833,519 Page 4 Art Unit: 1613 Application/Control Number: 18/833,519 Page 5 Art Unit: 1613 Application/Control Number: 18/833,519 Page 6 Art Unit: 1613 Application/Control Number: 18/833,519 Page 7 Art Unit: 1613 Application/Control Number: 18/833,519 Page 8 Art Unit: 1613 Application/Control Number: 18/833,519 Page 9 Art Unit: 1613 Application/Control Number: 18/833,519 Page 10 Art Unit: 1613 Application/Control Number: 18/833,519 Page 11 Art Unit: 1613 Application/Control Number: 18/833,519 Page 12 Art Unit: 1613 Application/Control Number: 18/833,519 Page 13 Art Unit: 1613 Application/Control Number: 18/833,519 Page 14 Art Unit: 1613 Application/Control Number: 18/833,519 Page 15 Art Unit: 1613 Application/Control Number: 18/833,519 Page 16 Art Unit: 1613 Application/Control Number: 18/833,519 Page 17 Art Unit: 1613 Application/Control Number: 18/833,519 Page 18 Art Unit: 1613 Application/Control Number: 18/833,519 Page 19 Art Unit: 1613
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