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 .
Application Status
The preliminary amendment filed on 6/26/2025 is acknowledged. Claims 1-9 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement filed on 1/09/2025 is acknowledged and has been considered except where lined through.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Interpretation
Claim 1 recites a compound referred to as AZD5303 without specifically claiming the compound. At the time of the invention, the compound referred to as AZD5303 was synonymous with a compound having the chemical structure:
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(see STN Registry No: 2589531-76-8 (Entered STN: 2021-02-15)).
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 (i.e., changing from AIA to pre-AIA ) 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 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 7-8 is/are rejected under 35 U.S.C. 103 as being obvious over Agarwal et al. (Future Oncol. 2022; 18(4):425-436, IDS) in view of NCT04644068. “Study of AZD5305 as monotherapy and in combination with anti-cancer agents in patients with advanced solid malignancies (PETRA) ClinicalTrials.gov, (posted 2021-03-12).
Agarwal et al. teach the study design of a phase III clinical trial referred to as TALAPRO-2 involving administration of talazoparib in combination with enzalutamide in metastatic castration-resistant prostate cancer (Title). Specifically, Agarwal et al. teach that talazoparib is a potent PARP inhibitor that has been approved in both the USA and EU as a monotherapy for the treatment of patients with germline BRCA1/2-mutated, ERBB2-negative, locally advanced or metastatic breast cancer, wherein multiple preclinical studies and clinical evidence suggest the potential for PARP inhibitors to target tumors regardless of DDR alteration status when combined with AR signaling inhibitors (page 426, 1st and 2nd full paragraph). Moreover, Agarwal et al. teach that enzalutamide and AR inhibitor approved for the treatment of castration resistant prostate cancer and metastatic castration resistant prostate cancer, wherein enzalutamide completely inhibits androgen binding to androgen receptors (page 426, last paragraph). Additionally, Agarwal et al. teach that a phase II proof-of-concept study demonstrated that Olaparib (another PARP inhibitor) in combination with abiraterone significantly prolonged radiographic progression-free survival (rPFS) compared to abiraterone monotherapy in patients with mCRPC with and without DDR alterations (page 426, 2nd full paragraph, last few lines). With regards to the study, Agarwal et al. teach that TALAPRO-2 is a two part clinical trial to evaluate the efficacy, safety, pharmacokinetics and patient reported outcomes of talazoparib in combination with enzalutamide as a first line treatment of patients with mCRPC, wherein part 1 of the study confirmed the starting dose of 0.5mg/day of Talazoparib to be given in combination with 160mg/day of enzalutamide due to potential drug-drug interactions between the two molecules (page 427, Study Design). Lastly, Agarwal et al. teach that in addition to the currently study, there are a number of ongoing phase III trials evaluating different PARP inhibitors given together with novel androgen signaling inhibitors in both mCRPC patients, as well as, metastatic hormone-sensitive prostate cancer (see beginning on page 431, last paragraph to page 432).
Agarwal et al. do not specifically teach that the PARP inhibitor is a compound referred to as AZD5305.
NCT04644068 teaches a modular phase I/IIa, open-label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of ascending doses of AZD5305 as monotherapy and in combination with anti-cancer agents in patients with advanced solid malignancies (Official Title). With regards to AZD5305, NCT04644068 teaches that AZD5305 is a PARP inhibitor (see Study Description). With regards to the malignancies, NCT04644068 teaches that malignancies include, but are not limited to, ovarian, breast, pancreatic and prostate cancer (See conditions).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by Agarwal et al. so as to substitute one PARP inhibitor such as talazoparib for another such as AZD5305 in view of the teachings of NCT04644068. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Agarwal et al. teach that there are a number of ongoing phase III trials evaluating different PARP inhibitors given together with novel androgen signaling inhibitors in both mCRPC patients, as well as, metastatic hormone-sensitive prostate cancer.
As such, an ordinary skilled artisan would have been motivated to make such a substitution to predictably arrive at a method of treating cancer comprising administering a PARP inhibitor in combination with an AR therapy. See also MPEP 2144.06.
Claims 4-6 is/are rejected under 35 U.S.C. 103 as being obvious over Agarwal et al. (Future Oncol. 2022; 18(4):425-436, IDS) in view of NCT04644068. “Study of AZD5305 as monotherapy and in combination with anti-cancer agents in patients with advanced solid malignancies (PETRA) ClinicalTrials.gov, (posted 2021-03-12), as applied above to claims 1-3 and 7-8, in further view of AstraZeneca AB (WO2021/013735A1).
The combination of Agarwal et al. and NCT04644068 have been described above and incorporated herein.
The combination does not specifically teach that AZD5305 was given in the amounts claimed
AstraZeneca teach azaquinolones having the generic structure:
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useful for treating diseases or conditions in which PARP1 inhibition is beneficial such as cancer (Page 2, lines 14-31). Moreover, AstraZeneca teach that suitable doses of the compounds in the therapeutic treatment of humans is from 0.0001-100 mg/kg body weight, wherein the compound is administered at varying doses depending upon the disorder and patient to be treated (page 7, lines 30-34 and page 8, lines 20-21). With regards to the compounds, AstraZeneca teaches that the compounds include, but are not limited to, a compound having the structure
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(see page 16, Example 4).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to optimize the amount of AZD5305 in the treatment method taught by the combination in view of the teachings of AstraZeneca. One of ordinary skill in the art would have been motivated to make such an optimization, with a reasonable expectation of success, because:
-Both Agrawal et al. and NCT04644068 teach that clinical trials involve the optimization of the dose of the active agent, and
- AstraZeneca teaches compounds encompassing AZD5305, wherein the actual dose of the compound will depend on the condition treated and patient and can vary between 0.0001-100 mg/kg body weight.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Claims 4-6 is/are rejected under 35 U.S.C. 103 as being obvious over Agarwal et al. (Future Oncol. 2022; 18(4):425-436, IDS) in view of NCT04644068. “Study of AZD5305 as monotherapy and in combination with anti-cancer agents in patients with advanced solid malignancies (PETRA) ClinicalTrials.gov, (posted 2021-03-12) and AstraZeneca AB (WO2021/013735A1), as applied above to claims 1-8, in further view of Bushra et al. (Oman Medical Journal 2011; 26(2): 77-83).
The combination of Agarwal et al., NCT04644068 and AstraZeneca have been discussed above and incorporated herein.
The combination does not teach that the patient had not eaten prior to administration of the combination of agents.
Bushra et al. teach that the effect of a drug on a person may be different than expected because the drug interacts with another drug the person is taking (drug-drug interaction), food, beverages, dietary supplements the person is consuming or another disease the person has, wherein food-drug interactions, physicians and pharmacists recognize that some foods and drugs, when taking simultaneously, can alter the ability to utilize a particular food or drug or cause serious side effects (abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by the combination to avoid food prior to administration of the combination of drugs in view of the teachings of Bushra et al. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- physicians and pharmacists recognize that some foods and drugs, when taking simultaneously, can alter the ability to utilize a particular food or drug or cause serious side effects.
Claims 1-8 is/are rejected under 35 U.S.C. 103 as being obvious over Agarwal et al. (Future Oncol. 2022; 18(4):425-436, IDS) in view of Staniszewska et al. (Cancer Resear 2021; 81 (13 Suppl): Abstract 1270, IDS).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Agarwal et al. teach the study design of a phase III clinical trial referred to as TALAPRO-2 involving administration of talazoparib in combination with enzalutamide in metastatic castration-resistant prostate cancer (Title). Specifically, Agarwal et al. teach that talazoparib is a potent PARP inhibitor that has been approved in both the USA and EU as a monotherapy for the treatment of patients with germline BRCA1/2-mutated, ERBB2-negative, locally advanced or metastatic breast cancer, wherein multiple preclinical studies and clinical evidence suggest the potential for PARP inhibitors to target tumors regardless of DDR alteration status when combined with AR signaling inhibitors (page 426, 1st and 2nd full paragraph). Moreover, Agarwal et al. teach that enzalutamide and AR inhibitor approved for the treatment of castration resistant prostate cancer and metastatic castration resistant prostate cancer, wherein enzalutamide completely inhibits androgen binding to androgen receptors (page 426, last paragraph). Additionally, Agarwal et al. teach that a phase II proof-of-concept study demonstrated that Olaparib (another PARP inhibitor) in combination with abiraterone significantly prolonged radiographic progression-free survival (rPFS) compared to abiraterone monotherapy in patients with mCRPC with and without DDR alterations (page 426, 2nd full paragraph, last few lines). With regards to the study, Agarwal et al. teach that TALAPRO-2 is a two part clinical trial to evaluate the efficacy, safety, pharmacokinetics and patient reported outcomes of talazoparib in combination with enzalutamide as a first line treatment of patients with mCRPC, wherein part 1 of the study confirmed the starting dose of 0.5mg/day of Talazoparib to be given in combination with 160mg/day of enzalutamide due to potential drug-drug interactions between the two molecules (page 427, Study Design). Lastly, Agarwal et al. teach that in addition to the currently study, there are a number of ongoing phase III trials evaluating different PARP inhibitors given together with novel androgen signaling inhibitors in both mCRPC patients, as well as, metastatic hormone-sensitive prostate cancer (see beginning on page 431, last paragraph to page 432).
Agarwal et al. do not specifically teach that the PARP inhibitor is a compound referred to as AZD5305 or that AZD5305 is administered at the claimed amounts.
Staniszewska et al. teach that the novel PARP1-selective inhibitor, AZD5305, is efficacious as monotherapy and in combination with standard of care chemotherapy in in vivo preclinical models (Title). Specifically, Staniszewska et al. teach that AZD5305 dosed at 0.1mg/kg QD or higher for 35 days delivered about 90% regression in BRCA1m triple-negative breast cancer (TNBC), compared with 83% regression caused by the treatment with 100 mg/kg QD Olaparib, wherein the anti-tumor effects of AZD5305 continued after cessation of treatment and complete responses were achieved which were sustained for the whole duration of the study, over 100 days after treatment withdrawal (2nd paragraph of abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by Agarwal et al. so as to substitute one PARP inhibitor such as talazoparib for another such as AZD5305 in view of the teachings of Staniszewska et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Agarwal et al. teach that there are a number of ongoing phase III trials evaluating different PARP inhibitors given together with novel androgen signaling inhibitors in both mCRPC patients, as well as, metastatic hormone-sensitive prostate cancer; and
-.Staniszewska et al. teach that AZD5305 dosed at 0.1mg/kg QD or higher for 35 days delivered about 90% regression in BRCA1m triple-negative breast cancer (TNBC), compared with 83% regression caused by the treatment with 100 mg/kg QD Olaparib, wherein the anti-tumor effects of AZD5305 continued after cessation of treatment and complete responses were achieved which were sustained for the whole duration of the study, over 100 days after treatment withdrawal
As such, an ordinary skilled artisan would have been motivated to make such a substitution to predictably arrive at a method of treating cancer comprising administering a PARP inhibitor in combination with an AR therapy. See also MPEP 2144.06.
Moreover, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to optimize the amount of AZD5303 in the treatment method taught by the combination. One of ordinary skill in the art would have been motivated to make such an optimization, with a reasonable expectation of success, because:
-Staniszewska et al. teach that AZD5305 dosed at 0.1mg/kg QD or higher for 35 days delivered about 90% regression in BRCA1m triple-negative breast cancer (TNBC), compared with 83% regression caused by the treatment with 100 mg/kg QD Olaparib.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Claim 9 is/are rejected under 35 U.S.C. 103 as being obvious over Agarwal et al. (Future Oncol. 2022; 18(4):425-436, IDS) in view of Staniszewska et al. (Cancer Resear 2021; 81 (13 Suppl): Abstract 1270, IDS), as applied above to claims 1-8, in further view of in further view of Bushra et al. (Oman Medical Journal 2011; 26(2): 77-83).
The combination of Agarwal et al. and Staniszewska et al. have been discussed above and incorporated herein.
The combination does not teach that the patient had not eaten prior to administration of the combination of agents.
Bushra et al. teach that the effect of a drug on a person may be different than expected because the drug interacts with another drug the person is taking (drug-drug interaction), food, beverages, dietary supplements the person is consuming or another disease the person has, wherein food-drug interactions, physicians and pharmacists recognize that some foods and drugs, when taking simultaneously, can alter the ability to utilize a particular food or drug or cause serious side effects (abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by the combination to avoid food prior to administration of the combination of drugs in view of the teachings of Bushra et al. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- physicians and pharmacists recognize that some foods and drugs, when taking simultaneously, can alter the ability to utilize a particular food or drug or cause serious side effects.
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.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1-6 of copending Application No. 18853520 in view of Agarwal et al. (Future Oncol. 2022; 18(4):425-436, IDS).
The copending application claims:
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The copending application differs from the instant application in that it claims abiraterone acetate and not enzalutamide.
Agarwal et al. teach the study design of a phase III clinical trial referred to as TALAPRO-2 involving administration of talazoparib in combination with enzalutamide in metastatic castration-resistant prostate cancer (Title). Specifically, Agarwal et al. teach that talazoparib is a potent PARP inhibitor that has been approved in both the USA and EU as a monotherapy for the treatment of patients with germline BRCA1/2-mutated, ERBB2-negative, locally advanced or metastatic breast cancer, wherein multiple preclinical studies and clinical evidence suggest the potential for PARP inhibitors to target tumors regardless of DDR alteration status when combined with AR signaling inhibitors (page 426, 1st and 2nd full paragraph). Moreover, Agarwal et al. teach that enzalutamide and AR inhibitor approved for the treatment of castration resistant prostate cancer and metastatic castration resistant prostate cancer, wherein enzalutamide completely inhibits androgen binding to androgen receptors (page 426, last paragraph). Additionally, Agarwal et al. teach that a phase II proof-of-concept study demonstrated that Olaparib (another PARP inhibitor) in combination with abiraterone significantly prolonged radiographic progression-free survival (rPFS) compared to abiraterone monotherapy in patients with mCRPC with and without DDR alterations (page 426, 2nd full paragraph, last few lines). With regards to the study, Agarwal et al. teach that TALAPRO-2 is a two part clinical trial to evaluate the efficacy, safety, pharmacokinetics and patient reported outcomes of talazoparib in combination with enzalutamide as a first line treatment of patients with mCRPC, wherein part 1 of the study confirmed the starting dose of 0.5mg/day of Talazoparib to be given in combination with 160mg/day of enzalutamide due to potential drug-drug interactions between the two molecules (page 427, Study Design). Lastly, Agarwal et al. teach that in addition to the currently study, there are a number of ongoing phase III trials evaluating different PARP inhibitors given together with novel androgen signaling inhibitors in both mCRPC patients, as well as, metastatic hormone-sensitive prostate cancer (see beginning on page 431, last paragraph to page 432).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method claimed by the copending application so as to substitute one AR inhibitor such as abiraterone acetate for another such as enzalutamide in view of the teachings of Agarwal et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Agarwal et al. teach that there are a number of ongoing phase III trials evaluating different PARP inhibitors given together with novel androgen signaling inhibitors in both mCRPC patients, as well as, metastatic hormone-sensitive prostate cancer.
As such, an ordinary skilled artisan would have been motivated to make such a substitution to predictably arrive at a method of treating cancer comprising administering a PARP inhibitor in combination with an AR therapy. See also MPEP 2144.06.
This is a provisional nonstatutory double patenting rejection.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1-6 and 9 of copending Application No. 18853491 in view of Agarwal et al. (Future Oncol. 2022; 18(4):425-436, IDS).
The copending application claims:
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The copending application differs from the instant application in that it claims darolutamide and not enzalutamide.
Agarwal et al. teach the study design of a phase III clinical trial referred to as TALAPRO-2 involving administration of talazoparib in combination with enzalutamide in metastatic castration-resistant prostate cancer (Title). Specifically, Agarwal et al. teach that talazoparib is a potent PARP inhibitor that has been approved in both the USA and EU as a monotherapy for the treatment of patients with germline BRCA1/2-mutated, ERBB2-negative, locally advanced or metastatic breast cancer, wherein multiple preclinical studies and clinical evidence suggest the potential for PARP inhibitors to target tumors regardless of DDR alteration status when combined with AR signaling inhibitors (page 426, 1st and 2nd full paragraph). Moreover, Agarwal et al. teach that enzalutamide and AR inhibitor approved for the treatment of castration resistant prostate cancer and metastatic castration resistant prostate cancer, wherein enzalutamide completely inhibits androgen binding to androgen receptors (page 426, last paragraph). Additionally, Agarwal et al. teach that a phase II proof-of-concept study demonstrated that Olaparib (another PARP inhibitor) in combination with abiraterone significantly prolonged radiographic progression-free survival (rPFS) compared to abiraterone monotherapy in patients with mCRPC with and without DDR alterations (page 426, 2nd full paragraph, last few lines). With regards to the study, Agarwal et al. teach that TALAPRO-2 is a two part clinical trial to evaluate the efficacy, safety, pharmacokinetics and patient reported outcomes of talazoparib in combination with enzalutamide as a first line treatment of patients with mCRPC, wherein part 1 of the study confirmed the starting dose of 0.5mg/day of Talazoparib to be given in combination with 160mg/day of enzalutamide due to potential drug-drug interactions between the two molecules (page 427, Study Design). Lastly, Agarwal et al. teach that in addition to the currently study, there are a number of ongoing phase III trials evaluating different PARP inhibitors given together with novel androgen signaling inhibitors in both mCRPC patients, as well as, metastatic hormone-sensitive prostate cancer (see beginning on page 431, last paragraph to page 432).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method claimed by the copending application so as to substitute one AR inhibitor such as darolutamide for another such as enzalutamide in view of the teachings of Agarwal et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Agarwal et al. teach that there are a number of ongoing phase III trials evaluating different PARP inhibitors given together with novel androgen signaling inhibitors in both mCRPC patients, as well as, metastatic hormone-sensitive prostate cancer.
As such, an ordinary skilled artisan would have been motivated to make such a substitution to predictably arrive at a method of treating cancer comprising administering a PARP inhibitor in combination with an AR therapy. See also MPEP 2144.06.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Therefore, No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/ Primary Examiner, Art Unit 1626
Prosecution Insights