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 .
Response to Arguments
Claim Objections
In view of Applicant’s claim amendments, the objections are hereby withdrawn.
Claim Rejections - 35 USC § 112
In view of Applicant’s claim amendments, this rejection is hereby withdrawn.
Claim Rejections - 35 USC § 103
Applicant has withdrawn the claims, and made arguments against the claims as amended. In view of Applicant’s claim amendments, a modified rejection has been made below, which now renders Applicant’s arguments moot.
Double Patenting
In view of Applicant’s claim amendments, the rejections are hereby withdrawn.
Claims 40-50, 53, 54 and 58-63 are pending, and have been examined herewith to the extent of Applicant’s elected species.
Note to File on A Related Adjudicated Patent File Wrapper
While res judicata has not been invoked, because the instant claims are of a somewhat different scope, the Examiner notes that claims of a similar scope were already examined and rejected by a different examiner in patent application 15/950,707, were subsequently appealed to PTAB, which in turn affirmed the other examiner in 2023, and were then further affirmed on appeal by the Federal Circuit in 2024. Some related claims of the ‘707 application are noted for the record.
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The Examiner also notes in comparison some claims in the instant application.
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Claim Rejections - 35 USC § 112
(new)
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.
Claim 63 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 63 recites the limitations "diluent lactose monohydrate" in a) and b0. There is insufficient antecedent basis for this limitation in the claim. Claim 63 depends from claim 40, which does not recite a diluent.
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.
Claims 40-50, 53, 54 and 58-63 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018191141 A1 to Yu et al. (“Yu”, of record), and further in view of Zejula (niraparib) capsules, for oral use, FDA Reference ID: 4600207, initial US. Approval: 2017, revised 04/ 2020 (“FDA label for niraparib”, of record).
Yu discloses a method for treating a prostate cancer comprising administering to a patient a therapeutically effective amount of niraparib, a therapeutically effective amount of abiraterone acetate, and a therapeutically effective amount of prednisone (claim 1). The prostate cancer is hormone-sensitive or castration-resistant prostate cancer (claim 2). The prostate cancer may be metastatic ([0033]). Niraparib and abiraterone acetate are administered to the patient in a single composition, or in separate compositions (claims 3-4, [0035]). The route of administration may be oral (tablets, troches, lozenges, aqueous or oily suspensions, dispersible powders or granules, emulsions, hard or soft capsules, or syrups or elixirs) ([0043]). The dosing, either free dose or fixed dose are taught in paragraphs, to include specific dose of the drugs of Applicant’s claims 60 and 63. ([0035]-[0040]).
Yu further discloses that the composition may further contain additional excipients, such as disintegrating agents ([0043]), and names as an additional excipient polyvinyl polypyrrolidone ([0043], [0046]). It is noted that polyvinyl polypyrrolidone is an alternative name for crospovidone. Yu further discloses that additional ingredients include diluents, such as lactose. ([0043]).
The patient might have been previously treated with anti-androgens (i.e. medical castration per Applicant’s specification at para [0241]), to include for the pre-treatment times of Applicant’s claims 45-48. ([0034]). “Additionally or alternatively, the patient may have undergone at least one line of androgen receptor-targeted therapy prior to administering a first dose of the niraparib, abiraterone acetate, and prednisone. The period of time between the end of the other treatment and the administration of niraparib, abiraterone acetate, and prednisone in accordance with the present invention may be years, months, weeks, days, a single day, or less than 24 hours.” There is no indication in Yu that the patient should have undergone prior therapy with a next/ second generation androgen signaling inhibitor therapy, per Applicant’s claims 49 and 50.
Yu further provides motivation to specifically test for deleterious germline or somatic HRR gene mutations in prostate cancer as a part of the treatment, such as claimed by Applicant. It discloses that niraparib is a PARP inhibitor, and that the PARP inhibitor olaparib was recently investigated in a Phase 2 study to assess efficacy and safety in patients with mCRPC post-chemotherapy and AR-targeted agents, and that genetic sequencing identified homozygous deletions, deleterious mutations, or both in DNA-repair genes, including, but not limited to BRCA-1/2, ATM, Fanconi anemia genes, and CHEK2 in tumor samples. ([0004]-[0006]).
Even though the reference does not specifically indicate the niraparib as tosylate monohydrate and the lactose as lactose monohydrate, this was the pharmaceutical form used in therapy as to both, as exemplified by the FDA label for niraparib. (p. 16).
Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to combine the teachings of Yu and the FDA label for niraparib in order to practice Applicant’s claimed method with a reasonable expectation of success. The skilled artisan would have been motivated to do so guided by the desire to optimize the niraparib drug form with one, which has already gone through clinical testing. Even though Yu does not specifically disclose the amounts of the additional ingredients crospovidone and lactose monohydrate, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to optimize the amounts of these ingredients with a reasonable expectation of success in order to achieve good formulation disintegration and dilution.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627
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