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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/19/2026 has been entered.
Response to Arguments
Applicant’s arguments, see Pages 3-6, filed 03/19/2026, with respect to the rejection(s) of claims 1, 4-5, 7-11, 13-14, 18 and 20-22 under Cai et al. (WO 2012130166 A1) in view of Wang et al. (WO 2019015561 A1) have been fully considered but they are not persuasive. Applicant pages 3-6 argue Cai nor Wang teaches administrating the claimed PARP inhibitor and temozolomide in the claimed daily range for at least one cycle, wherein one cycle comprises 28 consecutive days of administration of the PARP inhibitor and 21 consecutive days of administration of temozolomide. Additionally, Wang fails to teach the claimed PARP inhibitor and teaches towards an increase in temozolomide administration.
It is noted that the obviousness rejection was based upon a combination of teachings and the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See in re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Applicant is arguing each prior art individually, whereas the rejections was based off the combination of references. Thus, one cannot show nonobviosuness by attacking references individually whereas the rejections are based on combination references.
Cai teaches the claimed composition of the specific PARP inhibitor within the claimed range in combination with temozolomide to treat claimed cancers. The teachings of Wang show it is known in the art in a PARP inhibitor and temozolomide composition, the agents are administered within the claimed range. Wang furthermore teaches the administration of temozolomide for a much longer period at reduced dosage. For example, the temozolomide may be administered daily for 11 days to six weeks at a dosage of 20 to 120 mg/m2/day, thus providing motivation for a low dosage of temozolomide. Additionally, applicant has not shown unexpected results at one or more cycle over a 7-day administration. According to applicants’ specification (page 29) administration of the composition to be effective can be for at least 7, 14, 21 or 28 consecutive days.
For the reasons stated above the rejection of record over Cai et al. (WO 2012130166 A1) in view of Wang et al. (WO 2019015561 A1) is maintained.
Applicant has added claim 23. No new matter was added. Claims 1, 4-5, 7-11, 13, 18, 20, 22-23 is pending. Claims 1, 4-5, 7-11, 13, 18, 20, 22-23 is now evaluated on its merits.
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 1, 4-5, 7-11, 13, 18, 20, 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Cai et al. (WO 2012130166 A1) in view of Wang et al. (WO 2019015561 A1).
Regarding claims 1, 4-5, 7-11, 13-15, 18 and 20-23, Cai teaches a method for the treatment of cancers of the liver, melanoma, Hodgkin's disease, non-Hodgkin's lymphoma, acute lymphocytic leukemia, chronic lymphocytic leukemia, multiple myeloma, neuroblastoma, breast carcinoma, ovarian carcinoma, lung carcinoma, Wilms' tumor, cervical carcinoma (relevant to claim 10) (para. 0057) comprising a PARP inhibitor of Formula I, II or III in combination with at least one anticancer agent selected from cyclophosphamide, ifosfamide, temozolomide, bendamustine and cis-platin (relevant to claim 6) (para. 0061).
Cai teaches formula I:
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312
638
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(relevant to claim 1). Formula II:
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485
626
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194
651
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(relevant to claim 2). Formula III:
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489
648
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159
650
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(relevant to claim 4) (para. 0013-0018). Cai additionally teaches preferred compounds of Formulae I, II and III include, without limitation majority of the compounds of claim 5 of claimed invention (para. 0019) which includes 7-Fluoro- 1 -(3 -(4-(pyrimidin-2-yl)piperazine- 1 -carbonyl)benzyl)quinazoline-2,4( 1Η, 3Η)- dione and 5-Fluoro-1-(4-fluoro-3 -(4-(pyridin-2-yl)piperazine- 1 -carbonyl)benzyl)quinazoline- 2,4(lH,3H)-dione; (relevant to claim 5) (para. 0019).
Cai additionally teaches the compounds may be administered to mammals, orally at a dose of 0.0025 to 50 mg/kg of body weight, per day, and when the known anticancer agent is also administered, it is administered in an amount that is effective to achieve its intended purpose. The amounts of such known anticancer agents effective for cancer are well known to those skilled in the art (para. 0066). For topical formulation, the compound may be present at a concentration of approximately 0.01 to 100 mg per gram of carrier (relevant to claims 7-9, 14 and 23) (para. 0068).
Cai fails to teach the temozolomide at a daily dose of 10-30 mg, the composition administered for one cycle and in the form of a kit.
Wang teaches a method of treatment of solid cancers comprising the administration of a PARP inhibitor in combination with temozolomide (para. 0028). Wang additionally teaches the temozolomide administered at standard dosage schedule of 20mg – 120mg once a day, PARP inhibitor at 5-80 mg (para. 0037) and the composition being in form of a kit (para. 0033). Of the days administered Wang teaches the temozolomide may be administered for a much longer period at reduced dosage. For example, the temozolomide may be administered daily for 11 days to six weeks at a dosage of 20 to 120 mg/m2/day (para. 0100).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have administered the composition in kit form of the PARP inhibitor of formula III and temozolomide taught by Cai at the dosage amount and consecutive days of claimed invention to treat cancer. One would have been motivated to do so from the teachings of Cai of formula III administered at a dosage amount within the claimed dosage in combination with temozolomide and the teachings of Wang of a PARP inhibitor in combination with temozolomide to treat cancer, wherein the combination is in kit form and the dosage amount as well as administration time of the PARP inhibitor and temozolomide falls within claimed dosage amounts. There is a reasonable expectation of treating cancer comprising administration of the above formula III in combination with temozolomide in kit form, wherein formula III is administered at 20, 40, 60 or 80 mg and temozolomide is administered at 20-30 mg from the teachings of Cai and Wang. It would also be obvious to administer the temozolomide at lower dosage as suggested by Wang for a longer time period and of routine experimentation to test the proper dosage amounts to get the best desired results.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627