DETAILED ACTION
The Examiner inherited this application from another.
Notice of Pre-AIA or AIA Status
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
3. 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 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.
Continued Examination Under 37 CFR 1.114
4. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/15/2025 has been entered.
Priority
5. This application is a 371 of PCT/SG2021/050009, international filing date: 01/08/2021, which claims foreign priority to a Singapore patent application #: 10202000183R, filed on 01/08/2020.
6. The perfecting foreign priority date: 01/08/2020.
Current Status of 17,791,571
7. Amended claims 2, 6, 7, 10-13 and 17-21 have been examined on the merits. Claims 17-21 are new. Claims 2 and 7 are currently amended. Claims 6 and 10-13 are previously presented. Claims 1, 3-5, 8, 9 and 14-16 have been canceled.
Information Disclosure Statement
8. The information disclosure statement (IDS) and the supplemental Information Disclosure Statement under 37 CFR 1.56 submitted on 12/15/2025, were filed before the mailing of a first Office action after the filing of a RCE. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
9. The Examiner acknowledges receipt of Applicants’ claim amendments and Reply
of December 15, 2025.109. The Examiner has reviewed the claim amendments and Reply of 12/15/2025.
11. In the reply of 12/15/2025, Applicants argue that the combination of the cited references of HO, CHALMARS, SENRA, FONG and NICHOLAS does not suggest the claimed invention of a combination of compound of Formula (I) and Olaparib for treating pancreatic cancer, ovarian cancer or cholangio-carcinomas or the combination has a synergistic effect, from the standpoint of combination of a compound of Formula (I) (a Wnt inhibitor) and Olaparib (a PARP inhibitor).
The obviousness rejections are withdrawn given Applicants’ persuasive traversal regarding synergy being unexpected. In addition, Applicants have demonstrated within page 11 of their 15 Dec 2025 Remarks and within their Specification to be unexpected and certainly not predictable. Moreover, synergistic results can be considered unexpected. Synergism is evidence of non-obviousness.
Thus, the obviousness rejections are withdrawn.
Response to Amendment
Objection to Specification
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. §112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. § 112. Examples of some unclear, inexact or verbose terms used in the specification are:
11. There are wrong structures of formula(I) drawn (see the picture below on the left) in the Specification (on pages 3, 4 and 10) and in claims 2 and 7.
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The wrong structure The correct structure on page 31
The drawing of formula (I) is incorrect with a single bond between the two red arrows. It should be a DOUBLE bond there. It even causes more confusions that the wrong structures are present in claims and Specification of the present application while there is a correct structure drawn on page 31 of the Specification (shown on the right).
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the wrong structures in claims and specification of the present application.
Claim Objections
12. Claims 2 and 7 are objected to because of the following informalities: the wrong structure of compound of formula (I) described in the above “specification” section (Section 11).
Appropriate correction (changing the single bond to a double bond) is required.
Claim Rejections - 35 USC § 112
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.
13. Claims 2, 6, 10-13 and 17-19 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.
The phrase “including the step of” renders the metes and bounds of the claim 2 undefined (hence rendering claim 2 indefinite). The artisan is not certain if the step(s) following “including” are merely exemplary or are required limitations of the claim.
Claims 6, 10-13, 17-19 are similarly rejected as indefinite since these claims refer back to claim 2 but do not remedy the rationale underpinning the basis for rejecting claim 2.
Please strike “including the step of” from claim 2 and other claims to render moot this rejection.
Conclusion
14. Claims 2, 6, 10-13 and 17-19 are rejected.
15. Claims 7 and 20-21 are objected to.
16. Claims 2 and 7 are free of the prior art.
17. A close, but not prior art is YAMAMOTO (Yamamoto, et al “Activation of Wnt signaling promotes olaparib resistant ovarian cancer”, Molecular Carcinogenesis 2019;58:1770-1782, referenced in IDS of 07/08/2022 and provided by Applicants).
YAMAMOTO discloses a combination of pyrvinium pamoate and olaparib results in a significant decrease in tumor burden in both a cell line and a xenograft model in an effort to overcome drug resistance problem. This study demonstrates that Wnt signaling can mediate poly(ADP)-ribose polymerase inhibitors (PARPi) resistance in high grade serous ovarian carcinoma (HGSOC) and provides a clinical rationale for combining PARP and Wnt inhibitors.
The instant application differs from the close art of YAMAMOTO mainly in (1). They use different combinations of compound of formula I and Olaparib for the instant application vs. of pyrvinium pamoate and Olaparib for the close art; (2). They cover different scopes of cancers treated - pancreatic cancer, ovarian cancer and cholangio-carcinomas for the instant application vs. ovarian cancer for the close art.
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/B.T./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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