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 .
Detailed Action
Claims 19-20, 27, 32, 34-36 and 44-45 are withdrawn from consideration. Claims 1, 3, 5, 7, 9, 11, 15, 46, 63, 67 and 79 are pending and are now evaluated on its merit.
Priority
This application claims domestic benefit to U.S. provisional application 63/195,668, dated 06/01/2021.
Information Disclosure Statement
The information disclosure statement (IDS) dated 08/27/2024 and 11/12/2025 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
Election/Restrictions
Applicant’s election without traverse of claims 1, 3, 5, 7, 9, 11, 15, 46, 63, 67 and 79, drawn to a method of treating or preventing a disease or disorder alleviated by inhibiting Wnt/(3-catenin signaling, by activating adenosine monophosphate-activated kinase (AMPK) signaling, or by both inhibiting Wnt/3-catenin signaling and activating adenosine monophosphate- activated kinase (AMPK) signaling in a patient in need of said treatment or prevention, the method comprising administering a therapeutically effective amount of one or more compounds of
PNG
media_image1.png
126
206
media_image1.png
Greyscale
or a pharmaceutically acceptable salt thereof in the reply filed on 07/29/2026 is acknowledged. Claims 19-20, 27, 32, 34-36 and 44-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/29/2026.
Claim Rejections - 35 USC § 102
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 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 –
(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.
Claims 1, 3, 5, 7, 9, 11, 15, 46, 63, 67 and 79 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xue et al. (US 20190071424 A1).
Regarding claims 1, 3, 5, 7, 9, 11, 15, 46, 63, 67 and 79, Xue teaches a method for treating or preventing a disease or disorder alleviated by inhibiting the Wnt/β-catenin signaling pathway (para. 0005) comprising administration of formula II:
PNG
media_image2.png
135
273
media_image2.png
Greyscale
or a pharmaceutically acceptable salt thereof, and a physiologically compatible carrier medium (relevant to claims 46 and 63) (para. 0034)
PNG
media_image3.png
78
324
media_image3.png
Greyscale
PNG
media_image4.png
538
324
media_image4.png
Greyscale
. The disease or disorder may be selected from the group consisting of type 2 diabetes, obesity, hyperlipidemia, fatty liver disease, adrenocortical cancer, hepatocellular cancer, hepatoblastoma, malignant melanoma, ovarian cancer, Wilm's tumor, Barrett's esophageal cancer, prostate cancer, pancreatic cancer, bladder cancer, breast cancer, gastric cancer, head & neck cancer, lung cancer, mesothelioma, cervical cancer, uterine cancer, myeloid leukemia cancer, lymphoid leukemia cancer, pilometricoma cancer, medulloblastoma cancer, glioblastoma, and familial adenomatous polyposis (relevant to claim 67).
In some embodiments the treatment is of a combination composition comprising the above formula II and a therapeutically effective amount of an additional therapeutic agent selected from a RAF inhibitor, an MEK inhibitor, an ERK inhibitor, a VEGFR inhibitor, and an EGFR inhibitor (relevant to claim 79) (para. 0030). Of formula II, Xue teaches examples
PNG
media_image5.png
108
258
media_image5.png
Greyscale
,
PNG
media_image6.png
102
271
media_image6.png
Greyscale
,
PNG
media_image7.png
120
287
media_image7.png
Greyscale
,
PNG
media_image8.png
130
263
media_image8.png
Greyscale
(relevant to claims 1, 3, 5, 7, 9, 11 and 15) (Tables 1-2).
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, 3, 5, 7, 9, 11, 15, 63 and 67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 35-37 and 45-52 of copending Application No. 16/081,657 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-17, 35-37 and 45-52 of copending ‘657 anticipates and is obvious to claimed invention claims of treating or preventing a disease or disorder alleviated by inhibiting the Wnt/β-catenin signaling pathway comprising administration of compound
PNG
media_image9.png
134
283
media_image9.png
Greyscale
with all its limitations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 5, 7, 9, 11, 15, 63 and 67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-4, 6-10 and 31-37 of copending Application No. 19/249,712 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 3-4, 6-10 and 31-37 of copending ‘712 anticipates and is obvious to claimed invention claims of treating or preventing a disease or disorder alleviated by inhibiting the Wnt/β-catenin signaling pathway comprising administration of compound
PNG
media_image9.png
134
283
media_image9.png
Greyscale
with all its limitations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 5, 7, 9, 11 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13, 17 and 45-48 of U.S. Patent No. 11655233. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 13, 17 and 45-48 of U.S. ‘233 anticipates and is obvious to claimed invention of compound
PNG
media_image9.png
134
283
media_image9.png
Greyscale
with all its limitations of Ring A and R1-R3.
Claims 1, 3, 5, 7, 9, 11, 15, 63 and 67 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46-54 of U.S. Patent No. 12378220. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 46-54 of U.S. ‘220 anticipates and is obvious to claimed invention claims of treating or preventing a disease or disorder alleviated by inhibiting the Wnt/β-catenin signaling pathway comprising administration of compound
PNG
media_image9.png
134
283
media_image9.png
Greyscale
with all its limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKHAIL O'DONNEL ROBINSON whose telephone number is (571)270-0777. The examiner can normally be reached Monday-Friday 7:30am-5:30pm.
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 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
Prosecution Insights