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 .
Status of Claims
Claims 1, 4, 11-16, 18, 20, 23, 27, 43, 48, 51, 54, 59, and 61 are pending.
Priority
Instant application 17/916,773, filed 10/03/2022 claims priority as follows:
PNG
media_image1.png
47
645
media_image1.png
Greyscale
PNG
media_image2.png
32
642
media_image2.png
Greyscale
Information Disclosure Statement
All references from IDS(s) received 05/21/2025, 04/12/2024, 01/25/2024, and 03/28/2023 have been considered unless marked with a strikethrough.
Response to Amendment/Arguments
The amendment filed 1/30/2026 has been entered. Applicant has amended claims 1, 4, 11-13, 15, 18, 20, 23, 48, 51, 54, and 59. Claims 2, 3, 5-10, 17, 19, 21, 22, 24-26, 28-42, 44-47, 49, 50, 52, 53, 55-58, 60, and 62 have been cancelled.
In view of the amendment to the claims, applicant has overcome the objection to claim 59 and claim 9; and the rejections under sections 112(b), 112(d), 102, and 103 previously raised in the Non-Final action dated 10/01/2025. Therefore, the previous objections and rejections are withdrawn.
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.
Claim 59 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 59 depends from claim 1, but recites multiple compounds which do not read on formula (I) in claim 1. For example, formula (I) requires that each of R3 and R4 is independently optionally substituted C1-6 alkyl or halogen, but claim 59 recites compounds where R3 is H. See, for example:
PNG
media_image3.png
229
692
media_image3.png
Greyscale
Note that there are many more compounds with this issue. Applicant is invited to review the entirety of claim 59 to ensure that the compounds fall within the scope of formula (I) in claim 1.
There is insufficient antecedent basis for these limitations in the claim.
Double Patenting - Maintained
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, 4, 11-16, 18, 20, 23, 27, 43, 48, 51, 54, 59, and 61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11, 14, 18, 34, 39, 42, 45, 50-52, and 54-58 of copending Application No. 17/916,760 (reference application).
The reference application recites compounds of formula (I) instantly claimed and pharmaceutical compositions thereof. The utility disclosed for the compounds claimed in the reference application may be found, for example, in the “Field of the Invention” section of the specification (ref. application, page 1), which states:
PNG
media_image4.png
113
570
media_image4.png
Greyscale
Moreover, new claim 58 (filed 01/27/2026) recites:
PNG
media_image5.png
51
631
media_image5.png
Greyscale
Accordingly, it would have been prima facie obvious to administer the compounds claimed in the reference application to a subject having cancer, in particular cancers that harbor CCNE1 amplification/overexpression or FBXW7-mutated cancers, in order to treat the cancer in that subject.
This rejection is proper according to MPEP 804(II)(B)(1):
Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970)…The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003)…In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to arguments
In the remarks filed 01/30/2026, applicant stated:
PNG
media_image6.png
105
626
media_image6.png
Greyscale
The rejection is still deemed proper and is therefore maintained.
Close prior art cited but not applied
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. BLAZQUEZ (WO 2015144923 A1; cited in IDS) represents close prior art. BLAZQUEZ discloses compounds characterized by general formula (1) useful for treating cancer, wherein R1 is OH or CH2OH (abstract):
PNG
media_image7.png
436
582
media_image7.png
Greyscale
In particular, the closest compound disclosed by BLAZQUEZ is compound 2 (page 6, line 1). The difference between BLAZQUEZ the instant claims is that the compounds in BLAZQUEZ comprise an additional fused ring. See the comparison below:
BLAZQUEZ
Application No. 17/916,773
PNG
media_image7.png
436
582
media_image7.png
Greyscale
PNG
media_image8.png
200
176
media_image8.png
Greyscale
PNG
media_image9.png
408
528
media_image9.png
Greyscale
PNG
media_image10.png
169
203
media_image10.png
Greyscale
The prior art fails to teach, suggest, or otherwise provide any motivation for modifying the compounds in BLAZQUEZ to arrive at a compound useful for treating a cancer overexpressing CCNE1 or having an inactivation mutation in the FBWX7 gene.
Conclusion
Claims 1, 4, 11-16, 18, 20, 23, 27, 43, 48, 51, 54, 59, and 61 are rejected.
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 Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 pm.
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, Clinton Brooks can be reached at (571) 270-7682. 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.
/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights