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 .
Claims 1 and 2 have undergone amendments. Claims 234 and 235 are newly added. Thus, Claims 1-2, 5-6, 10, 14, 22, 24, 31-32, 36-37, 41, 45-46, 48, 50, 52-53, 69, 77-79, 84, 90, 92-94, 106, 108, 123, 130, 208-209, 211, 216, 219, and 232-235, submitted on 14 May 2026, represent all claims currently under consideration.
Election/Restrictions
Claim 1 is allowable. A complete search of Claim 1 was performed in the prior office action, and Applicant has amended Claim 1 to overcome the prior rejections (See STN Search, Search Notes). Claims 6, 22, 24, 31-32, 45-46, 48, 50, 52, 84, and 108, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement between inventions species, as set forth in the Office action mailed on 25 February 2025, is hereby withdrawn and claims 1-3, 5-6, 13, 17-19, 29, 30, 32-34, 40, 42, 44, 46, 50, 52, 54, and 113-119 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Response to Amendment
The 35 U.S.C. § 112(d) rejection of Claim 2 is withdrawn. Applicant has amended Claim 2 to recite that the compound is of Formula (I-i), and added two new claims which contain the other two structures, placing the claim in proper dependent format.
The 35 U.S.C. § 102(a)(1) rejection of Claims 1, 2, 5, 53, 69, and 106 over STN RN 1625006-74-7 is withdrawn. Applicant has amended Claim 1 to remove -NO2 as a variable group for R1, obviating the rejection.
The 35 U.S.C. § 102(a)(1) rejection of Claims 1, 2, 53, and 106 over STN RN 1625055-06-2 is withdrawn. Applicant has amended Claim 1 to remove -NO2 as a variable group for R1, obviating the rejection.
Claim Objections
Claim 130 is objected to because of the following informalities: The Claim is directed to several compounds, “and pharmaceutically acceptable salts, hydrates, solvates, polymorphs, co-crystals, tautomers, stereoisomers, isotopically labeled derivatives, and prodrugs thereof”, indicating that the claim is directed towards multiple compounds. The Examiners suggests amending the final limitation to read “or a pharmaceutically acceptable salt, hydrate, solvate, polymorph, co-crystal, tautomer, stereoisomer, isotopically labeled derivative, or prodrug thereof”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)- NEW GROUNDS OF REJECTION
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 22 depends on Claim 1, with Claim 1 stating that variable L1 is selected from optionally substituted C1-C6 alkylene, optionally substituted C2-C6 alkenylene, optionally substituted carbocycle, optionally substituted arylene, or optionally substituted heteroarylene. Claim 22 then claims that variable L1 is selected from optionally substituted C1-C6 alkylene, optionally substituted C2-C6 alkenylene, optionally substituted arylene, or optionally substituted heteroarylene; or optionally substituted carbocycle or optionally substituted heterocyclyl. Claim 1 does not claim that variable L1 can be an optionally substituted heterocycle, causing the claim to be broader than Claim 1, and the other options for variable L1 are identical to those which are claimed in Claim 1, causing the claim to not further limit Claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(b)- NEW GROUNDS OF REJECTION
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 84 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. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 84 recites the broad recitation wherein variable R1 is heterocycyl, and the claim also recites wherein variable R1 is morpholinyl or variable R1 is piperidinyl, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Allowable Subject Matter
Claims 1-2, 5-6, 10, 14, 31-32, 36-37, 41,53, 69, 77-79, 90, 92-94, 106, 108, 123, 208-209, 211, 216, 219, and 232-235 are allowed.
Claim 84 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 130 is objected to, but otherwise allowable.
Claims 24, 45, 46, 48, 50, and 52 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: There is no prior art which teaches, suggests, or provides motivation for the compounds of the examined application (See STN Search, Search Notes). The closest prior art comes from Kumar (WO 2005/097746; Publication Date: 20 October 2005), Shima (US 2004/0097425; Publication Date: 20 May 2004), and Deschenes (WO 2012/154518; Publication Date: 15 November 2012). Each of these references discloses compounds of similar structure to those of the examined application, and are useful for the treatment of cancers. However, these compounds are structurally distinct from those the examined application, and there is no teaching, suggestion, or motivation found within these references to modify the compounds to arrive at the compounds claimed in the examined application.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Claims 1-2, 5-6, 10, 14, 31-32, 36-37, 41,53, 69, 77-79, 90, 92-94, 106, 108, 123, 208-209, 211, 216, 219, and 232-235 are allowed.
Claim 130 is objected to, but otherwise allowable.
Claims 24, 45, 46, 48, 50, and 52 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 22 and 84 are rejected.
THIS ACTION IS MADE FINAL. 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 PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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, Andrew Kosar can be reached at 571-272-0913. 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.
/P.M.R./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
Prosecution Insights