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 .
Claim Status
Claims 1-11 and 13-16 are pending. Claims 3-8 and 13-15 are rejected. Claims 1-2, 9-11 and 16 are allowed.
Response to Arguments/Amendments
Applicant’s amendments have overcome the previously presented rejections.
Regarding the previously filed IDS forms, Applicant states that the search documents were not cited in the IDS as the Non-Patent Literature Documents section did not seem to be the appropriate place for patent application related search documents. However, these documents are generally cited in the Non-Patent Literature Documents section of the form. For example, documents of this type can be cited in the manner shown below:
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Information Disclosure Statement
The information disclosure statements filed 11/19/2025, 11/04/2025, 10/31/2025, 09/29/2025, and 09/13/2023 fail to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. The information disclosure statement has been placed in the application file, but the information referred to therein has not been considered.
The IDS filed 11/19/2025 appears to be blank and the forms filed 11/04/2025, 10/31/2025, 09/29/2025, and 09/13/2023 fail to list the patent application related search documents that were submitted.
Priority
Receipt is acknowledged of the certified translation of foreign priority document CN202110439238.4. For the purposes of examination, the earliest priority date for claims 1-11 and 13-16 is April 22nd, 2021.
Claim Rejections - 35 USC § 112
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 8 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 8 recites the following compound which is beyond the scope of independent claim 7:
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Claim 7 requires that at least one of X1 and X2 is N.
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 § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 3-8 and 13-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2022/225934 A1 by Trzoss et al. which claims priority to U.S. Provisional 63/176,610 filed April 19th, 2021.
Regarding instant claims 3-4, the prior art discloses compound 61 on page 65 and the following compounds on page 78 (page 73 of ‘610):
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The compounds above read on the first three compounds of instant claim 4 and are embraced by instant formula (2) where R1 is C2 alkyl, where R2 is H, R7 is C1 alkyl, and i) one of X3 and X4 is CH, the other is N, X5 is CR6 and R6 is H, or ii) X3 and X4 are both CH and X5 is N.
Regarding instant claims 5-6, the prior art compound discloses compounds 20-21 on pages 59-60 and the following compound on page 85 (page 53 of ‘610):
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Compounds 20 and 21 read on the following compound of claim 6 which is embraced by instant formula (3) where R1 is C2 alkyl, R3 is H and R7 is C1 alkyl :
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The following compound is identical to compound 6 of claim 6 which is embraced by instant formula (3) where R1 is C3 cycloalkyl, R3 is H and R7 is C1 alkyl:
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Regarding instant claims 7-8, the prior art discloses the following compound page 80 (page 91 of ‘610):
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The compound is identical to compound 2 of claim 8 and is embraced by general formula (4) where R1 is C2 alkyl, X1 is CH, X2 is N, R2 is H, R3 is H, and R7 is C1 alkyl.
Claim 8 has been rejected under 35 USC 112d with regards to compound 3; however, the compound is anticipated by the prior art on page 83 (page 45 of ‘610):
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The prior art further teaches a composition comprising the compounds above and a pharmaceutically acceptable excipient in accordance with instant claims 13-15 (paragraph [00267]; paragraph [00196] of ‘610).
Allowable Subject Matter
Claims 1-2, 9-11 and 16 are allowed.
The closest prior art for these claims is WO 2022/225934 A1 by Trzoss et al. which claims priority to U.S. Provisional 63/176,610 filed April 19th, 2021. The prior art discloses the following compound which reads on compound 1 of claim 2 and is embraced by instant formula (1) where X1 is CH, X2 is N, R1 is C2 alkyl, R2-R5 are H, and n is 1 (page 67):
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However, the reference does not have support for the compound in the earliest priority document filed.
The compound below has a core structure that is analogous to compounds of formula (1) where X1 is CH and X2 is N, R1 is C3 cycloalkyl, R2 is C1 alkyl and R3 is H but lacks the cycloalkyl ring on the amide (page 85; page 53 of ‘610):
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The prior art does not disclose any compounds with priority to provisional ‘610 that possess this feature.
Regarding instant claims 9-10 and 16, compound 20 is one of the closest structures (page 85; page 53 of ‘610):
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The compound above is analogous to a compound of formula (5) where R1 is C2 alkyl, R3 is H and R7 is C1 alkyl but does not have the bicyclic core structure required by instant formula (5) where X6 is CR9R10. Furthermore, the compound has an additional substituent on the linker that connects the piperazine with the bicycle that is not provided for in the instant genus. Trzoss et al. provide no motivation or guidance for modifying the compounds recited above in a manner that would result in compounds embraced by the instant claims. Therefore, the prior art neither anticipates nor renders obvious the instant claims.
Conclusion
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 ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at (571)272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626