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 the Claims
Claims 1, 4-9, 11-13 and 16-21 are currently pending. Claims 7-9 and 16-21 are withdrawn. Claims 1, 4-6 and 12-13 are rejected. Claim 11 is allowed.
Response to Amendment/Arguments
The amendment filed October 28, 2025 is compliant with the requirements of 37 CFR 1.121(c), accordingly the amendment has been entered.
Applicant’s arguments have been fully considered and are addressed below:
Objection to the Specification
The objection of the specification for typographical errors has been overcome by the amendment correcting the typographical errors. The objection has been withdrawn.
Objection to the Claims
The objection of the claims 1, 2 and 6 for informalities has been overcome by the amendments to claims 1 and 6 and cancellation of claim 2. The objection has been withdrawn.
35 USC § 112 Rejections
The rejection of claim 11 under 35 USC 112(d) has been overcome by rewriting the claim in independent form. The rejection has been withdrawn.
35 USC § 102 Rejections
The anticipation rejection of:
claims 1-6 and 11-13, over Zhu et al. US 2023/0322769 A1 (earliest priority date: Aug. 20, 2020) as evidenced by Brayton, C. F. Cornell Vet. 1986, 76, 61-90, and
claims 1-6 and 11-13, over Wang et al. WO 2020/200316 A1 (pub. Oct. 8, 2020; earliest priority date: Apr. 3, 2019) as evidenced by its English equivalent US 2022/0220104 A1, and as further evidenced by Dorokhov et al. Physiol. Rev. 2015, 95, 603-644 and Brayton, C. F. Cornell Vet. 1986, 76, 61-90
have been overcome by narrowing the scope of “B”, in formula I
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, to exclude R10 and R11 from joining together to form a ring, when B is -NR10R11. This circumvents Zhu’s and Wang’s compounds wherein instant B is a heterocyclic ring, such as Zhu’s compound 66,
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, and Wang’s compounds
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,
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and
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. The rejection has been withdrawn.
Restriction/Election
In accordance with the MPEP 803.02 and as necessitated by amendment, examination of the Markush-type claims has been extended, beyond the elected species
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, to non-elected species encompassed by claim 11 and by formula (I)
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, wherein:
A is CN,
B is -O-(L1)m1-R8, L1 is -CRfRg-, Rf and Rg are H, m1 is 2, R8 is unsubstituted 7- or 10-membered fused heterobicyclic ring, or
B is -NR10R11, R10 and R11 are selected from H and unsubstituted C3 alkyl,
X1 and X2 are N,
n is 1, and
Z is methoxy.
Claim 11 was found allowable. However, non-elected species within the aforementioned subgenus were not found allowable over the prior art; therefore, the search has not been further extended. Claims 7-9 and 16-21 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.
Priority
This application is a 371 of PCT/CN2020/135934, filed on 12/11/2020, and claims priority to CN 201911266900.X, filed on 12/11/2019. On 10/28/2025, Applicant filed an English translation of the CN foreign application; thereby, perfecting the claim for foreign priority. The effective filing date of the claims is 12/11/2019.
Claim Objections
Claim 1 is objected to because the Markush grouping of R10 and R11 ends with a “wherein” clause defining “substituted”, which clause contains a Markush grouping of alternative substituents. The last two substituents are not separated by “and”. This objection may be overcome by inserting “and” as indicated below:
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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.
(1 of 2) Claims 1, 4, 5 and 12-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Xie et al. WO 2021/043209 A1 (earliest priority date: May 14, 2019) as evidenced by an English machine translation thereof (obtained on Aug. 11, 2026 from https://worldwide.espacenet.com).
Xie et al. teach a pharmaceutical composition comprising a compound of claim 20, such as compound 1,
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, or compound 2,
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, “and a pharmaceutically acceptable excipient.” Xie (transl.) 25, claim 21. Several anticipatory compounds/compositions are disclosed in claim 21 and are too numerous to list. The composition comprising compound 1 or 2 anticipates the claimed embodiment outlined below:
Claims 1, 4, 5 and 12-13 with respect to formula I
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, wherein:
A is CN,
B is -O-(L1)m1-R8, L1 is -CRfRg-, Rf and Rg are H, m1 is 2,
R8 is unsubstituted 7- or 10-membered fused heterobicyclic ring,
X1 is CH, X2 is N,
n is 1, and
Z is methoxy.
(2 of 2) Claims 1, 6 and 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hong et al. WO 2021/088911 A1 (earliest priority date: Nov. 8, 2019) as evidenced by an English machine translation thereof (obtained on Aug. 11, 2026 from https://patentscope.wipo.int/).
Hong teaches a compound of formula (I),
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, and a pharmaceutical composition thereof “and a pharmaceutically acceptable carrier”. See, e.g., Hong (transl.) para. 9, 10 and 73. Hong teaches compound I-7,
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, as a species of formula (I). See, e.g., Hong (transl.) para. 183 and 290. The composition comprising compound I-7 anticipates the claimed embodiment outlined below:
Claims 1, 6 and 12-13 with respect to formula I
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, wherein:
A is -CN,
B is -NR10R11, R10 and R11 are selected from H and unsubstituted C3 alkyl,
X1 is CH, X2 is N,
Z is unsubstituted C1-alkoxy, and
n is 1.
Allowable Subject Matter
Claim 11 is allowed. The closest art is cited above.
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 extension fee 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 date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L AGUIRRE whose telephone number is (571)272-5592. The examiner can normally be reached 10 am-6 pm MST.
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/AMANDA L. AGUIRRE/ Primary Examiner, Art Unit 1626
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