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 .
Current Status
This action is responsive to the amended claims of 12/04/2023. Claims 1-3, 5, 7-8, 10-11, and 14-24 are pending. Claims 7, 16-17, and 19-24 have been withdrawn. Claims 1-3, 5, 8, 10-11, 14-15, and 18 have been examined on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-3, 5, 7-8, 10-11, 14-15, and 18) and the species compound 1
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in the reply filed on 05/19/2026 is acknowledged.
A search for the elected species retrieved prior art. The search was also retrieved art for the following species:
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. Thus, the search will not be unnecessarily extended to further species in this action, per Markush search practice.
The elected species and the second species
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both read on claims: 1-3, 5, 8, 10-11, 14-15, and 18.
Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/19/2026.
Claims 16-17 and 19-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/19/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 06/02/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/04/2023, 02/06/2026, and 05/19/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 3-5, 8, 14-15, and 18 are objected to because of the following informalities. Appropriate correction is required.
Claims 3-5, 8, and 15: the amendments are not rendered in black text, so they are faint and pixelated making them difficult to read. Please render all future amendments in true black text.
Claim 14 recites
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. It is understood that the annotated N and O would naturally be protonated; however, it is preferred if each H is explicitly shown in the structure. Dependent claim 18 is similarly objected since it does not rectify this issue. Please provide an replacement structure containing the appropriate H.
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.
Claims 3, 8, and 11 are 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 3 recites the limitation ring A is selected from “
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”. There is insufficient antecedent basis for this limitation in the claim. The two cycles are 8-membered cycloalkyl and 8-membered cycloalkenyl. Parent claim 2 only allows for ring A to be chosen from 5-7 membered cycloalkyl and 5-7 membered cycloalkenyl; not 8 membered. While ring A may be substituted by alkyl groups, the claims do not recite wherein two substituents join to form a bridge. Thus, these cycles are outside of the scope of parent claim 2. Therefore, the metes and bounds of the claim are undefined rendering the claim indefinite.
To overcome: Applicant could either strike these rings from claim 3 or amend claim 2 to recite 5-8 membered cycloalkyl and 5-8 membered cycloalkenyl (claim 1 provides support for 5-12 membered ring A).
Claims 8 and 11 recite the limitation R5 is optionally substituted with “3-7 membered cycloalkyl-substituted C1-6 alkyl” and “3-7 membered cycloalkylsulfonyl”. There is insufficient antecedent basis for this limitation in the claims.
The “3-7 membered cycloalkyl-substituted C1-6 alkyl” is understood as an alkyl substituted with the 3-7 membered cycloalkyl; parent claim 1 recites R5 is optionally substituted with C1-6 alkyl which may be further substituted with 3-6 membered cycloalkyl – not a 7 membered cycloalkyl.
The “3-7 membered cycloalkylsulfonyl” encompasses: (1) sulfonyl substituted by a 3-7 membered cycloalkyl and (2) a 3-7 membered cycloalkyl substituted by a sulfonyl. Parent claim 1 allows when R5 is substituted with sulfonyl (1), the sulfonyl may be further substituted by a 3-6 membered cycloalkyl – not a 7 membered cycloalkyl. Further, when R5 is substituted by 3-7 membered cycloalkyl (2), this ring may be further substituted but the further substituents do not include sulfonyl.
These combinations of R5 substituents are not supported by the scope of parent claim 1. Thus, the metes and bounds of the claims are undefined rendering the claims indefinite.
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.
Claims 3, 8, and 11 are 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. Claims 3, 8, and 11 recite chemical moieties which are not within the scope of their respective parent claims: 2, 1, and 1. See ¶16-17 for the chemical moieties which are outside of the parent claims’ scopes. Thus, the claims 3, 8, and 11 do not properly further limit their parent claims 2, 1, and 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 § 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)(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.
Claims 1-3, 5, 8, 10-11, 14-15, and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by YU (WO 2022/135567; effectively filed 28 May 2021; provided IDS of 12/04/2023). A machine translation is relied upon for the text portions of the document and is attached. References to structures and figures are to the original document. The priority document is cited as “PD”.
Regarding claims 1-3, 5, 8, 10-11, and 14, YU teaches compound 3
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and salts thereof (Pg. 41; PD Pg. 26 claim 92) wherein:
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R1 and R2 form ring A which is phenyl, R3 is (C1-6alkylene)0-NR4R5, R4 is H, R5 is 6 membered heterocycle substituted by a C1 alkyl, Y is phenyl substituted with 2 substituents selected from hydroxyl and haloC1alkyl. Alternatively, the second substituent on Y (-CF3) falls under a C1alkyl further substituted by 3 halogens. This is the same compound as that recited in instant claim 14 (Pg. 13) row 4 column 2.
Regarding claims 15 and 18, YU further teaches a pharmaceutical composition comprising the compound or salts thereof and at least one pharmaceutically acceptable carrier or excipient (Pg. 180 ¶253; PD Pg. 27 claim 94).
Further, YU teaches many other compounds which fall under the scope of instant Formula (I) claim 1:
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(Pg. 97 claim 59; PD Pg. 25-26 claims 91-92) and
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(Pg. 29; PD Pg. 25-26 claims 91-92). The compounds above are mapped onto Formula (I) in the same manner as compound 3: e.g.,
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. The above species, each, also fall under one or more of instant claims 2-3, 5, 8, and 10-11 by this mapping. The above compounds:
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,
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, and
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match 3 species recited in instant claim 14. Since YU also teaches pharmaceutical compositions (above), instant claims 15 and 18 are also met.
Claims 1-3, 5, 8, 10-11, 14-15, and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by HUANG (US 2024/0391881; effectively filed 30 Sept. 2021; cited IDS of 05/19/2026). The priority document is cited as “PD”.
Regarding claims 1-3, 5, 8, 10-11, and 14, HUANG teaches compound 40
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(Pg. 42 Example 40; PD Pg. 9 compound 40) R1 and R2 form ring A which is phenyl, R3 is (C1-6alkylene)0-NR4R5, R4 is H, R5 is 6 membered heterocycle substituted by a C1 alkyl, Y is phenyl substituted with 2 substituents selected from hydroxyl and C1alkyl. This is the same compound as that recited in instant claim 14 (Pg. 18) row 1 column 1.
Regarding claims 15 and 18, HUANG teaches a pharmaceutical composition comprising the above compound and/or salts thereof and a pharmaceutically acceptable excipient (Pg. 15 ¶108; PD Pg. 12 claim 9).
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Note: a certified translation of the earliest dated priority document would overcome the HUANG rejection and would avoid application of other prior art references with intervening effectively filed dates, as long as the instantly claimed subject matter is supported by the priority document.
Conclusion
Claims 1-3, 5, 8, 10-11, 14-15, and 18 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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