DETAILED ACTION
Notice of Pre-AIA or AIA Status
1) 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 and Response to Restriction Requirement
2) Claims 7, 12, 18, 20, 22-23, 29, 31 and 36-39 are pending as of the response and amendments filed 05/15/2026. Claims 1-6, 8-11, 13-17, 19, 21, 24-28, 30 and 32-35 are cancelled. Applicant’s election of group I claims 7, 12, 18, 20, 22-23 and 36-39 without traverse is acknowledged. Claims 29 and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election of a species of compound, as those of examples 1, 2, 33, 34 and 38 is acknowledged. Claims 7, 12, 18, 20, 22-23 and 36-39 encompass the elected species. Claims 7, 12, 18, 20, 22-23 and 36-39 have been examined to the extent to which they are readable on the above identified elected species.
Because Applicant did not distinctly and specifically point out the supposed errors in the election of species requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The elected species was examined and was found to be free of prior art. Therefore, the examiner has extended the search to include the entire genus of compounds of Formula II as in claim 7. The compounds of Formula II are free of prior art. In view of the pending claims, the following rejections are made.
Priority
3) This application is a 371 of PCT/CN2021/126634 filed 10/27/2021 and claims foreign priority to CHINA 202110573594.5 filed 05/25/2021 and CHINA 202011519683.3 filed 12/21/2020.
It is noted that Applicants have not provided an English translation of the certified copy of the foreign priority applications as required by 35 U.S.C. 119(b)(3), 37 C.F.R 1.55(g)(1)-(4). Without the English translation, one cannot ascertain if the instant invention is supported in the foreign priority applications. Therefore, art prior to the PCT date, but not before the date of the Chinese application may be cited against the claims. See also MPEP § 216 for further details.
Information Disclosure Statement
4) The information disclosure statements submitted on 02/09/2026, 07/22/2025 and 07/21/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
C.F.R. 1.121
5) Claims 7, 12, 18, 20, 22-23 and 38-39 have not been provided by the proper claim markings that highlight the claim amendments in the claim set dated 05/15/2026 versus the previous preliminary amendment dated 04/03/2026. 37 C.F.R 1.121(c)(2) states “All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of "currently amended," and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of "currently amended," or "withdrawn" if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as "withdrawn— currently amended".”
See MPEP 714(II)(C) for further explanation of the amendment format required by 37 C.F.R 1.121.
Claim Objections
6) Claims 22 and 36-39 are objected to because of the following informalities:
In claim 22, line 1, the preamble should read “The compound of claim 7, …” (the limitation “claim” is missing).
In claims 36-39, line 1, the preamble should read “[[According to t]]The compound of claim 7, …” for consistency of claim language.
Appropriate correction is required.
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.
7) Claims 7, 12, 18, 20, 22-23 and 36-37 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.
Regarding claim 7, the claim recites Formula II with variables J, Y and T, that have not been defined in the claim, therefore causing some ambiguity regarding the scope of the claim.
Moreover, claim 7 defines the substituents in R2 and R3 to be the following at the beginning of the claim.
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The claim further has the following limitations towards the end of the claim for the substituents in R2 and R3.
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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 7 recites the broad recitation for the substituents in R2 and R3 at the end of the claim, and the claim also recites a narrower recitation of the substituents in R2 and R3 at the beginning of the claim, 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.
Therefore, the metes and bounds of claim 7 are indefinite.
For the purpose of applying prior art, claim 7 has been interpreted without the variables J, Y and T, and with ring A being
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; with the broader recitation of the substituents in R2 and R3 listed at the end of the claim.
Regarding claim 12, the claim recites “The compound of claim 7, wherein the compound is of formula III or formula IV …”. However, claim 12 does not recite a compound of formula III, rendering the scope of the claim indefinite.
For the purpose of applying prior art, claim 12 has been interpreted as “The compound of claim 7, wherein the compound is of [[formula III or ]]formula IV …”.
Claims 12, 18, 20, 22-23 and 36-37 are similarly rejected because they depend from the rejected base claim and do not remedy the indefiniteness.
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.
8) Claims 23 and 36 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.
Claim 23 depends from claim 7 and recites “The compound of claim 7, wherein R6 is hydrogen, or fluorine-substituted or non-substituted C1 to C4 alkyl”. However, claim 7 also recites R6 as hydrogen, or fluorine-substituted or non-substituted C1 to C4 alkyl. Claim 23 does not further limit the scope of claim 7, which is improper.
Claim 36 depends from claim 7 and recites “The compound of claim 7 (see claim interpretation in “Claim Objection” section above), wherein each occurrence of R7 is independently hydrogen, halogen, … -N(CH3)2, -N(CH2CH3)2), …
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…”. However, claim 7 does not support R7 being -N(CH3)2, -N(CH2CH3)2) and
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. This broadens the scope of the claim 36, which is improper.
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.
Allowable Subject Matter
9) The compounds of Formula II as in claim 7 are free of prior art. Except for the claim objections and 35 U.S.C. § 112(b) and 35 U.S.C. § 112(d) rejections above, all claims would be allowable.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record is Law et al. (US 2020/0338072 A1, 29 October 2020, hereinafter Law, in the IDS) and Xie et al. (US 2022/0340565 A1, PCT filing date of 02 December 2020, hereinafter Xie) (Xie qualifies as 35 U.S.C. 102(a)(2) prior art).
Law teaches the use of olorofim, 2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N-(4-(4-(5-fluoropyrimidin-2-yl)piperazin-1-yl)phenyl)-2-oxoacetamide in the prevention and treatment of a fungal infection caused by a Coccidioides species (Abstract; Para. [0001]).
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Olorofim of Law falls within the scope of Formula II of instant claim 7, wherein
R2 is C1 alkyl (methyl);
R3 is C1 alkyl (methyl);
R4 is hydrogen;
L is a bond; R5 is non-substituted phenyl;
R6 is hydrogen;
Z1 is CR8, R8 is hydrogen;
R24 is hydrogen;
Ring B is substituted 6-membered heteroaryl (pyrimidinyl);
n2 is 1; R7 is a halogen (fluoro).
Olorofim of Law differs from the instant compounds in the absence of a fused tricyclic ring.
Xie teaches pyrrole compounds of general formula (1) with variables as defined, for use in the prevention or treatment of diseases related to fungal infection (Abstract; Paras. [0006]-[0015]).
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Xie teaches the following exemplary compound, compound 1 (Para. [0023]).
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Compound 1 of Xie falls within the scope of Formula II of instant claim 7, wherein
R2 is C1 alkyl (methyl);
R3 is C1 alkyl (methyl);
R4 is hydrogen;
L is a bond; R5 is non-substituted phenyl;
R6 is hydrogen;
Z1 is CR8, R8 is hydrogen;
R24 is hydrogen;
Ring B is substituted 6-membered heteroaryl (pyrimidinyl);
n2 is 1; R7 is a halogen (fluoro).
Compound 1 of Xie differs from the instant compounds in the ring A being
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versus the instantly claimed
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.
The novelty of the instant compounds lies in the tricyclic fused ring containing the
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as the middle ring, which is not taught or suggested by the prior art.
Therefore, the instant compounds are novel and non-obvious various variants of the compounds taught in the prior art.
Conclusion
Claims 7, 12, 18, 20, 22-23 and 36-37 are rejected.
Claim 22 and 36-39 are objected to.
No claims are allowed.
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/PADMAJA S RAO/Examiner, Art Unit 1627
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