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 .
Priority
The present application claims priority to the applications, CN 2021/10412189.5 and PCT/CN2022/087226, with the effective filing dates of 16 April 2021 and 15 April 2022, respectively.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claim Status
This Office Action is in response to Applicant’s Response to Restriction Requirement filed, 25 March 2026.
Applicant’s election with traverse of Group I (claims 1-15 and 17-18) and
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in the reply filed on 25 March 2026 is acknowledged. The traversal is on the ground(s) that the generic claims are not so broad as to place an undue burden on the Patent Office to search and examine the full scope of the claims.
However, this is not found persuasive, because Applicant did not explicitly point out why the finding of lack of unity is improper for a National Phase (371) application. Further, Applicant applies a different standard to traverse the restriction requirement, which is irrelevant to National Phase (371) applications. Additionally, Applicant has not established that the claimed invention provides a contribution over the cited prior art in the Restriction Requirement mailed on 26 January 2026. Thus, the requirement is still deemed proper and is therefore made FINAL.
Claims 3, 7, 9, and 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Claim 3 specifies wherein each Rb is independently selected from the group consisting of F, CH3, CH2CH3, OCH3, OCH2CH3, -OCH2(CH3), -C(=O)CH3, -C(=O)CH2CH3, SCH3, SCH2CH3, S(=O)CH3, and S(=O)CH3, which does not read on the elected species. Claim 7 specifies R2 and R4 together with the atom linked thereto form oxa-cyclopbutyl, oxa-cyclopentyl, oxa-cyclohexyl, aza-cyclobutyl, aza-cylcopentyl, and aza-cyclohexyl, which does not read on the elected species. Claim 9 specifies R6 is selected from the group consisting of F and CN, which does not read on the elected species. Claim 17 specifies a compound of Formula (P), which does not read on the elected species. Claim 18 specifies a compound of Formula (P), which does not read on the elected species.
Claims 16 and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group (Group II), there being no allowable generic or linking claim.
Claims 1-2, 4-6, 8, and 10-15 are under examination in the instant office action.
Information Disclosure Statement
The Information Disclosure Statements filed on 10 Jan 2024 and 8 Aug 2025 and the references cited therein have been considered, unless indicated otherwise.
The references, wherein a copy was not provided, are lined through. These references are the following: WO 2015/009616.
Additionally, the Third-Party Submission filed 20 Jan 2025 and the references cited therein have been considered, unless indicated otherwise.
Claim Interpretation
For purposes of clarity, the Examiner interprets claims 1 and 2 to require one of 1) R2 and R3 or 2) R2 and R4 to be a 3- to 6-membered heterocycle.
Claim Suggestions
The Examiner respectfully suggests Applicant amend claims 12-13 from “wherein the compound is as follows” to “wherein the compound is selected from” in order to be consistent with the language in other claims that recite alternatives (e.g. claims 14-15).
Claim Objections
1. Claims 13-15 are objected to because of the following informalities: lack of a comma and/or conjunction to separate the options. Claim 13 recites that the compound is as follows:
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, but claim 13 does not separate the options via commas or recite a conjunction (i.e. “and” or “or”). Similarly, claims 14 and 15 do not separate the options via commas or recite a conjunction.
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.
2. Claims 1-2 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 1 recites two conditional phrases, (1) “when R2 and R3, together with the atom linked thereto, form 3- to 6-membered heterocyclyl, wherein the 3- to 6- membered heterocyclyl is optionally substituted with 1, 2, or 3, Rb, R4 is selected from the group consisting of H, halogen, C1-3 alkyl, and C1-3 alkoxy…” and (2) “when R2 and R4, together with the atom linked thereto, form 3- to 6-membered heterocyclyl, wherein the 3- to 6- membered heterocyclyl is optionally substituted with 1, 2, or 3, Rb, R3 is selected from the group consisting of H, halogen, C13 alkyl, and C1-3 alkoxy…,” but claim 1 does not clearly state that one of the conditional phrases must occur. Further, claim 1 does not specify what R2, R3, and R4 would be in the instance that neither (1) R2 and R3 form a 3- to 6-membered heterocycle or (2) R2 and R4 form a 3- to 6-membered heterocycle. Accordingly, claim 1 is unclear.
Similarly, claim 2 recites two conditional phrases but does not require that one of the conditions must occur. Additionally, claim 2 does not specify what R2, R3, and R4 would be in the instance that neither (1) R2 and R3 form a 3- to 6-membered heterocycle or (2) R2 and R4 form a 3- to 6-membered heterocycle. Accordingly, claim 2 is unclear.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
3. Claim(s) 1-2, 4-6, 8, and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Li (WO 2022/143845, filed 30 Dec 2021, see IDS filed 8 Aug 2025, citations to English language equivalent: US PG-PUB 2025/0250267).
The reference, Li, is intervening art. 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.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Accordingly, priority has not been perfected and claims 1-2, 4-6, 8, and 10-15 are denied the benefit of the 16 April 2021 effective filing date. Instead, claims 1-2, 4-6, 8, and 10-15 have the benefit of the 15 April 2022 effective filing date.
Further, currently, the elected species,
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, does not seem to have support in the priority document, CN 2021/10412189.5, but does have support in the PCT/CN2022/087226 priority document. Accordingly, any claim directed to the elected species will only have be granted benefit of the 15 April 2022 (PCT) effective filing date.
Li teaches the compounds:
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,
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,
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,
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, and
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(Table A, pages 14 and 15). Further, Li teaches pharmaceutically acceptable salts of the compounds therein ([0013]; [0086]; [0091]; [0327]).
Regarding claim 1, while Li is silent to the elected species:
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, a person of ordinary skill in the art would contemplate making
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as it is the homolog of
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, which is taught by Li (Table A, page 14). Further, structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Deuel, 51 F.3d 1552, 1558, 34 USPQ2d 1210, 1214 (Fed. Cir. 1995). Additionally, structural similarities have been found to support a prima facie case of obviousness. See, e.g., In re May, 574 F.2d 1082, 1093- 95, 197 USPQ 601, 610-11 (CCPA 1978) (stereoisomers); In re Wilder, 563 F.2d 457, 460, 195 USPQ 426, 429 (CCPA 1977) (adjacent homologs and structural isomers); In re Hoch, 428 F.2d 1341, 1344, 166 USPQ 406, 409 (CCPA 1970) (acid and ethyl ester); In re Druey, 319 F.2d 237, 240, 138 USPQ 39, 41 (CCPA 1963) (omission of methyl group from pyrazole ring). Generally, some teaching of a structural similarity will be necessary to suggest selection of the claimed species or subgenus. The closer the physical and/or chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. See, e.g., Dillon, 919 F.2d at 696, 16 USPQ2d at 1904 (and cases cited therein). See MPEP § 2144.08(II)(A)(4)(c). As the compound of Li differs from the elected species of the claimed invention via one methylene unit (ethyl to methyl), a person of ordinary skill in the art would expect the compounds to have similar properties and thus would contemplate making them to try and obtain compounds with improved properties. Thus, Li teaches the compound,
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.
Regarding claim 2, Li teaches the compound,
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, and salts thereof (Table A, page 14; [0086]; [0327]). As the compound of Li differs from the elected species of the claimed invention via one methylene unit (ethyl to methyl), a person of ordinary skill in the art would expect the compounds to have similar properties and thus would contemplate making them to try and obtain compounds with improved properties. Accordingly, Li teaches a salt of the compound,
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.
Regarding claim 4, Li teaches the compound,
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, wherein R1 is OMe (Table A, page 14).
Regarding claim 5, Li teaches the compound,
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, wherein R5 is OEt (Table A, page 14). As the compound of Li differs from the elected species of the claimed invention via one methylene unit (ethyl to methyl), a person of ordinary skill in the art would expect the compounds to have similar properties and thus would contemplate making them to try and obtain compounds with improved properties. Accordingly, Li teaches R5 is OMe.
Regarding claim 6, Li teaches the compound,
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, wherein R2 and R3, together with the atom linked thereto, form aza-cyclopentyl (also known as pyrrolidine; Table A, page 14).
Regarding claim 8, Li teaches the compound,
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, wherein the structural unit is
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(Table A, page 14).
Regarding claim 10, Li teaches the compound,
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, wherein the structural unit is
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(Table A, page 14).
Regarding claim 11, Li teaches the compounds,
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,
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,
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, and
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(Table A, pages 14 and 15).
Regarding claim 12, Li teaches the compound,
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(Table A, page 14). As the compound of Li differs from the elected species of the claimed invention via one methylene unit (ethyl to methyl), a person of ordinary skill in the art would expect the compounds to have similar properties and thus would contemplate making them to try and obtain compounds with improved properties. Accordingly, Li teaches the compound,
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.
Regarding claim 13, Li teaches the compound,
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, and salts thereof (Table A, page 14; [0086]; [0327]). As the compound of Li differs from the elected species of the claimed invention via one methylene unit (ethyl to methyl), a person of ordinary skill in the art would expect the compounds to have similar properties and thus would contemplate making them to try and obtain compounds with improved properties. Accordingly, Li teaches a salt of the compound,
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.
Regarding claim 14, Li teaches the compounds,
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, and
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, and salts thereof (Table A, pages 14 and 15). As the compound of Li differs from the elected species of the claimed invention via one methylene unit (ethyl to methyl), a person of ordinary skill in the art would expect the compounds to have similar properties and thus would contemplate making them to try and obtain compounds with improved properties. Accordingly, Li teaches the compounds:
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.
Regarding claim 15, Li teaches the compounds,
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, and
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, and salts thereof (Table A, pages 14 and 15; [0086]; [0327]). As the compound of Li differs from the elected species of the claimed invention via one methylene unit (ethyl to methyl), a person of ordinary skill in the art would expect the compounds to have similar properties and thus would contemplate making them to try and obtain compounds with improved properties. Accordingly, Li teaches a salt of the compounds:
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
4. Claim 1-2, 4-6, 8, and 10-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12-13 of copending Application No. 19/106,366 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
U.S. Application No. 19/106,366 claims a compound of Formula (I):
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, and specifically claims the compounds,
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,
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, ,
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,
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, and
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(claims 1 and 12-13 of ‘366).
Regarding claim 1, ‘366 teaches the compound,
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(claim 13 of ‘366). While ‘366 is silent to the genus of claim 1, a person of ordinary skill in the art would contemplate making the homolog of
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, in which R5 is ethyl (instead of ethenylene as taught by claim 13 of ‘366). Further, structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Deuel, 51 F.3d 1552, 1558, 34 USPQ2d 1210, 1214 (Fed. Cir. 1995). Additionally, structural similarities have been found to support a prima facie case of obviousness. See, e.g., In re May, 574 F.2d 1082, 1093- 95, 197 USPQ 601, 610-11 (CCPA 1978) (stereoisomers); In re Wilder, 563 F.2d 457, 460, 195 USPQ 426, 429 (CCPA 1977) (adjacent homologs and structural isomers); In re Hoch, 428 F.2d 1341, 1344, 166 USPQ 406, 409 (CCPA 1970) (acid and ethyl ester); In re Druey, 319 F.2d 237, 240, 138 USPQ 39, 41 (CCPA 1963) (omission of methyl group from pyrazole ring). Generally, some teaching of a structural similarity will be necessary to suggest selection of the claimed species or subgenus. The closer the physical and/or chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. See, e.g., Dillon, 919 F.2d at 696, 16 USPQ2d at 1904 (and cases cited therein). See MPEP § 2144.08(II)(A)(4)(c). As the compound of ‘366 differs from the claimed invention via saturation (ethenylene to ethylene), a person of ordinary skill in the art would expect the compounds to have similar properties and thus would contemplate making them to try and obtain compounds with improved properties. Thus, ‘366 teaches a compound of claim 1.
Regarding claim 2, ‘366 teaches the compound,
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, and salts thereof (claim 13 of ‘366). As the compound of ‘366 differs from the elected species of the claimed invention via saturation (ethenylene to ethylene), a person of ordinary skill in the art would expect the compounds to have similar properties and thus would contemplate making them to try and obtain compounds with improved properties. Accordingly, ‘366 teaches a salt of a compound of claim 1.
Regarding claim 4, ‘366 teaches the compound,
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, wherein R1 is OMe (claim 13 of ‘366).
Regarding claim 5, ‘366 teaches the compound,
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, wherein R5 is ethyl (claim 13 of ‘366). As the compound of ‘366 differs from the elected species of the claimed invention via saturation (ethenylene to ethylene), a person of ordinary skill in the art would expect the compounds to have similar properties and thus would contemplate making them to try and obtain compounds with improved properties. Accordingly, ‘366 teaches R5 is ethyl.
Regarding claim 6, ‘366 teaches the compound,
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, wherein R2 and R3, together with the atom linked thereto, form aza-cyclopentyl (also known as pyrrolidine; claim 13 of ‘366).
Regarding claim 8, ‘366 teaches the compound,
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, wherein the structural unit is
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(claim 13 of ‘366).
Regarding claim 10, ‘366 teaches the compound,
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, wherein the structural unit is
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(claim 13 of ‘366).
Regarding claim 11, ‘366 teaches the compounds,
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,
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, and
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(claims 13 of ‘366).
Regarding claim 12, ‘366 teaches the compound,
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(claim 13 of ‘366). As the compound of ‘366 differs from the elected species of the claimed invention via saturation (ethenylene to ethylene), a person of ordinary skill in the art would expect the compounds to have similar properties and thus would contemplate making them to try and obtain compounds with improved properties. Accordingly, ‘366 teaches a compound of claim 1.
Regarding claim 13, ‘366 teaches the compound,
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. and salts thereof (claim 13 of ‘366). As the compound of ‘366 differs from the elected species of the claimed invention via saturation (ethenylene to ethylene), a person of ordinary skill in the art would expect the compounds to have similar properties and thus would contemplate making them to try and obtain compounds with improved properties. Accordingly, ‘366 teaches a salt of a compound of claim 1.
Regarding claim 14, ‘366 teaches the compounds,
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, and
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(claims 13 of ‘366). As the compound of ‘366 differs from the elected species of the claimed invention via saturation (ethenylene to ethylene), a person of ordinary skill in the art would expect the compounds to have similar properties and thus would contemplate making them to try and obtain compounds with improved properties. Accordingly, ‘366 teaches the compounds:
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, and
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(claims 13 of ‘366).
Regarding claim 15, ‘366 teaches the compounds,
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,
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,
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, and
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, and salts thereof (claims 13 of ‘366). As the compound of ‘366 differs from the elected species of the claimed invention via saturation (ethenylene to ethylene), a person of ordinary skill in the art would expect the compounds to have similar properties and thus would contemplate making them to try and obtain compounds with improved properties. Accordingly, ‘366 teaches a salt of the compounds:
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,
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,
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, and
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(claims 13 of ‘366).
Relevant Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The reference, Mainolfi (J. Med. Chem., 2020, 63, 5697-5722, see IDS filed 10 Jan 2024) is the closest prior art that predates the priority document, CN 2021/10412189.5, which has the effective filing date of 16 April 2021.
Mainolfi teaches the structure activity relationships leading to the Factor B inhibitor, LNP023,
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(abstract). Further, Mainolfi teaches Compound 38, wherein R is methyl and Z is methoxy:
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, which shares a core with the elected species of the claimed invention (Table 5, page 5704).
While Mainolfi teaches most of the elected species,
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, Mainolfi does not teach a bridged piperidine core and thus does not teach a bridged pyrrolidine and piperidine nor motivations to make the bridged system (Figure 4, page 5702). Thus, Mainolfi does not teach the elected species (nor its genus).
Conclusion
No claim is allowed.
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/MADELINE M. DEKARSKE/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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