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 .
DETAILED ACTION
Election/Restriction
Applicant elected Group I (claims 1-6, 8, 10, 12-15, 17-19, 21, 22 and 24- 25), drawn to a compound of Formula I, and Example 1, 4-chloro-3-(5, 7-difluoro-4- oxo-1,4-dihydroquinolin-2-yl)benzonitrile (See specification at [00113]) having following structure as a species representative of Formula I, in the reply filed on 02/10/2026.
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Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claim 26 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Example I is a compound of Formula I,
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R1 is hydrogen; R2 is halo (chloro); R3 is cyano; R4 is hydrogen; R5 is halo (fluoro); R6 is halo (fluoro); q is 0; and r is 1.
Claims 1-6, 8, 10, 13, 15, and 24-25 read on the elected invention and species.
Claims 12, 14, 17-19 and 21-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
The elected species, Example 1 (CAS# 2829349-96-2, entered STN database on 09/25/2022 ) is found free of anticipatory 102 prior art.
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The examiner has expanded the search to non-elected species, wherein R1 is hydrogen, R2 is halo, R3 is CN or NO2, R4 is hydrogen, R5 is halo, R6 is halo. These non-elected species are rejected under following 103 rejection. Other non-elected species are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species. The absence of other citations of prior art should not be interpreted as an indication that other subgenera within Formula I are free of prior art. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reconsidered. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reconsideration that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
Status of Claims
Claims 1-6, 8, 10, 12-15, 17-19, 21, 22 and 24- 26 are pending in the instant application.
Claims 12, 14, 17-19, 21-22 and 26 are withdrawn.
Claims 1-6, 8, 10, 13, 15, and 24-25 are currently under examination.
Priority
This instant application 18/279,292 filed 08/29/2023, is a 371 of PCT/US2022/018283 filed on 03/01/2022, which claims benefit of US provisional application 63/155,410, filed March 2, 2021.
It’s noted US provisional application 63/155,410 only disclosed compound species Example 1-12, including the elected species, Example 1. The effective filing date for instant compound species 13-119 that are NOT disclosed in US provisional application 63/155,410 are considered to be 03/01/2022, the effective filing date of PCT/US2022/018283. The search of prior art is extended before 03/02/2021.
Information Disclosure Statement
The information disclosure statement dated 10/20/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the reference listed in IDS are being considered by the Examiner.
Abstract
The abstract of the disclosure is objected to because the abstract is less than 50 words and does not describe the disease /conditions associated with PPARG. PPARG should be rewritten in full names.
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
Applicant is reminded of the proper content of an abstract of the disclosure. A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
Claims 2 and 24 are objected to because of the following informalities.
Claim 2 and 24 recite the compound is of the Formula II or of the structural formulation, wherein “of the” are not necessary.
Claim 24 recites “or a pharmaceutically acceptable salt of any of the foregoing”. For consistency, claim 24 can be clarified by reciting a pharmaceutically acceptable salt thereof.
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.
Claims 1-6, 8, 10, 13, 15 and 25 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.
Instant claim 1 recites compound of Formula I wherein R5, R6 and R7 are substituents attached to the same ring without defined positions. The definition of R5, R6 and R7 are different, but overlaps, including halogen, halo(C1-C4)alkyl groups. It’s unclear how to define a halogen on the quinolinone ring as R5, R6 or R7. For example, di-fluoro on the quinolinone ring could be considered as R5, R6(r=1)/ R7(q=0) or R6(r=0)/ R7(q=1). The lack of clarity renders compound of Formula I and claim 1 indefinite since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
Claims 2-6, 8, 10, 13, 15 and 25 are rejected due to dependency on claim 1.
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.
Claims 1-6, 8, 10, 13, 15 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (WO2022010150A1 published on 01/13/2022 in Korea, Applicant’s IDS dated 10/20/2023, the teachings of WO2022010150A1 is illustrated by family member US20230271925A1, hereafter “Park ’925”).
Park’925 discloses 4(1H)-quinolinone compound of formula I, II, IIa, etc. as inhibitor of tumor necrosis factor (TNF), pharmaceutical compositions comprising aforementioned 4(1H)-quinolinone compounds, and methods of treating TNF associated diseases/conditions (e.g. cancer, etc.) (See abstract, [0002], [0012], [0126]- [0145], [0242]-[0243], Examples 1-45, claims 1-12 and 16-17).
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R2 is halogen, CN, NO2, C1-C6 alkyl, etc. by Park’925 read on instant R2, R3 and/or R4. R1 is halogen, CN, C1-C6 alkyl, etc. by Park’925 read on instant R5, R6 and/or R7.
Park’925 teaches compound species that are similar to instant claimed compounds (See [0270], Examples 1-30).
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It’s noted compound 1-14 by Park’925 read on instant R2 is halo, R5 is halo, q is 0 and r is 0. and similar to instant non-elected species recited in claim 24
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According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
Park’925 teaches the core structure of 4-quinolinone and compound species comprising halogen substituent on the ring. It would have been prima facie obvious to one of ordinary skilled in the art before the effective filing date of instant application to further explore more substituents based on the collective teachings of Park’925 and general knowledge of structure similarity and bioisosteric modification for SAR study of TNF inhibitor. One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and general knowledge of structure similarity and bioisosteric modification of SAR study. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-6, 8, 10, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Chein et al. (US 2020/0330449 A1).
Chein et al. teaches 4(1H)-quinolone compound of formula I as microtubule-targeting agents , pharmaceutical compositions comprising aforementioned 4(1H)-quinolone compounds, and methods of treating, delaying, and/or preventing the adverse effects of proliferative diseases associated with P-glycoprotein (P-gp) overexpression, e.g. cancers (See abstract, [0007]-[0008], [0018] [0025], Table 3, Examples, claims 1-44).
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It’s noted the R1 is halogen, CN, substituted alkyl, etc. by Chein read on instant R2, R3 and/or R4. R2 is halogen, optionally substituted alkyl, aryl, heterocyclyl, heteroaryl, etc.by Chein read on instant R5, R6 and/or R7.
Chein teaches compounds species that are similar to instantly claimed compounds(See [0025], Table 3, [0153])
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According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
Chein teaches the core structure of 4-quinolinone and compound species comprising halogen substituent on the ring. It would have been prima facie obvious to one of ordinary skilled in the art before the effective filing date of instant application to further explore more substituents based on the collective teachings of Chein and general knowledge of structure similarity and bioisosteric modification in searching for alternative microtubule-targeting to overcome cancer drug resistance. One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and general knowledge of structure similarity and bioisosteric modification of SAR study. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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.
Claims 1-6, 8, 10, 13, 15, and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11820747B2.
Reference claims are directed to a compound, or salt thereof for treating urothelial cancer.
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Reference compound is very similar to instant claimed compound of Formula I except R2.
According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
The instant application shares at least one common inventor /applicant with the reference patent. Furthermore, the instant application is not related to the reference patent based on the record, thus no 35 USC 121 shield exists.
Claims 1-6, 8, 10, 13, 15, and 24-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-16, 19, and 24-25 of copending application No. 18/294,768 in view of Patani (Chemical Reviews, 1996. Vol. 96, 8: 3147-3176).
Reference claims are directed to compound of Formula I, with similar definition of R1 to R7
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Reference claim 24 recite compound species that are very similar to instant compounds except X is N verse instant CH ( pyridine ring vs benzene ring) .
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CH and N are classic bioisosteres based on Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres, which is within general knowledge of SAR study to a skilled artisan as taught by Patani. Patani et al. teaches a group of bioisosteres elicit similar biological activity, and have been classified as either classical or nonclassical, wherein the classical bioisosteres are a series of replacements defined by Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres (See p. 3148-3149).
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According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
The instant application shares at least one common inventor /applicant with the reference patent. Furthermore, the instant application is not related to the reference patent based on the record, thus no 35 USC 121 shield exists.
Conclusion
NO claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
1. Compound CAS# 371250-91-8 from STN database
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached on (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.M./ Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
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