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
Instant application 17/762,257 filed on 03/21/2022 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 1-15, 17-18, 20, 22-24, 26-28, 31-34 and 39-46 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/22/2025 and 09/13/2022 was in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election, without traverse, of Group I in the reply filed on 08/22/2025 is acknowledged.
Claims 33, 34 and 39-46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 08/22/2025.
Regarding species election, Applicant’s election, without traverse, of
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in the reply filed on 08/22/2025 is acknowledged.
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Claim 8, 12-15, 22-24, 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/22/2025.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. 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 reexamined. 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 reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does make a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable; the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
Species Election
A careful review of the prior art has indicated that elected species is free of the prior art. A claim directed to the elected species in independent form would be free of the prior art.
The examiner has moved onto alternative species:
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The subsequent examination is based on this species expansion.
The whole scope of claim 1 has not been searched.
Claim Objections
Claim 27 is objected to because of the following informalities:
Claim 27 recites:
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[…]
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In order to make claim 27 clearer “R1, R1’, R2, and n are as described herein” should be replaced with “R1, R1’, R2, and n are as described in claim 1”.
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.
Claim 3 is 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 compound of claim 1, wherein the compound of Formula I’ is not, for example, 1-Benzyl-3-[2-(4-ethyl- piperazin-1-yl)-4-methyl-quinolin-6-yl]-1-methyl-thiourea.
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There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recite:
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It should be noted that phenyl is not listed as R1, thus, 1-benzyl-3-[2-(4-ethyl- piperazin-1-yl)-4-methyl-quinolin-6-yl]-1-methyl-thiourea does not fall under the instant Formula I’ recited in claim 1.
Applicant is requested to check all compounds recited in claim 3 to make sure the compounds fall under Formula I’.
In addition, it is not clear why the compounds recited in claim 3 are not excluded from claim 1. Explanation is requested.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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, 2, 4, 6, 9-11, 20, 27, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnston (WO-2016090371-A2).
This rejection applies to expanded species.
Johnston teaches methods of treating and/or reducing the incidence of cancer (paragraph 83).
Johnston teaches compound 103 (page 58)
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that falls under the definitions of instant Formula I’:
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(instant claim 1) wherein X is N, Y is CH2, n is 0, R3 is C1 alkyl (methyl), Z is
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R1 is H and R1’ is C3 alkyl (isopropyl).
Regarding instant claim 31, Johnston teaches pharmaceutical compositions comprising a pharmaceutically acceptable diluent or carrier.
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It should be noted that the above compound has been exclude from claim 3, however, the compound has not been excused from 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 1-7, 9-11, 17-18, 20, 27-28 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Mazin (WO2016196955).
This rejection applies to expanded species.
Mazin teaches RAD52 inhibitors for treating cancers (abstract).
Mazin teaches compounds of formula (I):
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Regarding claims 31 and 32, Mazin teaches pharmaceutical composition comprising pharmaceutically acceptable carrier (page 2, lines 17-19):
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Further, Mazin discloses compound D-103:
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Compound D-103 disclosed by Mazin does not fall under instant Formula I’ because instant claim 1 recite a proviso “provided that R2 and R3 are not simultaneously CH3”.
However, compound D-103 differs from instant compound 0048 only in one position (R2).
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Compound D-103 bears methyl group whereas instant compound 0048 bears hydrogen in a corresponding position (R2 variable).
Mazin discloses formula I wherein:
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Further, Mazin teaches heterocycloalkyl groups are (see page 16):
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Therefore, the instant compounds fall under the broad definition of formula (I) of Mazin.
Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute methyl for hydrogen with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to synthesize further examples that falls under the definitions of Mazin’s formula (I). Since Mazin teaches RAD52 inhibitors of formula (I) for treating cancers, a skilled artisan would have been motivated to prepare further examples of RAD52 inhibitors for the same purpose.
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 1-7,9-11,17-18,20,27-28 and 31-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. US-10442817-B2.
This rejection applies to expanded species
The claims of US-10442817-B2 recite a methods of treating cancer comprising administering effective amount of compound of formula (I):
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The claims of US-10442817-B2 recite 1-(2-diethylamino)ethyl)-3-(4-methyl-2-(4-methylpiperazin-1-yl)quinolin-6-yl)thiourea (see claim 3, line 66).
1-(2-diethylamino)ethyl)-3-(4-methyl-2-(4-methylpiperazin-1-yl)quinolin-6-yl)thiourea (compound D-103)
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differs from instant compound 0048 only in one position (R2).
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Compound D-103 bears methyl group whereas instant compound 0048 bears hydrogen in a corresponding position (R2 variable).
Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute methyl for hydrogen with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to synthesize further examples of RAD52 inhibitors that falls under formula (I) recited by US-10442817-B2. Since the claims of US-10442817-B2 recite RAD52 inhibitors of formula (I) for treating cancers, a skilled artisan would have been motivated to prepare further examples of RAD52 inhibitors for the same purpose.
Claims 1-7,9-11,17-18,20,27-28 and 31-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9 of U.S. Patent No. US-10738061-B2.
This rejection applies to expanded species.
Claims of US-10738061-B2 recite:
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Further, the claim 1 of US-10738061-B2 recite R2 is NR4R5 wherein R4 and R5 may be connected to form a 3-10 membered heterocycloalkyl; wherein if the 3-10 membered heterocycloalkyl in R2 is a six membered ring, then R2 is a six - membered unsubstituted heterocycloalkyl or
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.
The claims of US-10738061 fail to recite an embodiment that anticipates the instant claims.
However, the claims of US-10738061 recite structurally similar compounds. The instant compounds fall under the general formula (I) recited in US-10738061, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare further compounds falling under the general formula (I) with a reasonable expectation of success. Since the claims of US-10738061-B2 recite RAD52 inhibitors of formula (I) for treating cancers, a skilled artisan would have been motivated to prepare further examples of RAD52 inhibitors for the same purpose.
Claims 1-7, 9-11, 17-18 ,20, 27-28 and 31-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/265,428.
Claims of copending Application No. 19/265,428 recite:
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Claims of copending Application No. 19/265,428 recite:
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For example, the claims of copending Application No. 19/265,428 recite (see claim 4):
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The compound recited in claims of Application No. 19/265,428 bear isoquinoline moiety whereas the instant compound bear quinoline at the corresponding position. Therefore, the instant compounds of Formula I’ are positional isomers of compounds recited in claims of Application No. 19/265,428.
MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.)”.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.S./Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621