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 .
Election/Restrictions
Applicant’s election with traverse of Group I (claims 1 – 11, and 14 – 18) drawn to a novel bicyclic compounds of formula (I)
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where n, Ring A, Ring B, Ring C, and R1-7 are defined and the species election of 4,7-dime thyl-3-(1-propionyl-5-(p- tolyl)-4,5-dihydro-1H-pyrazol-3-yl)-1 ,8-naph thyridin-2(1H)-one of structure
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in the reply filed on July 10th, 2026 is acknowledged.
Claims 12 – 13, and 19 – 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II (a method of inhibiting RAD51 protein), there being no allowable generic or linking claim. Moreover, claims 3 – 4, 6 – 7, 9, 14, and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected chemical species (chemical species of Formula (Ia), Formula (Id), and select species), there being no allowable generic or linking claim. Election was made with traverse in the reply filed on July 10th, 2026.
Hence claims 1 – 2, 5, 8, 10 – 11, 15, and 17 – 18 are being examined on the merits herein.
However, the initial search of the elected species of structure
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was found to be free of the prior art; therefore, the search was expanded to include the chemical specie of structures
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and
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. Hence claims 4 and 14, which recite chemical species that are encompassed by the expanded structure have been rejoined. However, the election of species required in the Restriction Requirement mailed June 9th, 2026 is still maintained against all other chemical species, and the restriction between Groups I and Group II is also maintained.
Hence claims 1 – 2, 4 – 5, 8, 10 – 11, 14 – 15, and 17 – 18 are being examined on the merits herein.
Response to Arguments
Applicant's arguments filed July 10th, 2026 have been fully considered but they are not persuasive.
Applicant argues that the examiner’s assertion for lack unity is incorrect because both Group I (product-a novel bicyclic compound of formula (I)) and Group II (use-method of inhibiting RAD51 protein comprising administering a therapeutically effective amount of a compound according to Group I) share a technical relationship involving the same special technical feature. See applicant’s remarks page 4 paragraph 4. Moreover, applicant argues that the method claimed in Group II is entirely dependent on the specific chemical structure and functional utility of the product of Group I thus sharing a single technical feature. See applicant’s remarks page 5 paragraph 1. Furthermore, applicant argues that the substituted two-ring (bicyclic) structure are absolutely necessary for the inhibiting RAD51 protein and form a common technical link between al the different compound in the present application. See applicant’s remarks page 5 paragraph 1.
While the examiner agrees that there is a technical feature linking Group I and Group II and the chemical species the feature is not a special or innovative technical feature of the prior art. As set forth in Rule 13.1 of the Patent Cooperation Treaty (PCT), "the international application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept ("requirement of unity of invention").” Moreover, as stated in PCT Rule 13.2, "where a group of inventions is claimed in one and the same international application, the requirement of unity of invention referred to in Rule 13.1 shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features." Furthermore, Rule 13.2 defines "special technical features" as "those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art." See MPEP 1850(I) and 1850(II).Thus the technical feature of a substituted two-ring (bicyclic) RAD51 protein inhibitors is not a special technical feature especially in view of prior art reference International Publication Number WO 2021/116999 A1 to Cavalli et.al. (Cavalli’999; cited on the ISR form).
Thus the group and species election requirement set forth in the office action mailed June 9th, 2026 is maintained, deemed proper, and is made final.
Claim Objections
Claim 8 is objected to because of the following informalities: contains period within the body of the claim. In particular claim 8 recites chemical names with the numbering ending in a period. Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). See MPEP 608.01(m). 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.
Claims 10 and 17 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 10 recites the limitation "the pharmaceutical composition" in line 1. Claim 10 depends from independent claim 1; however, claim 1 does not recite a pharmaceutical composition. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the pharmaceutical composition" in line 1. Claim 17 depends from independent claim 8; however, claim 8 does not recite a pharmaceutical composition. There is insufficient antecedent basis for this limitation in the claim.
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, 5, 10 – 11, and 14 – 15 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by International Publication Number WO 2021/116999 A1 to Cavalli et.al. (Cavalli’999; cited on the ISR form).
Regarding claims 1 – 2, 4, 5, 10 – 11, and 14 – 15, Cavalli’999 teach novel compounds acting as RAD51-BRCA2 interaction disrupters. See page 4. Cavalli’999 teach compounds of formula (Ia):
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where reference ring A and reference ring B individually and independently selected from the group consisting of aryl, heteroaryl, cycloalkyl and heterocycloalkyl that are unsubstituted or substituted. See page 13. In particular, Cavalli’999 teach species compound example compound d. 12 of structure
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and example d. 63. of structure
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. See page 82 and 185. See claim 1 limitation for a bicyclic compound of formula (I) where ring A = phenyl where R1 = H and R2 = Cl; ring B = pyrazoline where R4 = C(O)-R4a further where R4a = CH3 or CH2CH3; Ring C = phenyl where R5 = H and R6 = CF3 or OCH3; R3 = CH3-C6H5 or C6H5; R7 = H; and n = 0. See claim 2 limitation for a bicyclic compound of formula (I) where ring A along with the attached ring is
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. See claim 4 limitation for a bicyclic compound of formula (I) according to claim 1, where the compound is formula (Ib)
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where R1 = H and R2 = Cl; R4 = C(O)-R4a further where R4a = CH3 or CH2CH3; Ring C = phenyl where R5 = H and R6 = CF3 or OCH3; R3 = CH3-C6H5 or C6H5; R7 = H; and n = 0. See claim 5 limitation for a bicyclic compound of formula (I) according to claim 1, where the compound is formula (Ic)
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where A = B= C = D = CR’ with double bonds between A – B and C – D where R’ on A, C, and D = H and R’ on B = Cl; R4 = C(O)-R4a further where R4a = CH3 or CH2CH3; Ring C = phenyl where R5 = H and R6 = CF3 or OCH3; R3 = CH3-C6H5 or C6H5; R7 = H; and n = 0. See claim 14 limitation for a bicyclic compound of formula (I) according to claim 4, where ring C is specifically represented by
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. See claim 15 limitation for a bicyclic compound of formula (I) according to claim 5, where ring C is specifically represented by
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.
Moreover, Cavalli’999 teach that the compounds of the disclosure which includes compound examples d. 12 and d. 63 where assayed in doses from 0.01 to 100 mM in PBS buffer containing 0.05% Tween-20 and 1 % DMSO. See page 266 – 267. See claim 10 limitation for a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable carrier or excipient.
Regarding claim 11, limitation for a compound according to claim 1, for use as a medicament. Even though preamble of claim 11 recites a compound for use as a medicament; the preamble does not provide any structural limitation to the composition as recited in claim 11. Thus the preamble, for use as a medicament, is a statement of purpose or use. Therefore, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See MPEP 2111.02(II). Thus the assay sample of Cavalli’999 which comprises compound examples d. 12 and d. 63 in PBS buffer containing 0.05% Tween-20 and 1 % DMSO anticipates the medicament of claim 11.
Claim Rejections - 35 USC § 103
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.
Claims 8, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 2021/116999 A1 to Cavalli et.al. (Cavalli’999; cited on the ISR form).
Regarding claims 8, 17, and 18, Cavalli’999 teach novel compounds acting as RAD51-BRCA2 interaction disrupters. See page 4. Cavalli’999 teach compounds of formula (Ia):
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where reference ring A and reference ring B individually and independently selected from the group consisting of aryl, heteroaryl, cycloalkyl and heterocycloalkyl that are unsubstituted or substituted. See page 13. In particular, Cavalli’999 teach species compound example compound d. 12 of structure
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. See page 82. Moreover, Cavalli’999 teach that the compounds of the disclosure which includes compound examples d. 12 where assayed in doses from 0.01 to 100 mM in PBS buffer containing 0.05% Tween-20 and 1 % DMSO. See page 266 – 267.
However, Cavalli’999 does not explicitly teach the compound 6-chloro-4-cyclopropyl-3-(5-(4-methoxyphenyl)-1-propionyl-4,5-dihydro-1H-pyrazol-3-yl)quinolin-2(1H)-one of structure
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. See claim 8 limitation. Moreover, Cavalli’999 does not explicitly teach the compound 6-chloro-4-cyclopropyl-3-(5-(4-methoxyphenyl)-1-propionyl-4,5-dihydro-1H-pyrazol-3-yl)quinolin-2(1H)-one of structure
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in a pharmaceutical composition. See claims 17 – 18 limitation.
Nevertheless, Cavalli’999 does teach compounds with identical bicyclic scaffold as RAD51 inhibitors. Moreover, Cavalli’999 does teach that reference ring A, which is equivalent the examine ring A, can be a cycloalkyl. Given that the only difference between the prior art compound of structure
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taught by a Cavalli’999 and examined compound
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of claim 8 is reference ring A, that is a phenyl ring versus a cyclopropyl ring. And given that the prior art of Cavalli’999 does teach that reference ring A can be a cycloalkyl and that these compounds are RAD51 inhibitors it would have been within the purview of one of ordinary skill in the art to synthesize 6-chloro-4-cyclopropyl-3-(5-(4-methoxyphenyl)-1-propionyl-4,5-dihydro-1H-pyrazol-3-yl)quinolin-2(1H)-one in optimizing for RAD51 inhibitors.
Regarding claim 18, limitation for a compound according to claim 8, for use as a medicament. Even though preamble of claim 18 recites a compound for use as a medicament; the preamble does not provide any structural limitation to the composition as recited in claim 18. Thus the preamble, for use as a medicament, is a statement of purpose or use. Therefore, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See MPEP 2111.02(II). Thus the assay sample of Cavalli’999 which comprises compound examples d. 12 in PBS buffer containing 0.05% Tween-20 and 1 % DMSO is renders obvious the medicament of claim 18.
Therefore, it would have been obvious before the effective filing date of the instant application to modify compound d.12 of Cavalli’999 to substitute the phenyl ring for a cyclopropyl ring and to assay that compound to see the RAD51 activity. One of ordinary skill in the art would have been motivated to try in order to improve the activity against RAD51. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because the prior art taught that the bicyclic ring structure can accommodate cycloalkyls in that opposition.
Conclusion
Claims 1 – 2, 4 – 5, 8, 10 – 11, 14 – 15, and 17 – 18 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
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