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 .
Status of the Claims
Currently, claims 1-30 are pending in the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/18/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. It is herein noted that the IDS appears to be missing the first page. The submitted IDS begins at page 2 of 7 with foreign patent document citations No. 005-008. These foreign patent documents have been considered by the Examiner, however any other submitted foreign patent documents which have not been listed in the IDS have not been considered.
Election/Restrictions
In response to the Restriction Requirement submitted on 09/04/2025, Applicant has elected the following invention:
Claims 1-14, 24, and 26-30 drawn to a compound of Formula (II) and methods of use of said compound in the treatment of CDK2 mediated diseases, classified in A61K 31/4439 and A61P 35/00
Accordingly, claims 1-14, 24 and 26-30 will be pending examination while, claims 15-23 and 25 will be withdrawn.
In response to the Election Requirement submitted on 09/04/2025, Applicant has elected the following compound 145a, as a species of Formula (II):
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The elected compound appears to be free of the art. Accordingly, the election requirement is hereby withdrawn, and claims 1-14, 24, and 26-30 will be pending examination.
Claim Objections
Claims 6 and 10-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112 – Second Paragraph
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 24 and 30 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 24 is indefinite for reciting “a compound of Table 1A” because a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim. The instant claim references Table 1A from Applicant’s specification, paragraph [0277]. However, the claims must positively recite the compounds being claimed. This rejection may be overcome by amending the claim such that it recites the compounds of Table 1A within the claim itself.
Claim 30 is indefinite for reciting “wherein the administering is selective for CDK2 over a CDK selected from CDK1, CDK4, and CDK6” because a person of ordinary skill in the art would not reasonable be able to understand the metes and bounds of the claim. The instant claim does not provide any tangible structure or actionable steps to its parent method, and a person of ordinary skill would not be able to understand what would be needed to alter the administration of the target compound/composition such that it would be selective for a particular CDK over another.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5 and 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li (WO 2023/274397 A1).
Claim 1 recites a compound of Formula (II):
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286
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Li teaches compounds as CDK2 inhibitors, and use of such compounds in the treatment of CDK mediated diseases. Among the compounds taught by He is the following compound (page 88):
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The compound taught by Li is a tautomer of a compound of Formula (II). It is generally understood in the art that tautomers are inherent to a compound and readily interconvert between forms. A structural representation of the tautomer of the compound is provided below:
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497
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The above compound anticipates a compound of Formula (II) wherein:
Ring A is a 9 membered heterocycle
L is L1, wherein
L1 is -N(R12)-, wherein R12 is H
R1 is H
R2 is C3 alkyl (i.e., isopropyl)
R3 is H
R17 is H
R18 is C1 alkyl
n is 0
m is 1
Claim 2 further limits the compound of claim 1 wherein R17 is H.
The compound of Li is a compound of Formula (II) wherein R17 is H.
Claim 3 further limits the compound of claim 1 wherein R18 is selected from H, C1-6 alkyl, and C1-6 haloalkyl.
The compound of Li is a compound of Formula (II) wherein R18 is C1 alkyl.
Claim 5 further limits the compound of claim 1 wherein
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is selected from:
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The compound of Li is a compound of Formula (II) wherein the corresponding moiety is
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45
59
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.
Claim 7 further limits the compound of claim 1 wherein one of R1 and R2 is selected from H, C1-6 alkyl, and C1-6 haloalkyl, and the other is selected from:
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The compound of Li is a compound of Formula (II) wherein R1 is H and R2 is C3 alkyl.
Claim 8 further limits the compound of claim 1 wherein one of R1 and R2 is selected from hydrogen, methyl, ethyl, and propyl, and the other is selected from methyl, ethyl, propyl,
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The compound of Li is a compound of Formula (II) wherein R1 is H and R2 is
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57
54
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.
Claim(s) 9 and 1 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by He (WO 2022/206888 A1).
Claim 9 further limits the compound of claim 1 wherein R1 and R2 come together to form a 3-10 membered heterocycle, optionally substituted with one or more substituents selected from halogen, -OR15, -N(R15)2, -NO2, =O, -CN, C1-6 alkyl, and C1-6 haloalkyl.
He teaches compounds as CDK2 inhibitors and use of such compounds for the treatment of CDK2 related diseases. Among the compounds taught by He is the following (page 315):
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The above compound anticipates a compound of Formula (II) wherein:
Ring A is a 6 membered heterocycle
L is L1, wherein
L1 is -N(R12)-, wherein R12 is H
R1 and R2 come together to form a 5 membered heterocycle
R3 is H
R17 is H
R18 is -OR11, wherein:
R11 is C2 alkyl substituted with NH2
n is 0
m is 1
Claim(s) 13-14 and 26-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li.
Claim 13 further limits the compound of claim 1 wherein R3 is hydrogen.
The compound of Li is a compound of Formula (II) wherein R3 is hydrogen.
Claim 14 further limits the compound of claim 1 wherein R4 is independently selected from halogen, -OR11, -N(R11)2, -NO2, -CN, C1-6 alkyl, and C1-6 haloalkyl.
As the presence of variable R4 is dependent upon, the variable n, the compound of Li anticipates the instant claim wherein the compound has an n value of 0.
Claim 26 recites a pharmaceutical composition comprising a compound or salt of claim 1, and a pharmaceutically acceptable excipient.
As previously discussed, Li teaches a compound of claim 1. Li further teaches pharmaceutical compositions comprising said compounds for treatment of CDK mediated diseases (Li Description translation page 20)1.
Claim 27 recites a method of treating a disease or disorder mediated by CDK2 comprising, administering to a subject in need thereof the compound or salt of claim 1, or a pharmaceutical composition comprising a compound or salt of claim 1 and a pharmaceutically acceptable excipient.
As iterated previously, Li anticipates a compound of Formula (II) of claim 1. The teachings of He further indicate that such compounds may be used as CDK2 inhibitors for the use of treating CDK mediated cancers (Abstract)2.
Claim 28 further limits the method of claim 27 wherein the disease is cancer.
As discussed previously, Li indicates cancer as a CDK mediated disease to be treated by administering their compounds.
Claim 29 further limits the method of claim 28 wherein the cancer is selected from breast cancer, ovarian cancer, bladder cancer, uterine cancer, prostate cancer, lung cancer, esophageal cancer, head and neck cancer, colorectal cancer, kidney cancer, liver cancer, pancreatic cancer, stomach cancer, and thyroid cancer.
As discussed previously, Li indicates the treatment of CDK mediated cancer. Li further indicates that such cancers include breast cancer, ovarian cancer, prostate cancer, melanoma, brain tumor, esophageal cancer, gastric cancer, liver cancer, pancreatic cancer, colorectal cancer, lung cancer, kidney cancer, skin cancer, glioblastoma, neuroblastoma Cell tumors and sarcomas (Li Description translation page 20)3.
Allowable Subject Matter
Claims 6 and 10-12 appear to contain allowable subject matter, however are not allowable due to being dependent upon a rejected base claim, and accordingly, are objected to (see claim objections).
Conclusion
Claims 1-5, 7-9, 13-14, 24, and 26-30 are rejected.
Claims 6 and 10-12 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC TRAN whose telephone number is (571)272-7854. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 “In certain embodiments, the pharmaceutical composition contains 0.01%-99.99% of pharmaceutically acceptable excipients based on the total weight of the composition. In certain embodiments, the pharmaceutical composition contains 0.1%-99.9% of pharmaceutically acceptable excipients. In certain embodiments, the pharmaceutical composition contains 0.5%-99.5% of pharmaceutically acceptable excipients. In certain embodiments, the pharmaceutical composition contains 1%-99% of pharmaceutically acceptable excipients. In certain embodiments, the pharmaceutical composition contains 2%-98% of pharmaceutically acceptable excipients.”
2 “Disclosed are a cyclin-dependent kinase 2 (CDK2) inhibitor as shown in formula I, a preparation method therefor and use thereof. The compound of formula I can be used as a CDK inhibitor for preventing and/or treating diseases associated with CDK or cyclin such as cell proliferative diseases, cancer, or immune diseases.”
3 “The present disclosure also provides a method for preventing and/or treating a patient suffering from cancer, by administering to the patient a therapeutically effective amount of the compound described in the present disclosure or a pharmaceutically acceptable salt thereof or the aforementioned pharmaceutical composition, Said cancer is selected from breast cancer, ovarian cancer, prostate cancer, melanoma, brain tumor, esophageal cancer, gastric cancer, liver cancer, pancreatic cancer, colorectal cancer, lung cancer, kidney cancer, skin cancer, glioblastoma, neuroblastoma Cell tumors and sarcomas.”
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