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 instant application claims priority to provisional application 63/184,904, filed on 05/06/2021, and is a 371 of PCT/US2022/028141, filed on 05/06/2022.
Status of the Claims
Per Applicant’s amendment to the claims, submitted on 06/10/2024, claims 1, 3, 22-24, 26-27, 29, 32-33 are amended, and claims 2, 5-21, 28, 30-31, and 34-35 are canceled. Currently, claims 1, 3-4, 22-27, 29, and 32-33 are pending in the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/09/2024 and 12/29/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112 First Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 32-33 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 32 recites a method for treating cancer. Under broadest reasonable interpretation, the recitation of “cancer” would encompass any and all types of cancers. As is generally understood in the art, cancer can manifest in a plethora of different forms and can be localized in different parts of the body, with differing etiologies and pathophysiology. For instance, basal cell carcinoma and leukemia would both be considered as cancers, despite being significantly different from one another. The instant claim cannot be considered as meeting the written description requirement because Applicant’s disclosure could not reasonably be enabling for the treatment of any and all cancers.
Claim 33 recites a method of inhibiting cancer cell proliferation in a subject in need thereof. Under broadest reasonable interpretation, the instant claim could encompass a subject suffering from any possible metastatic cancer. As is generally understood in the art, such cancers can manifest in a plethora of different forms and can be localized in different parts of the body, with differing etiologies and pathophysiology. For instance, metastatic bladder and bone cancers are different manifestations of metastatic cancer, which are considered as different from one another. The instant claim cannot be considered as meeting the written description requirement because Applicant’s disclosure could not reasonably be enabling for the treatment of any and all metastatic cancers having cancer cell proliferation.
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 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lee (WO2021092525A1) .
The applied reference has a common Applicant and inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim 1 recites a compound of formula(I):
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Lee teaches compounds as WDR5 inhibitors and methods of use of said compounds in treating related diseases such as cancer. Among the compounds taught by Lee is the following compound I-72 (page 65):
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The above compound anticipates a compound of the instant claim wherein:
G1 is
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, wherein R10f is halogen and n is 1
G2 is a five memvered heteroaryl substituted with a C1 alkyl and a C1 fluoroalkyl
R5 is H
R6 is H
R8 is unsubstituted imidazolyl
Claim 3 further limits the compound of claim 1 wherein:
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Compound I-72 of Lee is a compound wherein R8 is
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, and further wherein R20a, R20b, and R20c are each H.
Claim 4 further limits the compound of claim 3 wherein R8 is selected from:
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Compound I-72 of Lee is a compound wherein R8 is
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.
Claim 22 further limits the compound of claim 1 wherein G2 is an optionally substituted 5-6 membered heteroaryl.
The compound of Lee is a compound of formula(I) wherein the corresponding G2 moiety is an unsubstituted 5-membered heteroaryl.
Claim 23 further limits the compound of claim 22 wherein G2 is optionally substituted pyrazolyl.
Compound I-72 of Lee is a compound of formula(I) wherein G2 is substituted pyrazolyl.
Claim 24 further limits the compound of claim 22 wherein G2 is substituted with 1-4 substituents independently selected from halogen, C1-4 alkyl, and C-1-4 fluoroalkyl.
Compound I-72 of Lee is a compound of formula(I) wherein G2 is substituted with a C1 alkyl and C1 fluoroalkyl.
Claim 25 further limits the compound of claim 24 wherein G2 is:
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Compound I-72 of Lee is a compound of formula(I) wherein G2 meets the recited moiety.
Claim 26 further limits the compound of claim 1 wherein R5 is hydrogen.
Compound I-72 of Lee is a compound of formula(I) wherein R5 is hydrogen.
Claim 27 further limits the compound of claim 1 wherein R6 is hydrogen.
Compound I-72 of Lee is a compound of formula(I) wherein R6 is hydrogen.
Claim 29 recites a composition comprising the compound of claim 1.
The teachings of Lee are also directed towards compositions comprising the target compounds.
Claim 32 recites a method of treating cancer comprising administering to a subject in need thereof, a therapeutically effective amount if a compound of claim 1.
The teachings of Lee are directed towards the treatment of cancer (Abstract)1.
Claim 33 recites a method of inhibiting cancer cell proliferation, comprising administering to a subject in need thereof, a therapeutically effective amount if a compound of claim 1.
The teachings of Lee are directed towards the treatment of cancer cell proliferation (Abstract).
Conclusion
Claims 1, 3-4, 22-27, 29, and 32-33 are rejected.
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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 “Isoquinolone compounds and derivatives inhibit WDR5 and associated protein-protein interactions, and the com pounds and their pharmaceutical compositions are useful for treating disorders and conditions in a subject, such as cancer cell proliferation.”