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 .
Status of Claims
Claims 1-8 and 10-21 are pending.
Priority
Instant application 18/721,824, filed 06/19/2024 claims priority as follows:
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Information Disclosure Statement
All references from IDS(s) received 11/19/2024 and 1/27/2026 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election without traverse of Group I and the species compound ESATA20 in the reply filed on 08/18/2026 is acknowledged.
The elected species reads on claims 1-5, 8, and 10-15.
Examination will begin with the elected species. In accordance with 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. Please note 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 examined again. 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 further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched, and applicable art was not identified. Therefore, the search was expanded until a limited number of species reading on the claims were identified. See the rejections below. Therefore, the entire scope of the claims has not yet been examined in accordance with Markush search practice. See MPEP 803.02.
The elected and expanded species read on claims 1-5, 7-8, and 10-15. Therefore, claims 6 and 16-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/18/2026.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: QUINOLINE-3-CARBOXAMIDE ANALOGS AS HDAC4 INHIBITORS FOR TREATMENT OF CANCER.
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.
The abstract of the disclosure is objected to because the abstract does not provide the general nature of the compounds such as their class (e.g., quinoline-3-carboxamide analogs). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
Claims 1-4, 7, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by BJORK (WO 1999055678 A1; cited in IDS).
Bjork discloses the compound (page 10, 4th compound listed):
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The above compound reads on formula (I) when R1 is hydrogen, R2 is C3 alkyl, n is 0, and X is a bond. Accordingly, the above compound anticipates claims 1-4 and 7.
Bjork additionally discloses pharmaceutical compositions comprising the compounds disclosed therein and a pharmaceutically acceptable carrier (see e.g. page 21); and discloses administering the compounds of the disclosure to mice, rats, and beagles (pages 18-20). Therefore, Bjork anticipates claim 15.
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 1-5, 7-8, 10-12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over HEDLUND (WO 2001030758 A1; cited in IDS).
Hedlund discloses compounds of formula (I) for the treatment of cancer (Hedlund, abstract):
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Wherein the variables are defined on pages 4-5, and specify that R is selected from hydrogen, methyl, ethyl, n-propyl, iso-propyl, n-butyl, iso-butyl, sec-butyl, and allyl. Hedlund also teaches pharmaceutical compositions at page 22 in the first paragraph.
In particular, Hedlund teaches the compounds N-ethyl-N-phenyl-1,2-dihydro-4-hydroxy-5-methoxy-1-methyl-2-oxo-quinoline-3-carboxamide and N-methyl-N-(4-trifluoromethyl-phenyl)-1,2-dihydro-4-hydroxy-5-methoxy-l-methyl-2-oxo-quinoline-3-carboxamide, having the structures (see pages 9-10 and claims 12 and 28):
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The above compounds do not read on instant Formula (I), because the Formula requires that R2 is selected from hydrogen, C3-C10 alkyl, C3-C6 cycloalkyl, and arylalkyl; with the proviso that if X is a bond, R2 is not hydrogen. The above compounds comprise R2 = methyl or R2 = ethyl, which do not read on the C3-C10 alkyl definition of R2 required by the instant claims. The compounds otherwise comprise the claimed features. See for example the following comparison to compounds recited in instant claim 14:
Instant claim 14
HEDLUND
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The compounds recited in claim 14 are homologs of Hedlund’s compounds.
Finding of prima facie obviousness
MPEP 2144.09, second paragraph, states, “Compounds which are position isomers or
homologs 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). The homolog is expected to be preparable by the same method and to
have generally the same properties. This expectation is then deemed the motivation for
preparing the homolog. This circumstance has arisen many times. See In re Schechter and
LaForge, 98 USPQ 144, 150, which states “a novel useful chemical compound which is homologous or isomeric with compounds of the prior art is unpatentable unless it possesses some
unobvious or unexpected beneficial property not possessed by the prior art compounds.” See In
re Wilder, 166 USPQ 545, 548. Note also In re Deuel 34 USPQ2d 1210, 1214 which states, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds … a known compound may suggest its analogs or
isomers, either geometric isomers (cis v. trans) or position isomers (e.g., ortho v. para).”
Moreover, Hedlund discloses a broad genus and contemplates an amide nitrogen substituent (R in Hedlund’s Formula I) selected from hydrogen, methyl, ethyl, n-propyl, iso-propyl, n-butyl, iso-butyl, sec-butyl, and allyl (page 5, see definition for R). Hedlund therefore provides a suggestion to prepare compounds having homologous alkyl chains attached to the amide nitrogen.
Hedlund’s compounds are disclosed as useful for the treatment of cancer (title, abstract), particularly prostate cancer (page 3, 3rd para.). Therefore, compounds reading on instant claims 1-5, 7-8, 10-12, and 14-15 and their utility for treating cancer would have been prima facie obvious before the effective filing date of the instant application. A skilled artisan would have been motivated to prepare a homolog of Hedlund’s compounds disclosed above with a reasonable expectation of success in obtaining compounds with utility for treating cancer, particularly prostate cancer, which is the utility disclosed for the claimed compounds.
Allowable Subject Matter
Claim 13 is 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.
The closest prior art identified (BJORK and HEDLUND) fails to teach, suggest, or otherwise provide any motivation to modify the compounds disclosed therein by introducing a C3-C6 cycloalkyl substituent on the amide nitrogen.
Conclusion
Claims 1-5, 7-8, 10-12, and 14-15 are rejected. Claim 13 is objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 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 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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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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