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
Per Applicant’s amendment to the claims, submitted on 07/20/2026, claims 1, 14, 21-13, 25-35, and 43 are amended, claims 2-4, 8, 18-20, and 24 are canceled, and claim 49 is newly added. Currently, claims 1, 13-14, 21-23, and 25-49 are pending in the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/08/2024 and 11/18/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
In accordance with the Election Requirement submitted on 05/19/2026, Applicant has elected, without traverse, the following compound (compound 40) to which the claims will be restricted:
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The election of the above compound species reads on claims 1, 14, 27, 30-31, 36-41, and 43-48. Accordingly, the aforementioned claims will be pending examination and claims 13, 21-23, 25-26, 28-29, 32-35, 42, and 49 are withdrawn from consideration.
The elected compound appears to be free of the art. While the specific compound elected by Applicant may be allowable matter, the withdrawn claims will not be rejoined as all the claims which read on said compound are not allowable.
Claim Objections
Claim 14 is objected to because of the following informalities: Typographical error. The instant claim recites “Formula Iva” but should read “Formula IVa” for consistency with the labeled structure. Appropriate correction is required.
Claims 43, 45, and 47 are objected to as being dependent upon a rejected base claim.
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.
Claim 48 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 48 is indefinite for reciting the term “preventing”, because a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim. The recitation of “preventing axonal degeneration” would encompass a patient population (i.e., subjects) having axonal degeneration as well as those not having axonal degeneration. As the recitation essentially includes all people, it is unclear as to what subjects the method would apply to.
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, 14, 27, 30-31, 36-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (US 2019/0100500 A1).
Claim 1 recites a compound of Formula IIIb:
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a tautomer, solvate, or stereoisomer of the compound thereof.
Lee teaches the following compound (specification [0488]):
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The above compound of Lee anticipates a compound of Formula IIIb wherein:
X1 is N and X2-X4 are each C such that Ring A is pyridinyl
Ra is C1 alkyl and m is 1
Rb and Rc join together to form a 5-membered heterocyclic ring
Rd is H
Re is H (or n is 0)
Claim 14 further limits the compound of claim 1 wherein the compound has the following structural Formula IVa:
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a tautomer thereof, a solvate or stereoisomer of the compound or a tautomer, or a pharmaceutically acceptable salt of the foregoing.
The compound of Lee anticipates a compound of Formula IIIb wherein:
X1 is N and X2-X4 are each C such that Ring A is pyridinyl
Ra is C1 alkyl and m is 1
Rb and Rc join together to form a 5-membered heterocyclic ring
Rd is H
Re is H (or n is 0)
Claim 27 further limits the compound of claim 1 wherein the compound has the following structural Formula VIIc:
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a tautomer thereof, a solvate or a stereoisomer of the compound or the tautomer, or a pharmaceutically acceptable salt of the foregoing.
The compound of Lee is a tautomer of a compound of Formula VIIc. For reference the compound of Lee and its tautomer are provided below:
Compound of Lee
Tautomer
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The tautomeric form of the compound of Lee anticipates a compound of formula VIIIc wherein:
X1 is N
X2 is C
Ra is C1 alkyl
Z2 is N
Z3 is S
D is NH
Claim 30 further limits the compound of claim 1 wherein Ra is selected from -ORs, halogen, -NRpRq, C3-C6 cycloalkyl, CN, and C1-C6 alkyl optionally substituted with 1 to 3 groups selected from halogen, -ORs, and -NRpRq, wherein Rs, for each occurrence, is independently selected from H, phenyl, -CFH₂, -CF2H, -CF₃ and C1-C3 alkyl, and Rp and Ra, for each occurrence, are independently selected from hydrogen, C1-C3 alkyl, phenyl, 9-10 membered aryl, 5-10 membered heteroaryl, wherein the phenyl, 9-10 membered aryl, and 5-10 membered heteroaryl of Rp and R ᵃ are optionally substituted with 1 to 3 groups selected from -COO(C1-C4 alkyl), halogen, OH, -CN, -COOH, -CONH₂, -CONH(C1-C₃ alkyl), -NH(C1-C₃ alkyl), -O(C1-C₃ alkyl), and C1-C4 alkyl.
The compound of Lee is a compound of claim 1 wherein Ra is C1 alkyl.
Claim 31 further limits the compound of claim 1 wherein Ra is selected from -CH3, -CH2CH3, -OCFH₂, -OCF2H, -OCF₃, -OCH₃, CN, CI, OH, NH₂, -NHCH₃, and
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The compound of Lee is a compound of claim 1 wherein Ra is CH3.
Claim 36 further limits the compound of claim 1 wherein Rd is selected from H, CN, -S(=O)wNRpRq, -ORs, halogen, and C1-C₃ alkyl optionally substituted with 1 to 3 groups selected from halogen and wherein R$, for each occurrence, is independently selected from H and C1-C₃ alkyl, and RP¹ and R ¹, for each occurrence, are independently selected from hydrogen and C1-C3 alkyl.
The compound of Lee is a compound of claim 1 wherein Rd is H.
Claim 37 further limits the compound of claim 1 wherein Rd is selected from H, methyl, ethyl, CHF2, CF₃, F, CI, Br, NH₂, OH, OCH3, CN, and -S(=O)2NH₂.
The compound of Lee is a compound of claim 1 wherein Rd is H.
Claim 38 further limits the compound of claim 1 wherein Re is selected from H, halogen, and C1-C3 alkyl optionally substituted with 1 to 3 groups selected from halogen and -NH2.
The compound of Lee is compound of claim 1 wherein Re is H and/or n is 0.
Claim 39 further limits the compound of claim 1 wherein Re is selected from H, methyl, F, and Cl.
The compound of Lee is compound of claim 1 wherein Re is H and/or n is 0.
Claim 40 further limits the compound of claim 1 wherein Rb and Rc, or Rb and Rd join to form a 5- to 7-membered heterocyclic or heteroaromatic ring optionally substituted with 1 to 2 groups selected from CN, halogen, =O, =S, =NH, C1-C₃ alkyl optionally substituted with 1 to 3 groups selected from halogen, and -NRPR9, wherein RP and R ᵃ, for each occurrence, are independently selected from hydrogen, C1-C₃ alkyl, and -C(=O)C1-C₃ alkyl.
The compound of Lee in its tautomeric form (see rejection of claim 27) is a compound wherein Rb and Rc form a 5 membered heterocyclic ring substituted with an =NH group.
Claim(s) 41, 44, and 46 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Bhamidipati (WO 2014/055955 A1).
Claim 41 further limits the compound of claim 1 wherein Rb and Rc, or Rb and Rd join to form a structure selected from:
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Bhamidipati teaches the following compound (specification [0134]):
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The above compound anticipates a compound of claim 1 and the instant claim wherein:
X1 is N and X2-X4 are C, such that Ring A is pyrimidine
Ra is halogen and m is 1
Rb and Rc come together to form
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Rd is H
Re is H or n is 0
Claim 44 recites a pharmaceutical composition comprising a compound of claim 1 and at least one pharmaceutically acceptable carrier.
The teachings of Bhamidipati are directed to compositions comprising their target compounds (specification [0013])1. As Bhamidipati teaches compounds of claim 1 and compositions thereof, the instant claim is accordingly anticipated.
Claim 46 recites a method of treating a disease or condition caused by axonal degeneration, comprising administering to a subject in need thereof, a therapeutically effective amount of a compound according to claim 1, a tautomer thereof, a solvate or stereoisomer of the compound or the tautomer, or a pharmaceutically acceptable salt of the foregoing or a pharmaceutical composition comprising the compound according to claim 1.
The teachings of Bhamidipati are directed to the treatment of at least Alzheimer’s disease (specification [0034])2. Alzheimer’s would be considered as a condition caused by axonal degeneration.
Allowable Subject Matter
The individual compounds of claim 43 appear to be free of the art. However, the claim is not allowable as parent claim 1 is rejected. As iterated previously, Applicant’s elected compound is free of the art. Accordingly, methods of use of said compound in the treatment of ALS, Parkinson’s disease, multiple sclerosis, TBI, diabetic neuropathy, and CIPN (i.e., claim 45), or use of sad compound in modulating SARM1 (ie.e, claim 47) would also be free of the art. Claims 45 and 46 however are not in condition for allowance, as parent claim 1 is rejected. Claims 43, 45, and 46 will be objected to as being dependent upon a previously rejected claim.
Conclusion
Claims 1, 14, 27, 30-31, 36-41, 44, 46 and 48 are rejected.
Claims 43, 45, and 47 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 another aspect, disclosed are pharmaceutical compositions comprising a compound or pharmaceutically acceptable salt of a compound according to formula (I) and a pharmaceutically acceptable carrier, excipient, or diluent.”
2 “In particular the present compounds can be use to treat disorders, such as… impaired neurological function, Alzheimer's disease”
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