DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1, 3, 4, 7, 8, 16, 17, 20, 21, 27, 28, 31, 32, 44, 47, 64-67 and 72 are pending in the instant invention. According to the Amendments to the Claims, filed June 26, 2024, claims 1, 3, 4, 7, 8, 16, 17, 20, 21, 27, 28, 31, 32, 47, 64, 65, 67 and 72 were amended and claims 2, 5, 6, 9-15, 18, 19, 22-26, 29, 30, 33-43, 45, 46, 48-63 and 68-71 were cancelled.
Status of Priority
This invention claims priority under 35 U.S.C. § 119(e) to US Provisional Application No. 63/494,460, filed April 6, 2023.
Restrictions / Election of Species
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The inventor’s or joint inventor’s provisional election of the following, without traverse, in the reply filed on June 10, 2026, is acknowledged: a) Group I - claims 1, 3, 4, 7, 8, 16, 17, 20, 21, 27, 28, 31, 32, 44, 47 and 64-67; and b) substituted indazole of the Formula (I) - p. 235, compound D012, shown to the right below, and hereafter referred to as 2-(3-(2,6-dioxopiperidin-3-yl)-1H-indazol-1-yl)-N-(pyridazin-3-yl)-acetamide, where m = 0; R1 = -H; R2 = -H; R3 = -L3-C(O)NR3aR3b, wherein L3 = -CH2-, R3a = -H and R3b = -pyridazin-3-yl; and R4= -H. Claims 1, 44, 47 and 64-67 read on the elected species. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
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Similarly, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Likewise, the inventor or joint inventor should further note that the elected species, shown to the right, was found to be free of the prior art. Thus, the examiner has expanded the forthcoming prosecution to include all claims relevant to the genus of Group I, for a first Office action and prosecution on the merits.
Moreover, the inventor or joint inventor should further note that claim 72 was withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected or cancelled invention, there being no allowable generic or linking claim.
Thus, a first Office action and prosecution on the merits of claims 1, 3, 4, 7, 8, 16, 17, 20, 21, 27, 28, 31, 32, 44, 47 and 64-67 is contained within.
Specification Objection - Disclosure
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(c). Revisions should particularly address bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests additionally identifying a particular utility for the substituted indazoles of the Formula (I).
The following title is suggested: SUBSTITUTED INDAZOLES AS KINASE INHIBITORS.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), the existing recitation should be replaced with the following recitation:
A compound of Formula (I):
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(I)
or a pharmaceutically acceptable salt, deuteroisotope, stereoisomer, or tautomer thereof,
wherein:
R1 is H, D, C1-6 alkyl, or C1-6 heteroalkyl;
R2 is H or C1-6 alkyl;
(i) R3 is
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;
L3 is C1-6 alkylene, C1-6 heteroalkylene, C3-10 cycloalkylene, or heterocyclylene;
R3a is H, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C(NR1a)NR1bR1c, C(O)R1a, C(O)NR1bR1c, C(O)OR1a, C(O)SR1a, C(S)R1a, C(S)NR1bR1c, C(S)OR1a, S(O)R1a, S(O)NR1bR1c, S(O)2R1a, S(O)2NR1bR1c, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl;
R3b is H, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C(NR1a)NR1bR1c, C(O)R1a, C(O)NR1bR1c, C(O)OR1a, C(O)SR1a, C(S)R1a, C(S)NR1bR1c, C(S)OR1a, S(O)R1a, S(O)NR1bR1c, S(O)2R1a, S(O)2NR1bR1c, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl; or
R3a and R3b, taken together with the nitrogen atom to which they are attached, form a heterocyclyl; and
R4 is H; or
(ii) R3 is H, C1-6 alkyl, or C1-6 heteroalkyl;
R4 is
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or
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;
L4 is C1-6 alkylene, C1-6 heteroalkylene, C3-10 cycloalkylene, or heterocyclylene;
R4a is H, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C(NR1a)NR1bR1c, C(O)R1a, C(O)NR1bR1c, C(O)OR1a, C(O)SR1a, C(S)R1a, C(S)NR1bR1c, C(S)OR1a, S(O)R1a, S(O)NR1bR1c, S(O)2R1a, S(O)2NR1bR1c, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl;
R4b is H, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C(NR1a)NR1bR1c, C(O)R1a, C(O)NR1bR1c, C(O)OR1a, C(O)SR1a, C(S)R1a, C(S)NR1bR1c, C(S)OR1a, S(O)R1a, S(O)NR1bR1c, S(O)2R1a, S(O)2NR1bR1c, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl; or
R4a and R4b, taken together with the nitrogen atom to which they are attached, form a heterocyclyl;
each R6 is independently D, halo, CN, NO2, C1-6 alkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C(NR1a)NR1bR1c, C(O)R1a, C(O)NR1bR1c, C(O)OR1a, C(O)SR1a, C(S)R1a, C(S)NR1bR1c, C(S)OR1a, NR1bR1c, NR1aC(NR1d)NR1bR1c, NR1aC(O)R1d, NR1aC(O)NR1bR1c, NR1aC(O)OR1d, NR1aC(O)SR1d, NR1aC(S)R1d, NR1aC(S)NR1bR1c, NR1aC(S)OR1d, NR1aS(O)R1d, NR1aS(O)NR1bR1c, NR1aS(O)2R1d, NR1aS(O)2NR1bR1c, OR1a, OC(NR1a)NR1bR1c, OC(O)R1a, OC(O)NR1bR1c, OC(O)OR1a, OC(O)SR1a, OC(S)R1a, OC(S)NR1bR1c, OC(S)OR1a, OS(O)R1a, OS(O)NR1bR1c, OS(O)2R1a, OS(O)2NR1bR1c, SR1a, S(O)R1a, S(O)NR1bR1c, S(O)2R1a, S(O)2NR1bR1c, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl;
n is 0, 1, 2, 3, 4, 5, 6, 7, or 8;
a is 0, 1, 2, or 3;
b is 0, 1, 2, or 3;
A is -C(O)-, -C(O)C(O)-, -S(O)-, or -S(O)2-; and
R7 is H, D, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, NR1bR1c, NR1aC(NR1d)NR1bR1c, NR1aC(O)R1d, NR1aC(O)NR1bR1c, NR1aC(O)OR1d, NR1aC(O)SR1d, NR1aC(S)R1d, NR1aC(S)NR1bR1c, NR1aC(S)OR1d, NR1aS(O)R1d, NR1aS(O)NR1bR1c, NR1aS(O)2R1d, NR1aS(O)2NR1bR1c, OR1a, OC(NR1a)NR1bR1c, OC(O)R1a, OC(O)NR1bR1c, OC(O)OR1a, OC(O)SR1a, OC(S)R1a, OC(S)NR1bR1c, OC(S)OR1a, OS(O)R1a, OS(O)NR1bR1c, OS(O)2R1a, OS(O)2NR1bR1c, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl;
each R5 is independently D, halo, CN, NO2, C1-6 alkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C(NR1a)NR1bR1c, C(O)R1a, C(O)NR1bR1c, C(O)OR1a, C(O)SR1a, C(S)R1a, C(S)NR1bR1c, C(S)OR1a, NR1bR1c, NR1aC(NR1d)NR1bR1c, NR1aC(O)R1d, NR1aC(O)NR1bR1c, NR1aC(O)OR1d, NR1aC(O)SR1d, NR1aC(S)R1d, NR1aC(S)NR1bR1c, NR1aC(S)OR1d, NR1aS(O)R1d, NR1aS(O)NR1bR1c, NR1aS(O)2R1d, NR1aS(O)2NR1bR1c, OR1a, OC(NR1a)NR1bR1c, OC(O)R1a, OC(O)NR1bR1c, OC(O)OR1a, OC(O)SR1a, OC(S)R1a, OC(S)NR1bR1c, OC(S)OR1a, OS(O)R1a, OS(O)NR1bR1c, OS(O)2R1a, OS(O)2NR1bR1c, SR1a, S(O)R1a, S(O)NR1bR1c, S(O)2R1a, S(O)2NR1bR1c, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl;
m is 0, 1, 2, or 3;
each R1a is independently H, D, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl;
each R1b is independently H, D, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl;
each R1c is independently H, D, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl; and
each R1d is independently H, D, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl;
wherein each alkyl, alkylene, heteroalkyl, heteroalkylene, alkenyl, alkynyl, cycloalkyl, cycloalkylene, heterocyclyl, heterocyclylene, aryl, aralkyl, and heteroaryl is optionally and independently substituted with one or more independently selected Q substituents;
each Q is independently D, halo, CN, NO2, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C(NRa)NRbRc, C(O)Ra, C(O)NRbRc, C(O)ORa, C(O)SRa, C(S)Ra, C(S)NRbRc, C(S)ORa, NRbRc, NRaC(NRd)NRbRc, NRaC(O)Rd, NRaC(O)NRbRc, NRaC(O)ORd, NRaC(O)SRd, NRaC(S)Rd, NRaC(S)NRbRc, NRaC(S)ORd, =NH, NRaS(O)Rd, NRaS(O)NRbRc, NRaS(O)2Rd, NRaS(O)2NRbRc, ORa, OC(NRa)NRbRc, OC(O)Ra, OC(O)NRbRc, OC(O)ORa, OC(O)SRa, OC(S)Ra, OC(S)NRbRc, OC(S)ORa, =O, OP(O)(ORb)ORc, OS(O)Ra, OS(O)NRbRc, OS(O)2Ra, OS(O)2NRbRc, SRa, S(O)Ra, S(O)NRbRc, S(O)2Ra, S(O)2NRbRc, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl, wherein each C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, and heteroaryl is optionally and independently substituted with one or more independently selected Qa substituents;
each Ra is independently H, D, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl, wherein each C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, and heteroaryl is optionally and independently substituted with one or more independently selected Qa substituents;
each Rb is independently H, D, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl, wherein each C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, and heteroaryl is optionally and independently substituted with one or more independently selected Qa substituents;
each Rc is independently H, D, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl, wherein each C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, and heteroaryl is optionally and independently substituted with one or more independently selected Qa substituents; or
any Rb and Rc, taken together with the nitrogen atom to which they are attached, independently forms a heterocyclyl, wherein each heterocyclyl is optionally and independently substituted with one or more independently selected Qa substituents; and
each Rd is independently H, D, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl, wherein each C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, and heteroaryl is optionally and independently substituted with one or more independently selected Qa substituents;
each Qa is independently D, halo, CN, NO2, C1-6 alkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C(NRe)NRfRg, C(O)Re, C(O)NRfRg, C(O)ORe, C(O)SRe, C(S)Re, C(S)NRfRg, C(S)ORe, NRfRg, NReC(NRh)NRfRg, NReC(O)Rh, NReC(O)NRfRg, NReC(O)ORf, NReC(O)SRf, NReC(S)Rh, NReC(S)NRfRg, NReC(S)ORf, =NH, NReS(O)Rh, NReS(O)NRfRg, NReS(O)2Rh, NReS(O)2NRfRg, ORe, OC(NRe)NRfRg, OC(O)Re, OC(O)NRfRg, OC(O)ORe, OC(O)SRe, OC(S)Re, OC(S)NRfRg, OC(S)ORe, =O, OP(O)(ORf)ORg, OS(O)Re, OS(O)NRfRg, OS(O)2Re, OS(O)2NRfRg, SRe, S(O)Re, S(O)NRfRg, S(O)2Re, S(O)2NRfRg, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl;
each Re is independently H, D, C1-6 alkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl;
each Rf is independently H, D, C1-6 alkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl;
each Rg is independently H, D, C1-6 alkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl; or
any Rf and Rg, taken together with the nitrogen atom to which they are attached, independently forms a heterocyclyl; and
each Rh is independently H, D, C1-6 alkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 1, wherein the compound is of Formula (IV):
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(IV)
or a pharmaceutically acceptable salt, deuteroisotope, stereoisomer, or tautomer thereof,
wherein:
R3 is H, C1-6 alkyl, or C1-6 heteroalkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 1, wherein the compound is of Formula (V):
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(V)
or a pharmaceutically acceptable salt, deuteroisotope, stereoisomer, or tautomer thereof,
wherein:
R3 is H, C1-6 alkyl, or C1-6 heteroalkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 1, wherein the compound is of Formula (VI):
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(VI)
or a pharmaceutically acceptable salt, deuteroisotope, stereoisomer, or tautomer thereof,
wherein:
R3 is H, C1-6 alkyl, or C1-6 heteroalkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 1, wherein the compound is of Formula (VII):
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(VII)
or a pharmaceutically acceptable salt, deuteroisotope, stereoisomer, or tautomer thereof,
wherein:
R3 is H, C1-6 alkyl, or C1-6 heteroalkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 16 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 1, wherein the compound is of Formula (VIII):
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(VIII)
or a pharmaceutically acceptable salt, deuteroisotope, stereoisomer, or tautomer thereof,
wherein:
R3 is H, C1-6 alkyl, or C1-6 heteroalkyl;
each R8 is independently D, halo, CN, NO2, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C(NR1a)NR1bR1c, C(O)R1a, C(O)NR1bR1c, C(O)OR1a, C(O)SR1a, C(S)R1a, C(S)NR1bR1c, C(S)OR1a, NR1bR1c, NR1aC(NR1d)NR1bR1c, NR1aC(O)R1d, NR1aC(O)NR1bR1c, NR1aC(O)OR1d, NR1aC(O)SR1d, NR1aC(S)R1d, NR1aC(S)NR1bR1c, NR1aC(S)OR1d, NR1aS(O)R1d, NR1aS(O)NR1bR1c, NR1aS(O)2R1d, NR1aS(O)2NR1bR1c, OR1a, OC(NR1a)NR1bR1c, OC(O)R1a, OC(O)NR1bR1c, OC(O)OR1a, OC(O)SR1a, OC(S)R1a, OC(S)NR1bR1c, OC(S)OR1a, OS(O)R1a, OS(O)NR1bR1c, OS(O)2R1a, OS(O)2NR1bR1c, SR1a, S(O)R1a, S(O)NR1bR1c, S(O)2R1a, S(O)2NR1bR1c, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl;
p is 0, 1, 2, 3, 4, 5, 6, 7, or 8;
R9 is H, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C(NR1a)NR1bR1c, C(O)R1a, C(O)NR1bR1c, C(O)OR1a, C(O)SR1a, C(S)R1a, C(S)NR1bR1c, C(S)OR1a, S(O)R1a, S(O)NR1bR1c, S(O)2R1a, S(O)2NR1bR1c, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl;
c is 0, 1, 2, or 3; and
d is 0, 1, 2, or 3.
Appropriate correction is required. See MPEP § 2173.02.
Claim 17 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 1, wherein the compound is of Formula (IX):
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(IX)
or a pharmaceutically acceptable salt, deuteroisotope, stereoisomer, or tautomer thereof,
wherein:
R3 is H, C1-6 alkyl, or C1-6 heteroalkyl;
each R8 is independently D, halo, CN, NO2, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C(NR1a)NR1bR1c, C(O)R1a, C(O)NR1bR1c, C(O)OR1a, C(O)SR1a, C(S)R1a, C(S)NR1bR1c, C(S)OR1a, NR1bR1c, NR1aC(NR1d)NR1bR1c, NR1aC(O)R1d, NR1aC(O)NR1bR1c, NR1aC(O)OR1d, NR1aC(O)SR1d, NR1aC(S)R1d, NR1aC(S)NR1bR1c, NR1aC(S)OR1d, NR1aS(O)R1d, NR1aS(O)NR1bR1c, NR1aS(O)2R1d, NR1aS(O)2NR1bR1c, OR1a, OC(NR1a)NR1bR1c, OC(O)R1a, OC(O)NR1bR1c, OC(O)OR1a, OC(O)SR1a, OC(S)R1a, OC(S)NR1bR1c, OC(S)OR1a, OS(O)R1a, OS(O)NR1bR1c, OS(O)2R1a, OS(O)2NR1bR1c, SR1a, S(O)R1a, S(O)NR1bR1c, S(O)2R1a, S(O)2NR1bR1c, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl;
p is 0, 1, 2, 3, 4, 5, 6, 7, or 8;
R9 is H, C1-6 alkyl, C1-6 heteroalkyl, C7-15 aralkyl, C2-6 alkenyl, C2-6 alkynyl, C(NR1a)NR1bR1c, C(O)R1a, C(O)NR1bR1c, C(O)OR1a, C(O)SR1a, C(S)R1a, C(S)NR1bR1c, C(S)OR1a, S(O)R1a, S(O)NR1bR1c, S(O)2R1a, S(O)2NR1bR1c, C3-10 cycloalkyl, C6-14 aryl, heterocyclyl, or heteroaryl;
c is 0, 1, 2, or 3; and
d is 0, 1, 2, or 3.
Appropriate correction is required. See MPEP § 2173.02.
Claim 20 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 16, wherein the compound is of Formula (X):
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(X)
or a pharmaceutically acceptable salt, deuteroisotope, stereoisomer, or tautomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 21 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 17, wherein the compound is of Formula (XI):
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(XI)
or a pharmaceutically acceptable salt, deuteroisotope, stereoisomer, or tautomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 27 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 1, wherein the compound is of Formula (XII):
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(XII)
or a pharmaceutically acceptable salt, deuteroisotope, stereoisomer, or tautomer thereof,
wherein:
R3 is H, C1-6 alkyl, or C1-6 heteroalkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 28 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 1, wherein the compound is of Formula (XIII):
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(XIII)
or a pharmaceutically acceptable salt, deuteroisotope, stereoisomer, or tautomer thereof,
wherein:
R3 is H, C1-6 alkyl, or C1-6 heteroalkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 31 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 1, wherein the compound is of Formula (XIV):
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(XIV)
or a pharmaceutically acceptable salt, deuteroisotope, stereoisomer, or tautomer thereof,
wherein:
R3 is H, C1-6 alkyl, or C1-6 heteroalkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 32 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 1, wherein the compound is of Formula (XV):
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(XV)
or a pharmaceutically acceptable salt, deuteroisotope, stereoisomer, or tautomer thereof,
wherein:
R3 is H, C1-6 alkyl, or C1-6 heteroalkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 44 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 1, wherein the compound is of Formula (XX):
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(XX)
or a pharmaceutically acceptable salt, deuteroisotope, stereoisomer, or tautomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 47 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 1, wherein the compound is of Formula (XXI):
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(XXI)
or a pharmaceutically acceptable salt, deuteroisotope, stereoisomer, or tautomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 66 is objected to because of the following informalities: a) for clarity and precision, The compound of claim 1, wherein the compound is should be replaced with The compound of claim 1, or a stereoisomer thereof, wherein the compound, or stereoisomer thereof, is selected from the group consisting of; b) for clarity and precision, or… D055; should be replaced with and… D055, ; and c) for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), or an enantiomer,… or prodrug thereof should be replaced with or a pharmaceutically acceptable salt, deuteroisotope, or tautomer thereof. Appropriate correction is required. See MPEP § 2173.02.
Claim 67 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
A pharmaceutical composition comprising a pharmaceutically acceptable excipient and the compound of claim 1, or a pharmaceutically acceptable salt, deuteroisotope, stereoisomer, or tautomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. § 112:
(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.
Isotopic variants, solvates, hydrates, and/or prodrugs of substituted indazoles of the Formula (I)
Claims 1, 3, 4, 7, 8, 16, 17, 20, 21, 27, 28, 31, 32, 44, 47, 66 and 67 are rejected under 35 U.S.C. § 112(a) because the specification, while being enabling for substituted indazoles of the Formula (I), does not reasonably provide enablement for isotopic variants, solvates, hydrates, and/or prodrugs of substituted indazoles of the Formula (I). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. Isotopic variants, solvates, hydrates, and/or prodrugs of substituted indazoles of the Formula (I), as recited in claim 1, 3, 4, 7, 8, 16, 17, 20, 21, 27, 28, 31, 32, 44, 47, 66 and 67, respectively, have not been adequately enabled in the specification to allow any person having ordinary skill in the art, at the time this invention was made, to make and/or use isotopic variants, solvates, hydrates, and/or prodrugs of substituted indazoles of the Formula (I).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor or joint inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. {See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986); and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988)}.
The above factors, regarding the instant invention, are summarized as follows:
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(a) Breadth of the claims - the breadth of the claims includes substituted indazoles of the Formula (I), shown to the right below, as well as the myriad of potential isotopic variants, solvates, hydrates, and/or prodrugs formulated from these substituted indazoles of the Formula (I), shown to the right, respectively;
(b) Nature of the invention - the nature of the invention is evaluation of substituted indazoles of the Formula (I), shown to the right above, and/or isotopic variants, solvates, hydrates, and/or prodrugs thereof, and the pharmacokinetic behavior of these substances as kinase inhibitors;
(c) State of the prior art - Nature Reviews: Drug Discovery offers a snapshot of the state of the drug development art. Herein, drug development is stated to follow the widely accepted Ehrlich model which includes: (1) development of a broad synthetic organic chemistry program; (2) subsequent testing of compounds in an appropriate laboratory model for the disease to be treated; and (3) screening of compounds with low toxicity in prospective clinical trials (Jordan, V. C. Nature Reviews: Drug Discovery, 2, 2003, 205). Moreover, CAS Registry Database teaches an instantly recited substituted indazole of the Formula (I) {CAS Registry Database, RN: 1413281-42-1, entered STN: 10 Dec 2012, accessed by Examiner D. M. Willis on February 9, 2026};
(d) Level of one of ordinary skill in the art - the artisans synthesizing the inventor’s or joint inventor’s substituted indazoles of the Formula (I), and/or isotopic variants, solvates, hydrates, and/or prodrugs thereof, would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience;
(e) Level of predictability in the art - Synthetic organic chemistry is quite unpredictable (See In re Marzocchi and Horton 169 USPQ at 367 ¶3). Similarly, it is unclear based on the combination of the instant specification, and the CAS Registry Database, respectively, whether the instantly recited isotopic variants, solvates, hydrates, and/or prodrugs of substituted indazoles of the Formula (I) are enabled. Likewise, the following excerpt is taken from Dörwald, which has relevance to the synthesis of isotopic variants of substituted indazoles of the Formula (I) {Dörwald, F. Zaragoza. Side Reactions in Organic Synthesis: A Guide to Successful Synthesis Design, Weinheim: WILEY-VCH Verlag GmbH & Co. KGaA, 2005, Preface}:
Most non-chemists would probably be horrified if they were to learn how many attempted syntheses fail, and how inefficient research chemists are. The ratio of successful to unsuccessful chemical experiments in a normal research laboratory is far below unity, and synthetic research chemists, in the same way as most scientists, spend most of their time working out what went wrong, and why.
Despite the many pitfalls lurking in organic synthesis, most organic chemistry textbooks and research articles do give the impression that organic reactions just proceed smoothly and that the total synthesis of complex natural products, for instance, is maybe a labor-intensive but otherwise undemanding task. In fact, most syntheses of structurally complex natural products are the result of several years of hard work by a team of chemists, with almost every step requiring careful optimization. The final synthesis usually looks quite different from that originally planned, because of unexpected difficulties encountered in the initially chosen synthetic sequence. Only the seasoned practitioner who has experienced for himself the many failures and frustrations which the development (sometimes even the repetition) of a synthesis usually implies will be able to appraise such work.
Chemists tend not to publish negative results, because these are, as opposed to positive results, never definite (and far too copious).
Next, the following excerpt is taken from Vippagunta, et al., with respect to the synthesis of solvates and hydrates of substituted indazoles of the Formula (I) (Vippagunta, et al. Advanced Drug Delivery Reviews, 48, 2001, 18):
Predicting the formation of solvates or hydrates of a compound and the number of molecules of water or solvent incorporated into the crystal lattice of a compound is complex and difficult. Each solid compound responds uniquely to the possible formation of solvates or hydrates and hence generalizations cannot be made for a series of related compounds. Certain molecular shapes and features favor the formation of crystals without solvent; these compounds tend to be stabilized by efficient packing of molecules in the crystal lattice, whereas other crystal forms are more stable in the presence of water and/or solvents. There may be too many possibilities so that no computer programs are currently available for predicting the crystal structures of hydrates and solvates.
Moreover, the following excerpt is taken from Burger’s, with respect to the synthesis of prodrugs of indazoles of the Formula (I) {Wolff, Manfred E., Ed. Burger’s Medicinal Chemistry and Drug Discovery - Fifth Edition, Volume 1: Principles and Practice, New York: John Wiley & Sons, 1994, 975-977}:
The design of prodrugs in a rational manner requires that the underlying causes which necessitate or stimulate the use of the prodrug approach be defined and clearly understood. It may then be possible to identify the means by which the difficulties can be overcome. The rational design of the prodrug can thus be divided into three basic steps: (1) identification of the drug delivery problem; (2) identification of the physiochemical properties required for optimal delivery; and (3) selection of a prodrug derivative that has the proper physiochemical properties and that will be cleaved in the desired biological compartment.
The difficulty of extrapolating data from animal to humans encountered during toxicokinetic and toxicologic studies with drugs is amplified with prodrugs, since not only metabolism of the active moiety might differ, but also its availability from the prodrug. As a matter of fact, there is presently no published rational for the conduct of animal and human pharmacokinetic programs during prodrug research and development.
(f) Amount of direction provided by the inventor - the invention lacks direction with respect to making and/or using isotopic variants, solvates, hydrates, and/or prodrugs of substituted indazoles of the Formula (I);
(g) Existence of working examples - the inventor or joint inventor has provided sufficient guidance to make and/or use substituted indazoles of the Formula (I); however, the disclosure is insufficient to allow extrapolation of the limited examples to enable the instantly recited isotopic variants, solvates, hydrates, and/or prodrugs of substituted indazoles of the Formula (I). The specification lacks working examples of isotopic variants, solvates, hydrates, and/or prodrugs of substituted indazoles of the Formula (I).
Within the specification, [A]t least one specific operative embodiment or example of the invention must be set forth. The example(s) and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula. See MPEP § 608.01(p) and MPEP § 2173.05.
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(h) Quantity of experimentation needed to make or use the invention based on the content of the disclosure - predicting whether a recited compound, and/or an isotopic variant, solvate, hydrate, and/or prodrug thereof, is in fact one that produces a desired physiological effect at a therapeutic concentration and with useful kinetics, is filled with experimental uncertainty, and without proper guidance, would involve a substantial amount of experimentation (Jordan, V. C. Nature Reviews: Drug Discovery, 2, 2003, 205-213). Similarly, the specification, as originally filed, including any references incorporated therein, fails to provide the necessary support required by 35 U.S.C. § 112(a) to enable the instantly recited isotopic variants, solvates, hydrates, and/or prodrugs of substituted indazoles of the Formula (I). Thus, it is unclear, based on the guidance provided by the specification, whether a hydrate of a substituted indazole of the Formula (I), such as 2-(3-(2,6-dioxopiperidin-3-yl)-1H-indazol-1-yl)-N-(pyridazin-3-yl)acetamide dihydrate, shown to the left above, is either synthetically feasible or possesses utility as a kinase inhibitor.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the invention was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. {See In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
The determination that undue experimentation would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. (See In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404). These factual considerations are discussed comprehensively in MPEP § 2164.08 (scope or breadth of the claims), § 2164.05(a) (nature of the invention and state of the prior art), § 2164.05(b) (level of one of ordinary skill), § 2164.03 (level of predictability in the art and amount of direction provided by the inventor or joint inventor), § 2164.02 (the existence of working examples) and § 2164.06 (quantity of experimentation needed to make or use the invention based on the content of the disclosure).
Based on a preponderance of the evidence presented herein, the conclusion that the inventor or joint inventor is insufficiently enabled for making and/or using isotopic variants, solvates, hydrates, and/or prodrugs of substituted indazoles of the Formula (I), is clearly justified.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claim 20 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 20 recites the limitations, p, R8, and R9, respectively, with regard to Formula (X), where p, R8, and R9, respectively, are indefinite, resulting in an incomplete valence. Claims are unduly speculative where they define only a portion of a substituted indazole of the Formula (X). Consequently, since incomplete valences are not permitted in the structure of the substituted indazoles of the Formula (X), an essential portion of the substituted indazoles of the Formula (X) is indefinite and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the substituted indazoles of the Formula (X). {See Ex parte Pedlow and Miner, 90 USPQ 395 (Bd. Pat. App. & Int. 1951)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 21 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 21 recites the limitations, p, R8, and R9, respectively, with regard to Formula (XI), where p, R8, and R9, respectively, are indefinite, resulting in an incomplete valence. Claims are unduly speculative where they define only a portion of a substituted indazole of the Formula (XI). Consequently, since incomplete valences are not permitted in the structure of the substituted indazoles of the Formula (XI), an essential portion of the substituted indazoles of the Formula (XI) is indefinite and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the substituted indazoles of the Formula (XI). {See Ex parte Pedlow and Miner, 90 USPQ 395 (Bd. Pat. App. & Int. 1951)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 65 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the substituted indazoles of the Formula (I) have been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending or cancelling the claim, to overcome this rejection.
Claim Rejections - 35 U.S.C. § 112(d)
The following is a quotation of the fourth paragraph of 35 U.S.C. § 112:
(d) REFERENCE IN DEPENDENT FORMS. Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 64 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The inventor or joint inventor should note that claim 64 is rejected under 35 U.S.C. § 112(d) because the recitation of a physicochemical property for a compound must result in a further structural limitation in the compound, in order to be further limiting. In the instant dependent claim, the substituted indazole of the Formula (I), as recited in claim 1, is a molecular glue. Consequently, since the physicochemical property of the substituted indazole of the Formula (I), as recited in claim 1, whereby the substituted indazole of the Formula (I) is a molecular glue, fails to result in a further structural limitation to the substituted indazole of the Formula (I), as recited in claim 1, and/or fails to include all the limitations of the substituted indazole of the Formula (I), as recited in claim 1, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Claim 65 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The inventor or joint inventor should note that claim 65 is rejected under 35 U.S.C. § 112(d) because the recitation of a physicochemical property for a compound must result in a further structural limitation in the compound, in order to be further limiting. In the instant dependent claim, the substituted indazole of the Formula (I), as recited in claim 1, has a molecular weight of no greater than about 600 Da. Consequently, since the physicochemical property of the substituted indazole of the Formula (I), as recited in claim 1, whereby the substituted indazole of the Formula (I) has a molecular weight of no greater than about 600 Da, fails to result in a further structural limitation to the substituted indazole of the Formula (I), as recited in claim 1, and/or fails to include all the limitations of the substituted indazole of the Formula (I), as recited in claim 1, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Claim Rejections - 35 U.S.C. § 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.
Claims 1, 3, 7, 16, 20, 64 and 65 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by the CAS Registry Database.
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The inventor or joint inventor should note that the instant invention recites a substituted indazole of the Formula (I), shown to the left, where m = 0; R1 = -H; R2 = -H; R3 = -C1-6 alkyl; and R4= -O-L4-C(O)NR4aR4b, wherein L4 = -C1-6 alkylene- and R4a and R4b, taken together with the nitrogen atom to which they are attached, form a heterocyclyl, respectively, as a protein kinase inhibitor.
Similarly, the inventor or joint inventor should further note that the CAS Registry Database teaches a substituted indazole of the Formula (I), shown to the right above, where m = 0; R1 = -H; R2 = -H; R3 = -CH3; and at C-7, R4= -O-L4-C(O)NR4aR4b, wherein L4 = -CH2- and R4a and R4b, taken together with the nitrogen atom to which they are attached, form piperazin-1-yl, respectively, as an intermediate in the synthesis of a KRAS protein degrader [CAS Registry Database, RN: 2908754-86-7, entered STN: 12 Mar 2023, accessed by Examiner D. M. Willis on June 12, 2026].
Likewise, the inventor or joint inventor should further note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Next, the inventor or joint inventor should further note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Then, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Moreover, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Also, the inventor or joint inventor should further note that in the event the determination of the status of the invention as subject to AIA 35 U.S.C. § 102 (or as subject to pre-AIA 35 U.S.C. § 102) is incorrect, any correction of the statutory basis for the instant 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.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
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