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 1-5, 11, 14, 16, 18, 25, 51, 52 and 56-63 are pending in the instant invention. According to the Amendments to the Claims, filed November 15, 2024, claims 1, 4, 11, 14, 16, 25, 51, 52, 56-60, 62 and 63 were amended and claims 6-10, 12, 13, 15, 17, 19-24, 26-50, 53-55 and 64-67 were cancelled.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2022/050424, filed November 18, 2022, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application No. 63/281,258, filed November 19, 2021.
Restrictions / Election of Species
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The forthcoming first Office action and prosecution on the merits includes (1) claims 1-5, 11, 14, 16, 18, 25, 51, 52 and 56, drawn to substituted furans of the Formula (I), shown to the right, and/or a pharmaceutical composition thereof; (2) claim 57, drawn to a crystalline form of a substituted furan of the Formula (I), shown to the right above; (3) claim 58, drawn to an amorphous form of a substituted furan of the Formula (I), shown to the right above; (4) claim 59, drawn to a solid form of a substituted furan of the Formula (I), shown to the right above; and (5) claims 60-63, drawn to a method of treating cancer, comprising administering… a substituted furan of the Formula (I), shown to the right above, respectively.
Thus, a first Office action and prosecution on the merits of claims 1-5, 11, 14, 16, 18, 25, 51, 52 and 56-63 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 the substituted furans of the Formula (I).
The following title is suggested: SUBSTITUTED FURANS AS INHIBITORS OF THE ONCOGENIC SHP2 PHOSPHATASE.
Appropriate correction is required.
Specification Objection - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, 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 reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating the structure of Formula (I) into the abstract, to overcome this objection.
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(b), 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, stereoisomer, or tautomer thereof,
wherein:
Y is -O-;
R1 is:
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,
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,
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, or
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;
---- is a single or double bond;
A is -CH2-, -O-, or -S-;
R9 is H, halogen, NO2, C1-C16 alkyl, C2-C16 alkenyl, C2-C16 alkynyl, C(O)NR13R13, C(O)OR13, C(O)SR13, C(S)OR13, C(S)SR13, NR13R13, OR13, SR13, C3-C8 cycloalkyl, C3-C8 cycloalkenyl, heterocycloalkyl, heterocycloalkenyl, or phenyl;
wherein the C1-C16 alkyl, C2-C16 alkenyl, or C2-C16 alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
wherein the C3-C8 cycloalkyl, C3-C8 cycloalkenyl, heterocycloalkyl, or heterocycloalkenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl; and
wherein the phenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
R10 is H, CN, NO2, C1-C16 alkyl, C2-C16 alkenyl, C2-C16 alkynyl, C(O)NR13R13, C(O)OR13, C(O)SR13, C(S)OR13, C(S)SR13, NR13R13, OR13, SR13, C3-C8 cycloalkyl, C3-C8 cycloalkenyl, C3-C8 cycloalkynyl, heterocycloalkyl, heterocycloalkenyl, or phenyl;
wherein the C1-C16 alkyl, C2-C16 alkenyl, or C2-C16 alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
wherein the C3-C8 cycloalkyl, C3-C8 cycloalkenyl, C3-C8 cycloalkynyl, heterocycloalkyl, or heterocycloalkenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl; and
wherein the phenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
R11 is H, CN, NO2, C1-C16 alkyl, C2-C16 alkenyl, C2-C16 alkynyl, C(O)NR13R13, C(O)OR13, C(O)SR13, C(S)OR13, C(S)SR13, NR13R13, OR13, SR13, C3-C8 cycloalkyl, C3-C8 cycloalkenyl, C3-C8 cycloalkynyl, heterocycloalkyl, heterocycloalkenyl, or phenyl;
wherein the C1-C16 alkyl, C2-C16 alkenyl, or C2-C16 alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
wherein the C3-C8 cycloalkyl, C3-C8 cycloalkenyl, C3-C8 cycloalkynyl, heterocycloalkyl, or heterocycloalkenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl; and
wherein the phenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl; or
R10 and R11, taken together with the carbon atoms to which they are attached, form a 1,2-phenylene, wherein the 1,2-phenylene is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
R7 is H, halogen, NO2, C1-C16 alkyl, C2-C16 alkenyl, C2-C16 alkynyl, C(O)NR13R13, C(O)OR13, C(O)SR13, C(S)OR13, C(S)SR13, NR13R13, OR13, SR13, C3-C8 cycloalkyl, C3-C8 cycloalkenyl, heterocycloalkyl, heterocycloalkenyl, or phenyl;
wherein the C1-C16 alkyl, C2-C16 alkenyl, or C2-C16 alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
wherein the C3-C8 cycloalkyl, C3-C8 cycloalkenyl, heterocycloalkyl, or heterocycloalkenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl; and
wherein the phenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
R8 is H, halogen, NO2, C1-C16 alkyl, C2-C16 alkenyl, C2-C16 alkynyl, C(O)NR13R13, C(O)OR13, C(O)SR13, C(S)OR13, C(S)SR13, NR13R13, OR13, SR13, C3-C8 cycloalkyl, C3-C8 cycloalkenyl, heterocycloalkyl, heterocycloalkenyl, or phenyl;
wherein the C1-C16 alkyl, C2-C16 alkenyl, or C2-C16 alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
wherein the C3-C8 cycloalkyl, C3-C8 cycloalkenyl, heterocycloalkyl, or heterocycloalkenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl; and
wherein the phenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
L is a bond;
R2 is C(O)NR12R12;
R3 is F, Cl, Br, or OH;
R4 is H, halogen, NO2, C1-C16 alkyl, C2-C16 alkenyl, C2-C16 alkynyl, C(O)NR13R13, C(O)OR13, C(O)SR13, C(S)OR13, C(S)SR13, NR13R13, OR13, SR13, C3-C8 cycloalkyl, C3-C8 cycloalkenyl, heterocycloalkyl, heterocycloalkenyl, or phenyl;
wherein the C1-C16 alkyl, C2-C16 alkenyl, or C2-C16 alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
wherein the C3-C8 cycloalkyl, C3-C8 cycloalkenyl, heterocycloalkyl, or heterocycloalkenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl; and
wherein the phenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
R5 is H, halogen, NO2, C1-C16 alkyl, C2-C16 alkenyl, C2-C16 alkynyl, C(O)NR13R13, C(O)OR13, C(O)SR13, C(S)OR13, C(S)SR13, NR13R13, OR13, SR13, C3-C8 cycloalkyl, C3-C8 cycloalkenyl, heterocycloalkyl, heterocycloalkenyl, or phenyl;
wherein the C1-C16 alkyl, C2-C16 alkenyl, or C2-C16 alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
wherein the C3-C8 cycloalkyl, C3-C8 cycloalkenyl, heterocycloalkyl, or heterocycloalkenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl; and
wherein the phenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
R6 is H, halogen, NO2, C1-C16 alkyl, C2-C16 alkenyl, C2-C16 alkynyl, C(O)NR13R13, C(O)OR13, C(O)SR13, C(S)OR13, C(S)SR13, NR13R13, OR13, SR13, C3-C8 cycloalkyl, C3-C8 cycloalkenyl, heterocycloalkyl, heterocycloalkenyl, or phenyl;
wherein the C1-C16 alkyl, C2-C16 alkenyl, or C2-C16 alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
wherein the C3-C8 cycloalkyl, C3-C8 cycloalkenyl, heterocycloalkyl, or heterocycloalkenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl; and
wherein the phenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
each R12 is independently H, C1-C16 alkyl, C2-C16 alkenyl, C2-C16 alkynyl, C3-C8 cycloalkyl, C3-C8 cycloalkenyl, heterocycloalkyl, heterocycloalkenyl, or phenyl;
wherein each C1-C16 alkyl, C2-C16 alkenyl, and C2-C16 alkynyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
wherein each C3-C8 cycloalkyl, C3-C8 cycloalkenyl, heterocycloalkyl, and heterocycloalkenyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl; and
wherein each phenyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl; and
each R13 is independently C1-C16 alkyl, C2-C16 alkenyl, C2-C16 alkynyl, C3-C8 cycloalkyl, C3-C8 cycloalkenyl, heterocycloalkyl, heterocycloalkenyl, or phenyl;
wherein each C1-C16 alkyl, C2-C16 alkenyl, and C2-C16 alkynyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
wherein each C3-C8 cycloalkyl, C3-C8 cycloalkenyl, heterocycloalkyl, and heterocycloalkenyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl; and
wherein each phenyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
with the proviso that the compound of Formula (I) is not:
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.
Appropriate correction is required. See MPEP § 2173.02.
Claim 2 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein R1 is:
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Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 2, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein R9 is H.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 2, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein A is -O- or -S-.
Appropriate correction is required. See MPEP § 2173.02.
Claim 5 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein R1 is:
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Appropriate correction is required. See MPEP § 2173.02.
Claim 11 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein R3 is OH.
Appropriate correction is required. See MPEP § 2173.02.
Claim 14 is objected to because of the following informalities: for clarity, precision and to avoid issues under 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 4, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein R10 and R11, taken together with the carbon atoms to which they are attached, form a 1,2-phenylene, wherein the 1,2-phenylene is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl.
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(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 4, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
R10 is H, CN, NO2, C1-C16 alkyl, C2-C16 alkenyl, C2-C16 alkynyl, C(O)NR13R13, C(O)OR13, C(O)SR13, C(S)OR13, C(S)SR13, NR13R13, OR13, SR13, C3-C8 cycloalkyl, C3-C8 cycloalkenyl, C3-C8 cycloalkynyl, heterocycloalkyl, heterocycloalkenyl, or phenyl;
wherein the C1-C16 alkyl, C2-C16 alkenyl, or C2-C16 alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
wherein the C3-C8 cycloalkyl, C3-C8 cycloalkenyl, C3-C8 cycloalkynyl, heterocycloalkyl, or heterocycloalkenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl; and
wherein the phenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl; and
R11 is H, CN, NO2, C1-C16 alkyl, C2-C16 alkenyl, C2-C16 alkynyl, C(O)NR13R13, C(O)OR13, C(O)SR13, C(S)OR13, C(S)SR13, NR13R13, OR13, SR13, C3-C8 cycloalkyl, C3-C8 cycloalkenyl, C3-C8 cycloalkynyl, heterocycloalkyl, heterocycloalkenyl, or phenyl;
wherein the C1-C16 alkyl, C2-C16 alkenyl, or C2-C16 alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl;
wherein the C3-C8 cycloalkyl, C3-C8 cycloalkenyl, C3-C8 cycloalkynyl, heterocycloalkyl, or heterocycloalkenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, oxo, thioxo, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl; and
wherein the phenyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, cyano, nitro, alkyl, haloalkyl, alkylene-aminocarbonyl, alkylene-carboxy, alkylene-alkoxycarbonyl, alkylene-alkylamino, alkylene-arylamino, alkylene-alkoxy, alkylene-thioalkyl, alkylene-alkylsulfonyl, alkylene-arylsulfonyl, alkenyl, alkynyl, acyl, aminocarbonyl, alkylaminocarbonyl, arylaminocarbonyl, alkoxycarbonyl, aralkoxycarbonyl, aryloxycarbonyl, amino, alkylamino, amino-aminoalkyl, arylamino, hydroxy, alkoxy, aralkoxy, aryloxy, thiol, alkylthio, arylthio, alkylsulfonyl, sulfonic acid, heterocyclyl, aryl, arylene-thioalkyl, and heteroaryl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 18 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 14, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein R9 is H.
Appropriate correction is required. See MPEP § 2173.02.
Claim 25 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 1, wherein the compound is selected from the group consisting of:
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or a pharmaceutically acceptable salt or tautomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 51 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
R1 is:
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;
R7 is H, halogen, C1-C6 alkyl, OR13, or SR13;
R8 is H, halogen, C1-C6 alkyl, OR13, or SR13;
R4 is H, halogen, or C1-C6 alkyl;
R5 is H, halogen, or C1-C6 alkyl;
R6 is H, halogen, or C1-C6 alkyl;
each R12 is independently H, C1-C6 alkyl, C3-C6 cycloalkyl, 3- to 10-membered heterocycloalkyl, or phenyl;
wherein each C1-C6 alkyl is optionally and independently substituted with one, two, three, four, or five substituents independently selected from the group consisting of halo, amino, hydroxy, C1-C6 alkoxy, and phenyl;
wherein each C3-C6 cycloalkyl and 3- to 10-membered heterocycloalkyl is optionally and independently substituted with one, two, three, four, or five substituents independently selected from the group consisting of halo, C1-C6 alkyl, amino, hydroxy, C1-C6 alkoxy, and phenyl; and
wherein each phenyl is optionally and independently substituted with one, two, three, four, or five substituents independently selected from the group consisting of halo, C1-C6 alkyl, amino, hydroxy, C1-C6 alkoxy, and phenyl; and
each R13 is independently C1-C6 alkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 52 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 51, wherein the compound is selected from the group consisting of:
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or a pharmaceutically acceptable salt or tautomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 56 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A pharmaceutical composition comprising a pharmaceutically acceptable excipient and a compound of claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 60 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(s):
60. A method for inhibiting src-homology 2 domain-containing phosphatase 2 (SHP2) activity in a patient, wherein the method comprises administering to the patient in need thereof a therapeutically effective dose of a compound of claim 51, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof.
68. The method of claim 60, wherein the patient suffers from cancer.
Appropriate correction is required. See MPEP § 2173.02.
Claim 61 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
69. The method of claim 68, wherein the cancer comprises cells expressing src-homology 2 domain-containing phosphatase 2 (SHP2) that comprises an E76K mutation.
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.
Method of treating cancer, comprising administering… a substituted furan of the Formula (I)
Claims 60-63 are rejected under 35 U.S.C. § 112(a) as failing to comply with the enablement requirement because the claims contain subject matter, particularly a method of treating cancer, comprising administering… a substituted furan of the Formula (I), which was not described in the specification in such a way as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use (perform) the invention commensurate in scope with these claims.
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 present invention, are summarized as follows:
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(a) Breadth of the claims - the breadth of the claims includes a method of treating cancer, comprising administering… a substituted furan of the Formula (I), shown to the right;
(b) Nature of the invention - the nature of the invention is performance of a method of treating cancer, comprising administering… a substituted furan of the Formula (I), shown to the right above;
(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). Similarly, no single drug has been discovered that is effective in treating the myriad of cancers, including, but not limited to, breast cancer and leukemia {See In re Hokum, 226 USPQ 353 (ComrPats 1985)}. Moreover, US 2005/0042674, illustrates the synthesis of substituted furans of the Formula (I), and/or methods of use thereof {Yu, et al. in US 2005/0042674, 2005};
(d) Level of one of ordinary skill in the art - the artisans performing the inventor’s or joint inventor’s method of treating cancer, comprising administering… a substituted furan of the Formula (I) 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 well established that [T]he scope of enablement varies inversely with the degree of unpredictability of the factors involved, and physiological activity is generally considered to be an unpredictable factor {See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970)}.
Moreover, the following excerpt is taken from Hackam, et al., with respect to the poor replication of animal research in human clinical trials {Hackam, et al. JAMA, 296(14), 2006, 1731-1732}:
Only about a third of highly cited animal research translated at the level of human randomized trials. This rate of translation is lower than the recently estimated 44% replication rate for highly cited human studies. Nevertheless, we believe these findings have important implications. First, patients and physicians should remain cautious about extrapolating the findings of prominent animal research to the care of human disease. Second, major opportunities for improving study design and methodological quality are available for preclinical research. Finally, poor replication of even high-quality animal studies should be expected by those who conduct clinical research.
(f) Amount of direction provided by the inventor - the invention lacks direction with respect to making and/or using (performing) a method of treating cancer, comprising administering… a substituted furan of the Formula (I);
(g) Existence of working examples - the disclosure is insufficient to allow extrapolation of the limited examples to enable performing the instantly recited method of treating cancer, comprising administering… a substituted furan of the Formula (I).
Similarly, according to the specification, substituted furans of the Formula (I) are capable of treating a variety of cancers, including, but not limited to, breast cancer and leukemia; however, the specification fails to set forth any convincing in vitro and/or in vivo assays corroborating the alleged activity in association with any cancers, including, but not limited to, breast cancer and leukemia. There is insufficient disclosure to reasonably conclude that the method of treating cancer, comprising administering… a substituted furan of the Formula (I), as recited, would contribute to treatment of any cancers, including, but not limited to, breast cancer and leukemia. Furthermore, the combination of the instant specification and Yu, et al. in US 2005/0042674, lacks adequate credible evidence to support the assertion that a method of treating cancer, comprising administering… a substituted furan of the Formula (I), as recited, would contribute to the prophylaxis of any cancers, including, but not limited to, breast cancer and leukemia, since the inventor or joint inventor has neither provided convincing data for any patient population, nor indicated any art recognized correlation between the disclosed data and the breadth of the claims.
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 and/or use (perform) the invention based on the content of the disclosure - predicting whether a recited compound 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). Furthermore, it is unclear, based on the guidance provided by the specification, whether a substituted furan of the Formula (I), such as N-(4-aminophenyl)-2-hydroxy-5-(5-{[(2Z)-3-oxo-2,3-dihydro-1-benzothiophen-2-ylidene]methyl}furan-2-yl)benzamide, shown to the left above, possesses utility as a therapeutic agent, useful in a method of treating cancer, comprising administering… a substituted furan of the Formula (I). Thus, one of ordinary skill in the art, at the time this invention was made, would have an unreasonable expectation of success and undue experimentation in transferring the in vitro and/or in vivo method of treating cancer, comprising administering… a substituted furan of the Formula (I), wherein the cancer, includes, but is not limited to, breast cancer and leukemia, to any patient population.
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 (perform) 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 (performing) a method of treating cancer, comprising administering… a substituted furan 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.
Claims 1-5, 11, 14, 16, 18, 51 and 56-63 are 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, substituted, in claim 1, with regard to R4, R5, R6, R7, R8, R9, R10, R11, R10 and R11, R12, and R13, respectively, is a relative term which renders the claim indefinite. The term, substituted, 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, on page 22, uses open language, such as including, but not limited to, to define the term, substituted, using a boiler plate list of substituents, such as halo, alkyl, etc., and further discloses that the substituents themselves may be further substituted; however, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the substituted furans of the Formula (I) have been rendered indefinite by the use of the term, substituted, with regard to R4, R5, R6, R7, R8, R9, R10, R11, R10 and R11, R12, and R13, respectively.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claims 1-5, 11, 14, 16, 18, 51 and 56-63 are further 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 1 recites the limitations, C1-C16 substituted or unsubstituted alkenyl and C1-C16 substituted or unsubstituted alkynyl, with regard to R4, R5, R6, R7, R8, R9, R10, R11, R10 and R11, R12, and R13, respectively, where the limitations are implausible, resulting in an incomplete valence. Claims are unduly speculative where they define only a portion of a substituted furan of the Formula (I). Consequently, since incomplete valences are not permitted in the structure of the substituted furans of the Formula (I), an essential portion of the substituted furans of the Formula (I) is indefinite and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the substituted furans of the Formula (I). {See Ex parte Pedlow and Miner, 90 USPQ 395 (Bd. Pat. App. & Int. 1951)}.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 16 is further 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 16 recites the limitation, The compound of claim 4, wherein R10 and R11 are each independently… OR12, SR12,… in lines 1-3 of the claim. There is insufficient antecedent basis, in claim 4, for this limitation, with respect to the substituted furans of the Formula (I). According to claim 4, R10 and R11 are not independently recited as OR12, SR12,…, with respect to the substituted furans of the Formula (I).
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 57 is further 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 57 recites the limitation, A crystalline form of a compound of claim 1,… or a solvate or hydrate thereof, in lines 1-2 of the claim. There is insufficient antecedent basis, in claim 1, for this limitation, with respect to the substituted furans of the Formula (I). According to claim 1, neither solvates, nor hydrates, respectively, are recited, with respect to the substituted furans of the Formula (I).
The examiner suggests amending or cancelling the claim, to overcome this section of the rejection.
Similarly, the inventor or joint inventor should further note that claim 57 recites the physicochemical property, A crystalline form of a compound of claim 1, or a pharmaceutically acceptable salt thereof, or a solvate or hydrate thereof, in lines 1-2 of the claim.
Likewise, the inventor or joint inventor should further note that the aforementioned physicochemical property renders the instant invention ambiguous, vague, incoherent, opaque and/or otherwise unclear to the examiner and fails to meet the statutory requirements of 35 U.S.C. § 112(b), since the limitation merely states a physicochemical property (i.e. crystallinity) without providing any clarity regarding how the physicochemical property is imparted.
Next, the inventor or joint inventor should further note that the instantly recited crystalline physicochemical property does not appear to emanate from and/or does not appear to be an inherent or salient property of the instantly recited substituted furans of the Formula (I).
Then, the inventor or joint inventor should further note that the examiner is uncertain whether the instantly recited substituted furans of the Formula (I) require an additional unrecited component to be admixed therewith, such as a stabilizer, bulking agent, solvent or buffer, to impart the crystalline physicochemical property.
Consequently, the inventor or joint inventor should further note that since the instantly recited substituted furans of the Formula (I) incorporate the aforementioned ambiguous, vague, incoherent, opaque and/or otherwise unclear crystalline physicochemical property, the instantly recited substituted furans of the Formula (I) are rendered indefinite under 35 U.S.C. § 112(b), since one of ordinary skill in the art may not reasonably determine the metes and bounds of the instantly recited substituted furans of the Formula (I) due to an inability to establish the metes and bounds encompassed by the crystalline physicochemical property.
Moreover, the inventor or joint inventor should further note that [A] claim which omits matter disclosed to be essential to the invention, as described in the specification or in other statements of record, may also be rejected under 35 U.S.C. § 112(a), as not enabling. {See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976); and MPEP § 2164.08(c)}.
The examiner suggests amending or cancelling the claim, to overcome this section of the rejection.
Claim 58 is further 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 58 recites the limitation, A crystalline form of a compound of claim 1,… or a solvate or hydrate thereof, in lines 1-2 of the claim. There is insufficient antecedent basis, in claim 1, for this limitation, with respect to the substituted furans of the Formula (I). According to claim 1, neither solvates, nor hydrates, respectively, are recited, with respect to the substituted furans of the Formula (I).
The examiner suggests amending or cancelling the claim, to overcome this section of the rejection.
Similarly, the inventor or joint inventor should further note that claim 58 recites the physicochemical property, An amorphous form of a compound of claim 1, or a pharmaceutically acceptable salt thereof, or a solvate or hydrate thereof, in lines 1-2 of the claim.
Likewise, the inventor or joint inventor should further note that the aforementioned physicochemical property renders the instant invention ambiguous, vague, incoherent, opaque and/or otherwise unclear to the examiner and fails to meet the statutory requirements of 35 U.S.C. § 112(b), since the limitation merely states a physicochemical property (i.e. morphology) without providing any clarity regarding how the physicochemical property is imparted.
Next, the inventor or joint inventor should further note that the instantly recited amorphous physicochemical property does not appear to emanate from and/or does not appear to be an inherent or salient property of the instantly recited substituted furans of the Formula (I).
Then, the inventor or joint inventor should further note that the examiner is uncertain whether the instantly recited substituted furans of the Formula (I) require an additional unrecited component to be admixed therewith, such as a stabilizer, bulking agent, solvent or buffer, to impart the amorphous physicochemical property.
Consequently, the inventor or joint inventor should further note that since the instantly recited substituted furans of the Formula (I) incorporate the aforementioned ambiguous, vague, incoherent, opaque and/or otherwise unclear amorphous physicochemical property, the instantly recited substituted furans of the Formula (I) are rendered indefinite under 35 U.S.C. § 112(b), since one of ordinary skill in the art may not reasonably determine the metes and bounds of the instantly recited substituted furans of the Formula (I) due to an inability to establish the metes and bounds encompassed by the crystalline physicochemical property.
Moreover, the inventor or joint inventor should further note that [A] claim which omits matter disclosed to be essential to the invention, as described in the specification or in other statements of record, may also be rejected under 35 U.S.C. § 112(a), as not enabling. {See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976); and MPEP § 2164.08(c)}.
The examiner suggests amending or cancelling the claim, to overcome this section of the rejection.
Claim 59 is further 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 59 recites the limitation, A crystalline form of a compound of claim 1,… or a solvate or hydrate thereof, in lines 1-2 of the claim. There is insufficient antecedent basis, in claim 1, for this limitation, with respect to the substituted furans of the Formula (I). According to claim 1, neither solvates, nor hydrates, respectively, are recited, with respect to the substituted furans of the Formula (I).
The examiner suggests amending or cancelling the claim, to overcome this section of the rejection.
Similarly, the inventor or joint inventor should further note that claim 59 recites the physicochemical property, A solid form of a compound of claim 1, or a pharmaceutically acceptable salt thereof, or a solvate or hydrate thereof, in lines 1-2 of the claim.
Likewise, the inventor or joint inventor should further note that the aforementioned physicochemical property renders the instant invention ambiguous, vague, incoherent, opaque and/or otherwise unclear to the examiner and fails to meet the statutory requirements of 35 U.S.C. § 112(b), since the limitation merely states a physicochemical property (i.e. morphology) without providing any clarity regarding how the physicochemical property is imparted.
Next, the inventor or joint inventor should further note that the instantly recited solid physicochemical property does not appear to emanate from and/or does not appear to be an inherent or salient property of the instantly recited substituted furans of the Formula (I).
Then, the inventor or joint inventor should further note that the examiner is uncertain whether the instantly recited substituted furans of the Formula (I) require an additional unrecited component to be admixed therewith, such as a stabilizer, bulking agent, solvent or buffer, to impart the solid physicochemical property.
Consequently, the inventor or joint inventor should further note that since the instantly recited substituted furans of the Formula (I) incorporate the aforementioned ambiguous, vague, incoherent, opaque and/or otherwise unclear solid physicochemical property, the instantly recited substituted furans of the Formula (I) are rendered indefinite under 35 U.S.C. § 112(b), since one of ordinary skill in the art may not reasonably determine the metes and bounds of the instantly recited substituted furans of the Formula (I) due to an inability to establish the metes and bounds encompassed by the solid physicochemical property.
Moreover, the inventor or joint inventor should further note that [A] claim which omits matter disclosed to be essential to the invention, as described in the specification or in other statements of record, may also be rejected under 35 U.S.C. § 112(a), as not enabling. {See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976); and MPEP § 2164.08(c)}.
The examiner suggests amending or cancelling the claim, to overcome this section of the 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 57 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 57 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 furans of the Formula (I), as recited in claim 1, are crystalline. Consequently, since the physicochemical property of the substituted furans of the Formula (I), as recited in claim 1, whereby the substituted furans of the Formula (I) are crystalline, fails to result in a further structural limitation to the substituted furans of the Formula (I), as recited in claim 1, and/or fails to include all the limitations of the substituted furans 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 58 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 57 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 furans of the Formula (I), as recited in claim 1, are amorphous. Consequently, since the physicochemical property of the substituted furans of the Formula (I), as recited in claim 1, whereby the substituted furans of the Formula (I) are amorphous, fails to result in a further structural limitation to the substituted furans of the Formula (I), as recited in claim 1, and/or fails to include all the limitations of the substituted furans 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 59 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 59 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 furans of the Formula (I), as recited in claim 1, are solid. Consequently, since the physicochemical property of the substituted furans of the Formula (I), as recited in claim 1, whereby the substituted furans of the Formula (I) are solid, fails to result in a further structural limitation to the substituted furans of the Formula (I), as recited in claim 1, and/or fails to include all the limitations of the substituted furans 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 62 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 62 is rejected under 35 U.S.C. § 112(d) because the recitation of a physicochemical property of a compound administered within a method from which the claim depends, must result in a patentably distinct methodical step in the recited method, in order to be further limiting. In the instant dependent claim, the substituted furans of the Formula (I) administered within the method of treating cancer, as recited in claim 60, inhibit wild type SHP2. Consequently, since the physicochemical property of the substituted furans of the Formula (I) administered within the instantly recited method of treating cancer, whereby the substituted furans of the Formula (I) administered within the instantly recited method of treating cancer inhibit wild type SHP2, fails to result in a further patentably distinct methodical step in the method of treating cancer, as recited in claim 60, and/or fails to include all the limitations of the method of treating cancer, as recited in claim 60, 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 63 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 63 is rejected under 35 U.S.C. § 112(d) because the recitation of a physicochemical property of a compound administered within a method from which the claim depends, must result in a patentably distinct methodical step in the recited method, in order to be further limiting. In the instant dependent claim, the substituted furans of the Formula (I) administered within the method of treating cancer, as recited in claim 60, inhibit SHP2 oncogenic variant E76K. Consequently, since the physicochemical property of the substituted furans of the Formula (I) administered within the instantly recited method of treating cancer, whereby the substituted furans of the Formula (I) administered within the instantly recited method of treating cancer inhibit SHP2 oncogenic variant E76K, fails to result in a further patentably distinct methodical step in the method of treating cancer, as recited in claim 60, and/or fails to include all the limitations of the method of treating cancer, as recited in claim 60, 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, 11, 18, 51 and 57-63 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Yu, et al. in US 2005/0042674.
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The inventor or joint inventor should note that the instant invention recites a substituted furan of the Formula (I), shown to the left, where Y = -O-; R7 = -H; R8 = -H; R1 is shown to the right, wherein A = -S- and R9 = -H; L = -a bond-; R2 = -C(O)NR12R12, wherein R12 = -H and R12 = -substituted C1-C16 alkyl; R3 = -OH; R4 = -H; R5 = -H; and R6 = -H, respectively, as a src-homology 2 domain-containing phosphatase 2 (SHP2) inhibitor.
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Similarly, the inventor or joint inventor should further note that Yu, et al. (US 2005/0042674) teaches a substituted furan of the Formula (I), shown to the right, where Y = -O-; R7 = -H; R8 = -H; R1 is shown to the left, wherein A = -S- and R9 = -H; L = -a bond-; R2 = -C(O)NR12R12, wherein R12 = -H and R12 = -CH2CH2S-(pyridin-4-yl-2,6-dicarboxylic acid); R3 = -OH; R4 = -H; R5 = -H; and R6 = -H, respectively, as a ligand mimic for NAD [Figure 20, compound 13f; and p. 36, Example 18].
The inventor or joint inventor should 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)}.
Similarly, 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)}.
Likewise, 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)}.
Next, 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)}.
Moreover, 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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