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 1-4, 6, 32, 50, 75, 79, 85, 89, 93, 98-101, 103, 104, 106 and 110 are pending in the instant invention. According to the Amendments to the Claims, filed July 16, 2026, claims 5, 7-31, 33-49, 51-74, 76-78, 80-84, 86-88, 90-92, 94-97, 102, 105 and 107-109 were cancelled.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2022/052130, filed December 7, 2022, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application No. 63/287,177, filed December 8, 2021.
Restrictions / Election of Species
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The inventor’s or joint inventor’s provisional election of the following, with traverse, in the reply filed on July 16, 2026, is acknowledged: a) Group II - claims 4, 6, 32 and 50; and b) substituted pyrazolo[1,5-a]pyrimidine of Formula II - p. 50, Compound 2, shown to the right, and hereafter referred to as 4-(5-(3-methylphenethoxy)-2-(pyridin-4-yl)pyrazolo[1,5-a]pyrimidin-7-yl)morpholine, where R1 = -pyridin-4-yl; and R2 = -O(CH2)2-(3-methylphenyl). Claims 4, 32 and 50 read on the elected species. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
Similarly, the inventor or joint inventor should further note that since supposed errors in the restriction requirement were not distinctly and specifically pointed out, the election has been treated as an election, without traverse. See MPEP § 818.03(a).
Likewise, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Next, the inventor or joint inventor should further note that the elected species, shown to the right above, 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 II, for a first Office action and prosecution on the merits.
Moreover, the inventor or joint inventor should further note that claims 1-3, 75, 79, 85, 89, 93, 98-101, 103, 104, 106 and 110 were withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected or cancelled invention, there being no allowable generic or linking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 4, 6, 32 and 50 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 pyrazolo[1,5-a]pyrimidines of the Formula II.
The following title is suggested: SUBSTITUTED PYRAZOLO[1,5-a]PYRIMIDINES AS INHIBITORS OF PIKFYVE.
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 II into the abstract, to overcome this objection.
Claim Objections
Claim 4 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a) and/or 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A compound of Formula II:
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Formula II
or a pharmaceutically acceptable salt or stereoisomer thereof,
wherein:
R1 is pyridin-4-yl;
wherein the pyridin-4-yl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, CN, NO2, alkyl, heteroalkyl, aralkyl, alkenyl, alkynyl, NH2, NH(alkyl), N(alkyl)2, N3, OH, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl;
wherein each cycloalkyl and heterocyclyl substituent is optionally and independently substituted with one, two, three, or four substituents independently selected from the group consisting of halo, CN, NO2, alkyl, heteroalkyl, aralkyl, alkenyl, alkynyl, NH2, NH(alkyl), N(alkyl)2, N3, =NH, OH, =O, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl; and
wherein each aryl and heteroaryl substituent is optionally and independently substituted with one, two, three, or four substituents independently selected from the group consisting of halo, CN, NO2, alkyl, heteroalkyl, aralkyl, alkenyl, alkynyl, NH2, NH(alkyl), N(alkyl)2, N3, OH, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl;
(i) R2 is F, CN, C1-C6 alkyl, C1-C6 alkylene-C6-C10 aryl, C1-C6 heteroalkyl, C1-C6 heteroalkylene-C6-C10 aryl, C2-C6 alkenyl, C2-C6 alkenylene-C6-C10 aryl, C(O)NH2, C(O)NHNHR1A, N(alkyl)2, C2-C9 heterocyclyl, pyrazol-3-yl, pyrazol-5-yl, imidazolyl, oxazolyl, pyridin-2-yl, pyridin-3-yl, pyrimidin-4-yl, pyrazinyl, oxadiazolyl, or thiadiazolyl;
wherein the C1-C6 alkyl, C1-C6 alkylene of C1-C6 alkylene-C6-C10 aryl, C1-C6 heteroalkyl, C1-C6 heteroalkylene of C1-C6 heteroalkylene-C6-C10 aryl, C2-C6 alkenyl, C2-C6 alkenylene of C2-C6 alkenylene-C6-C10 aryl, or N(alkyl)2 is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, CN, NO2, alkyl, heteroalkyl, aralkyl, alkenyl, alkynyl, NH2, NH(alkyl), N(alkyl)2, =NH, N3, OH, =O, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl;
wherein the C2-C9 heterocyclyl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, CN, NO2, alkyl, heteroalkyl, aralkyl, alkenyl, alkynyl, NH2, NH(alkyl), N(alkyl)2, =NH, N3, OH, =O, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl; and
wherein the C6-C10 aryl of C1-C6 alkylene-C6-C10 aryl, C6-C10 aryl of C1-C6 heteroalkylene-C6-C10 aryl, C6-C10 aryl of C2-C6 alkenylene-C6-C10 aryl, pyrazol-3-yl, pyrazol-5-yl, imidazolyl, oxazolyl, pyridin-2-yl, pyridin-3-yl, pyrimidin-4-yl, pyrazinyl, oxadiazolyl, or thiadiazolyl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, CN, NO2, alkyl, heteroalkyl, aralkyl, alkenyl, alkynyl, NH2, NH(alkyl), N(alkyl)2, N3, OH, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl; or
(ii) R2 is:
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or
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;
R1A is H or C2-C10 acyl, wherein the C2-C10 acyl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, CN, NO2, NH2, NH(alkyl), N(alkyl)2, N3, OH, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl;
R2A is C1-C6 alkyl, C3-C6 cycloalkyl, C6-C10 aryl, or C2-C5 heteroaryl;
wherein the C1-C6 alkyl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, CN, NO2, alkyl, heteroalkyl, aralkyl, alkenyl, alkynyl, NH2, NH(alkyl), N(alkyl)2, =NH, N3, OH, =O, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl;
wherein the C3-C6 cycloalkyl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, CN, NO2, alkyl, heteroalkyl, aralkyl, alkenyl, alkynyl, NH2, NH(alkyl), N(alkyl)2, =NH, N3, OH, =O, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl; and
wherein the C6-C10 aryl or C2-C5 heteroaryl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, CN, NO2, alkyl, heteroalkyl, aralkyl, alkenyl, alkynyl, NH2, NH(alkyl), N(alkyl)2, N3, OH, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl; and
R2B is C1-C6 hydroxyalkyl, heteropropyl, heteroisopropyl, cyclopropyl, cyclopropenyl, azetidin-3-yl, piperidinyl, fluorophenyl, methoxyphenyl, pyridin-2-yl, pyridin-3-yl, pyridazin-4-yl, or pyrimidin-5-yl;
wherein the C1-C6 hydroxyalkyl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, CN, NO2, NH2, NH(alkyl), N(alkyl)2, =NH, N3, =O, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl;
wherein the heteropropyl or heteroisopropyl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, CN, NO2, NH2, NH(alkyl), N(alkyl)2, N3, OH, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl;
wherein the piperidinyl is optionally substituted with one or more independently selected C1-C6 alkyl substituents;
wherein the azetidin-3-yl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, CN, NO2, alkyl, heteroalkyl, aralkyl, alkenyl, alkynyl, NH2, NH(alkyl), N(alkyl)2, =NH, N3, OH, =O, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl; and
wherein the cyclopropyl, cyclopropenyl, pyridin-2-yl, pyridin-3-yl, or pyrimidin-5-yl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, CN, NO2, alkyl, heteroalkyl, aralkyl, alkenyl, alkynyl, NH2, NH(alkyl), N(alkyl)2, N3, OH, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 6 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 or stereoisomer thereof, wherein R2 is N(alkyl)2, azetidin-1-yl, azetidin-3-yl, pyrrolidin-2-yl, piperidin-1-yl, 6-oxo-1,5-dihydropyridazinyl, piperazin-1-yl, morpholin-4-yl, N-tetrahydroindazolyl, N-tetrahydropyranopyrazolyl, pyrazol-3-yl, pyrazol-5-yl, imidazolyl, oxazolyl, pyridin-2-yl, pyridin-3-yl, pyrimidin-4-yl, pyrazinyl, oxadiazolyl, or thiadiazolyl;
wherein the 6-oxo-1,5-dihydropyridazinyl is optionally substituted with one, two, or three substituents independently selected from the group consisting of halo, CN, NO2, alkyl, heteroalkyl, aralkyl, alkenyl, alkynyl, NH2, NH(alkyl), N(alkyl)2, =NH, N3, OH, =O, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl; and
wherein the N(alkyl)2 is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, CN, NO2, NH2, NH(alkyl), N(alkyl)2, N3, OH, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl;
wherein the azetidin-1-yl, azetidin-3-yl, pyrrolidin-2-yl, piperidin-1-yl, piperazin-1-yl, morpholin-4-yl, N-tetrahydroindazolyl, or N-tetrahydropyranopyrazolyl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, CN, NO2, alkyl, heteroalkyl, aralkyl, alkenyl, alkynyl, NH2, NH(alkyl), N(alkyl)2, =NH, N3, OH, =O, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl; and
wherein the pyrazol-3-yl, pyrazol-5-yl, imidazolyl, oxazolyl, pyridin-2-yl, pyridin-3-yl, pyrimidin-4-yl, pyrazinyl, oxadiazolyl, or thiadiazolyl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, CN, NO2, alkyl, heteroalkyl, aralkyl, alkenyl, alkynyl, NH2, NH(alkyl), N(alkyl)2, N3, OH, O(phenyl), O(fluorophenyl), SH, cycloalkyl, heterocyclyl, aryl, and heteroaryl.
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(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 or stereoisomer thereof, wherein R2 is:
(i) C1-C6 alkyl, C1-C6 alkylene-C6-C10 aryl, C1-C6 heteroalkyl, C1-C6 heteroalkylene-C6-C10 aryl, C2-C6 alkenyl, C2-C6 alkenylene-C6-C10 aryl, N(alkyl)2, C2-C9 heterocyclyl, pyrazol-3-yl, pyrazol-5-yl, imidazolyl, oxazolyl, pyridin-2-yl, pyridin-3-yl, pyrimidin-4-yl, pyrazinyl, oxadiazolyl, or thiadiazolyl;
wherein the C1-C6 alkyl, C1-C6 alkylene of C1-C6 alkylene-C6-C10 aryl, C1-C6 heteroalkyl, C1-C6 heteroalkylene of C1-C6 heteroalkylene-C6-C10 aryl, C2-C6 alkenyl, C2-C6 alkenylene of C2-C6 alkenylene-C6-C10 aryl, or N(alkyl)2 is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, NO2, NH2, NH(alkyl), N(alkyl)2, =NH, OH, =O, O(phenyl), O(fluorophenyl), C2-C9 heterocyclyl, phenyl, and pyridin-3-yl;
wherein the C2-C9 heterocyclyl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, NO2, C1-C6 alkyl, C1-C6 heteroalkyl, benzyl, NH2, NH(alkyl), N(alkyl)2, =NH, OH, =O, O(phenyl), O(fluorophenyl), C2-C9 heterocyclyl, phenyl, and pyridin-3-yl;
wherein the C6-C10 aryl of C1-C6 alkylene-C6-C10 aryl, C6-C10 aryl of C1-C6 heteroalkylene-C6-C10 aryl, C6-C10 aryl of C2-C6 alkenylene-C6-C10 aryl, pyrazol-3-yl, pyrazol-5-yl, imidazolyl, oxazolyl, pyridin-2-yl, pyridin-3-yl, pyrimidin-4-yl, pyrazinyl, oxadiazolyl, or thiadiazolyl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, NO2, C1-C6 alkyl, C1-C6 heteroalkyl, benzyl, NH2, NH(alkyl), N(alkyl)2, OH, O(phenyl), O(fluorophenyl), C2-C9 heterocyclyl, phenyl, and pyridin-3-yl; or
(ii) R2 is:
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or
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;
R2A is C1-C6 alkyl, C3-C6 cycloalkyl, C6-C10 aryl, or C2-C5 heteroaryl;
wherein the C1-C6 alkyl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, NO2, NH2, NH(alkyl), N(alkyl)2, =NH, OH, =O, O(phenyl), O(fluorophenyl), C2-C9 heterocyclyl, phenyl, and pyridin-3-yl;
wherein the C3-C6 cycloalkyl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, NO2, C1-C6 alkyl, C1-C6 heteroalkyl, benzyl, NH2, NH(alkyl), N(alkyl)2, =NH, OH, =O, O(phenyl), O(fluorophenyl), C2-C9 heterocyclyl, phenyl, and pyridin-3-yl; and
wherein the C6-C10 aryl or C2-C5 heteroaryl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, NO2, C1-C6 alkyl, C1-C6 heteroalkyl, benzyl, NH2, NH(alkyl), N(alkyl)2, OH, O(phenyl), O(fluorophenyl), C2-C9 heterocyclyl, phenyl, and pyridin-3-yl; and
R2B is C1-C6 hydroxyalkyl, heteropropyl, heteroisopropyl, cyclopropyl, cyclopropenyl, azetidin-3-yl, piperidinyl, fluorophenyl, methoxyphenyl, pyridin-2-yl, pyridin-3-yl, pyridazin-4-yl, or pyrimidin-5-yl;
wherein the C1-C6 hydroxyalkyl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, NO2, NH2, NH(alkyl), N(alkyl)2, =NH, =O, O(phenyl), O(fluorophenyl), C2-C9 heterocyclyl, phenyl, and pyridin-3-yl;
wherein the heteropropyl or heteroisopropyl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, NO2, NH2, NH(alkyl), N(alkyl)2, =NH, OH, =O, O(phenyl), O(fluorophenyl), C2-C9 heterocyclyl, phenyl, and pyridin-3-yl;
wherein the piperidinyl is optionally substituted with one or more independently selected C1-C6 alkyl substituents;
wherein the azetidin-3-yl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, NO2, C1-C6 alkyl, C1-C6 heteroalkyl, benzyl, NH2, NH(alkyl), N(alkyl)2, =NH, OH, =O, O(phenyl), O(fluorophenyl), C2-C9 heterocyclyl, phenyl, and pyridin-3-yl; and
wherein the cyclopropyl, cyclopropenyl, pyridin-2-yl, pyridin-3-yl, or pyrimidin-5-yl is optionally substituted with one, two, three, or four substituents independently selected from the group consisting of halo, NO2, C1-C6 alkyl, C1-C6 heteroalkyl, benzyl, NH2, NH(alkyl), N(alkyl)2, OH, O(phenyl), O(fluorophenyl), C2-C9 heterocyclyl, phenyl, and pyridin-3-yl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 50 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 or stereoisomer thereof, wherein R2 is:
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101
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,
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69
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,
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94
170
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,
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68
172
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,
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71
162
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,
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91
136
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,
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88
172
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,
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123
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,
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135
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,
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110
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,
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118
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,
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94
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,
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93
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,
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90
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,
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98
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,
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107
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,
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115
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,
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116
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,
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127
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,
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133
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,
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160
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,
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160
131
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,
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73
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,
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73
88
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,
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media_image93.png
168
110
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,
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media_image94.png
166
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,
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167
98
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,
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149
142
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,
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media_image97.png
148
139
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Greyscale
,
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media_image98.png
150
165
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Greyscale
,
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media_image99.png
158
169
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,
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168
143
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,
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164
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,
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164
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165
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146
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72
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150
123
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151
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74
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, or
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150
121
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.
Appropriate correction is required. See MPEP § 2173.02.
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 4, 6, 32 and 50 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 phrase, optionally substituted, in claim 4, with regard to R1, R1A, R2, R2A, and/or R2B, respectively, is a relative phrase which renders the claims indefinite. The phrase, optionally 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 17, uses open language, such as include and for example, to define the term, substituent, using a boiler plate list of functional groups, such as ayyl, carbocyclyl, 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 pyrazolo[1,5-a]pyrimidines of the Formula II have been rendered indefinite by the use of the phrase, optionally substituted, with regard to R1, R1A, R2, R2A, and/or R2B, 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 4 and 32 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 4 recites the limitations, C1-C6 alkenyl and C6-C10 aryl-C1-C6 alkenyl, respectively, with regard to R2, where the limitations are implausible, resulting in an incomplete valence. Claims are unduly speculative where they define only a portion of a substituted pyrazolo[1,5-a]pyrimidine of the Formula I. Consequently, since incomplete valences are not permitted in the structure of the substituted pyrazolo[1,5-a]-pyrimidines of the Formula I, an essential portion of the substituted pyrazolo[1,5-a]pyrimidines 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 pyrazolo[1,5-a]pyrimidines of the Formula I. {See Ex parte Pedlow and Miner, 90 USPQ 395 (Bd. Pat. App. & Int. 1951)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Similarly, the inventor or joint inventor should further note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Likewise, the inventor or joint inventor should further note that claim 4 recites the broad limitation, C2-C9 heterocyclyl, with regard to R2, and the claim also recites N-tetrahydropyrano-pyrazolyl, N-tetrahydroindazolyl, and 6-oxo-1,5-dihydropyridazin-1-yl, respectively, with regard to R2, which are the narrower statements of the limitation.
Next, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Then, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
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 section of the rejection.
Claim 6 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 6 recites the limitation, The compound of claim 4, wherein R2 is… optionally substituted imidazolyl, in lines 1-10 of the claim. There is insufficient antecedent basis, in claim 4, for this limitation, with respect to the substituted pyrazolo-[1,5-a]pyrimidines of the Formula I. According to claim 4, R2 is not recited as optionally substituted imidazolyl, with respect to the substituted pyrazolo[1,5-a]pyrimidines 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 32 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 a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 32 recites the broad limitations, (1) optionally substituted phenoxy; (2) optionally substituted C1-C6 alkyl; (3) halo; (4) optionally substituted C1-C6 heteroalkyl; and (5) optionally substituted C2-C9 heterocyclyl, respectively, with regard to R2, and the claim also recites (1) 3-fluorophenoxy and 4-fluoro-phenoxy; (2) methyl; (3) bromo; (4) methoxy; and (5) optionally substituted piperidin-3-yl and optionally substituted 1,2,3,6-tetrahydropyridin-3-yl, respectively, with regard to R2, which is the narrower statement of the limitation.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 50 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 6 recites the limitation, The compound of claim 4, wherein R2 is… 3-(5,5-difluoropiperidin-3-yl)pyraxzol-1-yl, etc.. There is insufficient antecedent basis, in claim 4, for this limitation, with respect to the substituted pyrazolo[1,5-a]-pyrimidines of the Formula I. According to claim 4, R2 is not recited as at least 3-(5,5-difluoro-piperidin-3-yl)pyraxzol-1-yl, with respect to the substituted pyrazolo[1,5-a]pyrimidines 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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 4, 32 and 50 in 63/093705 are rejected under 35 U.S.C. § 102(a)(2) as being anticipated by V. Patel in US 2024/0018151.
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83
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221
206
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The inventor or joint inventor should note that the instant invention recites a substituted pyrazolo[1,5-a]pyrimidine of the Formula II, shown to the left, where R1 = -optionally substituted pyridin-4-yl; and R2 is shown to the right above, wherein R2B = -fluorophenyl, respectively, and/or a pharmaceutical composition thereof, as a FYVE-type zinc finger containing phosphoinositide kinase (PIKfyve) inhibitor.
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239
364
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Similarly, the inventor or joint inventor should further note that Patel (US 2024/0018151,
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teaches a substituted pyrazolo[1,5-a]pyrimidine of the Formula II, shown to the right, where R1 = -pyridin-4-yl; and R2 is shown to the left above, wherein R2B = -2-fluorophenyl, respectively, as a synergistic therapeutic agent [p. 7, column 1, row 3; and p. 11 in 63/093705].
Likewise, the inventor or joint inventor should further note that, although not explicitly discussed herein, this reference contains additional species that may anticipate the instantly recited substituted pyrazolo[1,5-a]pyrimidines of the Formula II. Consequently, any amendments to the claims and/or arguments formulated to overcome rejections rendered under 35 U.S.C. § 102 should address this reference as a whole and should not be limited to the species discussed or disclosed explicitly herein.
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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