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 1-19 are pending in the instant invention.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2021/036424, filed June 8, 2021, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application No. 63/036,390, filed June 8, 2020.
Although the inventor’s or joint inventor’s claim for the benefit of a prior-filed invention under 35 U.S.C. § 119(e) is acknowledged, the inventor or joint inventor has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. § 119(e) as follows:
The later-filed invention must be an invention for a patent, for an invention which is also disclosed in the prior-filed invention (the provisional invention). The disclosure of the invention in the prior-filed invention and in the later-filed invention must be sufficient to comply with the requirements of 35 U.S.C. § 112(a). {See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)}.
The specification of the prior-filed invention, US Provisional Application No. 63/036,390, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. § 112(a) for one or more claims of this invention for the following reason: the specification in the instant invention has been amended with respect to the scope of formula I, which now discloses a proviso, and is no longer coextensive with that of US Provisional Application No. 63/036,390.
Consequently, since the specification of US Provisional Application No. 63/036,390 lacks adequate support or enablement for one or more claims of the elected invention of Group I, as defined below in Restrictions / Election of Species, and in the manner provided by 35 U.S.C. § 112(a), the first Office action on the merits of all relevant claims drawn to Group I will be prosecuted according to the earliest effective filing date afforded this invention, which is that of International Application No. PCT/US2021/036424, filed June 8, 2021.
Restrictions / Election of Species
PNG
media_image1.png
200
400
media_image1.png
Greyscale
The inventor’s or joint inventor’s provisional election of the following, without traverse, in the reply filed on October 22, 2025, is acknowledged: a) Group I - claims 1-10 and 19; and b) substituted piperazine of formula I - p. 10, SLU-2633, shown to the right below, and hereafter referred to as 1-(4-([1,2,4]triazolo[4,3-b]pyridazin-6-yl)-piperazin-1-yl)-2-(3,4-dichlorophenyl)ethan-1-one, where R1a = -H; R1b = -H; R1c = -H; R2 = -H; R3a = -H; R3b = -H; R4 = -H; R5 = -Cl; R6 = -Cl; R7 = -H; and R8 = -H. Claims 1-4, 6, 8-10 and 19 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 the requirement is still deemed proper and is therefore made FINAL.
Likewise, the inventor or joint inventor should further note that the elected species, shown to the right 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 I, for a first Office action and prosecution on the merits.
PNG
media_image2.png
200
400
media_image2.png
Greyscale
Moreover, the inventor or joint inventor should further note that claims 11-18 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 1-10 and 19 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 identifying: a) the substituted piperazines of the formula I; and b) a particular utility for the substituted piperazines of the formula I.
The following title is suggested: SUBSTITUTED PIPERAZINES FOR TREATING CRYPTOSPORIDIUM INFECTIONS.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a) and/or 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A compound of formula I:
PNG
media_image3.png
200
400
media_image3.png
Greyscale
I
or a pharmaceutically acceptable salt or stereoisomer thereof,
wherein:
R1a is H, alkyl, aralkyl, alkenyl, alkynyl, cycloalkyl, aryl, or heteroaryl;
wherein the alkyl, alkyl of aralkyl, alkenyl, or alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, NO2, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl;
wherein the cycloalkyl is optionally substituted with one, two, or three substituents independently selected from the group consisting of halogen, NO2, alkyl, haloalkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, NRbRb, OH, ORa, =O, aryl, haloaryl, and heteroaryl;
wherein the aryl of aralkyl or aryl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, alkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, OH, ORa, aryl, and heteroaryl; and
wherein the heteroaryl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, NO2, alkyl, haloalkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl;
R1b is H, alkyl, aralkyl, alkenyl, alkynyl, cycloalkyl, aryl, or heteroaryl;
wherein the alkyl, alkyl of aralkyl, alkenyl, or alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, NO2, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl;
wherein the cycloalkyl is optionally substituted with one, two, or three substituents independently selected from the group consisting of halogen, NO2, alkyl, haloalkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, NRbRb, OH, ORa, =O, aryl, haloaryl, and heteroaryl;
wherein the aryl of aralkyl or aryl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, alkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, OH, ORa, aryl, and heteroaryl; and
wherein the heteroaryl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, NO2, alkyl, haloalkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl;
R1c is H, alkyl, aralkyl, alkenyl, alkynyl, cycloalkyl, aryl, or heteroaryl;
wherein the alkyl, alkyl of aralkyl, alkenyl, or alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, NO2, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl;
wherein the cycloalkyl is optionally substituted with one, two, or three substituents independently selected from the group consisting of halogen, NO2, alkyl, haloalkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, NRbRb, OH, ORa, =O, aryl, haloaryl, and heteroaryl;
wherein the aryl of aralkyl or aryl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, alkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, OH, ORa, aryl, and heteroaryl; and
wherein the heteroaryl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, NO2, alkyl, haloalkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl;
each R2 is independently H, alkyl, alkenyl, or alkynyl, wherein the alkyl, alkenyl, or alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, NO2, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl;
R3a is H, halogen, alkyl, alkenyl, alkynyl, NH2, or OH, wherein the alkyl, alkenyl, or alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, NO2, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl;
R3b is H, halogen, alkyl, alkenyl, alkynyl, NH2, or OH, wherein the alkyl, alkenyl, or alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, NO2, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl; or
R3a and R3b, taken together with the carbon atom to which they are attached, form -C(O)-; or
R3a and R3b, taken together with the carbon atom to which they are attached, form a ring;
R4 is H, halogen, alkyl, alkenyl, or alkynyl, wherein the alkyl, alkenyl, or alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, NO2, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl;
R5 is H, halogen, CN, NO2, alkyl, aralkyl, (CH2)nNHC(O)alkyl, alkenyl, alkynyl, C(O)NR’R”, C(O)OH, C(O)ORa, C(O)aryl, C(O)heteroaryl, OH, O(alkyl), O(cycloalkyl), O(aryl), O(heteroaryl), SF5, S(O)2Ra, S(O)2NR’R”, cycloalkyl, aryl, or heteroaryl;
wherein the alkyl, alkyl of (CH2)nNHC(O)alkyl, alkyl of aralkyl, alkenyl, alkynyl, or O(alkyl) is optionally substituted with one or more substituents independently selected from the group consisting of halogen, NO2, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl;
wherein the cycloalkyl of O(cycloalkyl) or cycloalkyl is optionally substituted with one, two, or three substituents independently selected from the group consisting of halogen, NO2, alkyl, haloalkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, NRbRb, OH, ORa, =O, aryl, haloaryl, and heteroaryl;
wherein the aryl of aralkyl, aryl of C(O)aryl, aryl of O(aryl), or aryl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, alkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, OH, ORa, aryl, and heteroaryl; and
wherein the heteroaryl of C(O)heteroaryl, heteroaryl of O(heteroaryl), or heteroaryl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, NO2, alkyl, haloalkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl; or
R4 and R5, taken together with the carbon atoms to which they are attached, form a ring;
R6 is H, halogen, CN, NO2, alkyl, aralkyl, (CH2)nNHC(O)alkyl, alkenyl, alkynyl, C(O)NR’R”, C(O)OH, C(O)ORa, C(O)aryl, C(O)heteroaryl, OH, O(alkyl), O(cycloalkyl), O(aryl), O(heteroaryl), SF5, S(O)2Ra, S(O)2NR’R”, cycloalkyl, aryl, or heteroaryl;
wherein the alkyl, alkyl of (CH2)nNHC(O)alkyl, alkyl of aralkyl, alkenyl, alkynyl, or O(alkyl) is optionally substituted with one or more substituents independently selected from the group consisting of halogen, NO2, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl;
wherein the cycloalkyl of O(cycloalkyl) or cycloalkyl is optionally substituted with one, two, or three substituents independently selected from the group consisting of halogen, NO2, alkyl, haloalkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, NRbRb, OH, ORa, =O, aryl, haloaryl, and heteroaryl;
wherein the aryl of aralkyl, aryl of C(O)aryl, aryl of O(aryl), or aryl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, alkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, OH, ORa, aryl, and heteroaryl; and
wherein the heteroaryl of C(O)heteroaryl, heteroaryl of O(heteroaryl), or heteroaryl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, NO2, alkyl, haloalkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl; or
R5 and R6, taken together with the carbon atoms to which they are attached, form a ring;
R7 is H, halogen, CN, NO2, alkyl, aralkyl, (CH2)nNHC(O)alkyl, alkenyl, alkynyl, C(O)NR’R”, C(O)OH, C(O)ORa, C(O)aryl, C(O)heteroaryl, OH, O(alkyl), O(cycloalkyl), O(aryl), O(heteroaryl), SF5, S(O)2Ra, S(O)2NR’R”, cycloalkyl, aryl, or heteroaryl;
wherein the alkyl, alkyl of (CH2)nNHC(O)alkyl, alkyl of aralkyl, alkenyl, alkynyl, or O(alkyl) is optionally substituted with one or more substituents independently selected from the group consisting of halogen, NO2, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl;
wherein the cycloalkyl of O(cycloalkyl) or cycloalkyl is optionally substituted with one, two, or three substituents independently selected from the group consisting of halogen, NO2, alkyl, haloalkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, NRbRb, OH, ORa, =O, aryl, haloaryl, and heteroaryl;
wherein the aryl of aralkyl, aryl of C(O)aryl, aryl of O(aryl), or aryl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, alkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, OH, ORa, aryl, and heteroaryl; and
wherein the heteroaryl of C(O)heteroaryl, heteroaryl of O(heteroaryl), or heteroaryl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, NO2, alkyl, haloalkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl; or
R6 and R7, taken together with the carbon atoms to which they are attached, form a ring;
R8 is H, halogen, alkyl, alkenyl, or alkynyl, wherein the alkyl, alkenyl, or alkynyl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, NO2, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl; or
R7 and R8, taken together with the carbon atoms to which they are attached, form a ring;
each R’ is independently H, alkyl, alkenyl, alkynyl, or cycloalkyl;
wherein each alkyl, alkenyl, and alkynyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halogen, NO2, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl; and
wherein each cycloalkyl is optionally and independently substituted with one, two, or three substituents independently selected from the group consisting of halogen, NO2, alkyl, haloalkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, NRbRb, OH, ORa, =O, aryl, haloaryl, and heteroaryl;
each R” is independently H, alkyl, alkenyl, alkynyl, or cycloalkyl;
wherein each alkyl, alkenyl, and alkynyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halogen, NO2, C(O)OH, C(O)ORa, NRbRb, OH, ORa, aryl, haloaryl, and heteroaryl; and
wherein each cycloalkyl is optionally and independently substituted with one, two, or three substituents independently selected from the group consisting of halogen, NO2, alkyl, haloalkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, NRbRb, OH, ORa, =O, aryl, haloaryl, and heteroaryl; or
qny R’ and R”, taken together with the nitrogen atom to which they are attached, independently forms a heterocyclic ring, wherein each heterocyclic ring is independently bonded via a nitrogen atom;
each Ra is independently C1-C6 alkyl, C2-C6 alkenyl, C2-C6 alkynyl, or C3-C6 cycloalkyl;
wherein each C1-C6 alkyl, C2-C6 alkenyl, and C2-C6 alkynyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halogen, NO2, C(O)OH, C(O)O(alkyl), C(O)O(cycloalkyl), NRbRb, OH, O(alkyl), O(cycloalkyl), aryl, haloaryl, and heteroaryl; and
wherein each C3-C6 cycloalkyl is optionally and independently substituted with one, two, or three substituents independently selected from the group consisting of halogen, NO2, alkyl, haloalkyl, alkenyl, alkynyl, C(O)OH, C(O)O(alkyl), C(O)O(cycloalkyl), NRbRb, OH, O(alkyl), O(cycloalkyl), =O, aryl, haloaryl, and heteroaryl;
each Rb is independently H, C1-C10 alkyl, benzyl, C2-C10 alkenyl, C2-C10 alkynyl, C(O)Ra, C(O)ORa, S(O)2Ra, C3-C10 cycloalkyl, phenyl, or heteroaryl;
wherein each C1-C10 alkyl, CH2 of benzyl, C2-C10 alkenyl, and C2-C10 alkynyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halogen, NO2, C(O)OH, C(O)ORa, NH2, OH, ORa, aryl, haloaryl, and heteroaryl; and
wherein each C3-C10 cycloalkyl is optionally and independently substituted with one, two, or three substituents independently selected from the group consisting of halogen, NO2, alkyl, haloalkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, NH2, OH, ORa, =O, aryl, haloaryl, and heteroaryl;
wherein each phenyl of benzyl and phenyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halogen, alkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, OH, ORa, aryl, and heteroaryl; and
wherein each heteroaryl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halogen, NO2, alkyl, haloalkyl, alkenyl, alkynyl, C(O)OH, C(O)ORa, NH2, OH, ORa, aryl, haloaryl, and heteroaryl; or
qny Rb and Rb, taken together with the nitrogen atom to which they are attached, independently forms a heterocyclic ring, wherein each heterocyclic ring is independently bonded via a nitrogen atom; and
each n is independently 1, 2, 3, or 4;
with the proviso that the compound of formula I is not selected from the group consisting of:
PNG
media_image4.png
437
609
media_image4.png
Greyscale
PNG
media_image5.png
750
492
media_image5.png
Greyscale
PNG
media_image6.png
753
438
media_image6.png
Greyscale
PNG
media_image7.png
740
473
media_image7.png
Greyscale
PNG
media_image8.png
787
406
media_image8.png
Greyscale
PNG
media_image9.png
754
477
media_image9.png
Greyscale
PNG
media_image10.png
753
418
media_image10.png
Greyscale
PNG
media_image10.png
753
418
media_image10.png
Greyscale
PNG
media_image10.png
753
418
media_image10.png
Greyscale
PNG
media_image11.png
727
435
media_image11.png
Greyscale
PNG
media_image11.png
727
435
media_image11.png
Greyscale
PNG
media_image11.png
727
435
media_image11.png
Greyscale
PNG
media_image11.png
727
435
media_image11.png
Greyscale
PNG
media_image11.png
727
435
media_image11.png
Greyscale
PNG
media_image12.png
741
469
media_image12.png
Greyscale
.
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 or stereoisomer thereof, wherein:
R1a is H, CH3, CH2-phemyl, CF3, cyclopropyl, phenyl, or 2-(trifluoromethyl)pyridin-4-yl;
R1b is H or CH3; and
R1c is H or CH3.
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 1, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein each R2 is independently H or CH3.
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 1, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein R4 is H, F, or Cl.
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 or stereoisomer thereof, wherein R4 and R5, taken together with the carbon atoms to which they are attached, form a ring.
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 1, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:
R5 is H, F, Cl, Br, CN, NO2, CH3, CH2F, CHF2, CF3, CH2NHC(O)CH(CH3)2, CH2NHcyclopropyl, CH2N(CH3)2, CH2OH, CH2OCH3, CH2-pyrrolidin-1-yl, CH2-piperidin-1-yl, CH2-morpholin-4-yl, CH2-phenyl, CH2CH3, CF2CH3, CF2CF3, CH2CH2-phenyl, CH2CH2CH2NHC(O)OC(CH3)3, CH(CH3)2, C(CH3)3, C≡CH, C≡CCH3, C≡CCH2NH2, C≡CCH2NHC(O)OC(CH3)3, C(O)NH2, C(O)NHCH3, C(O)NHCH2-phenyl, C(O)NHCH2CH2OH, C(O)NHcyclopropyl, C(O)N(CH3)2, C(O)OH, C(O)pyrrolidin-1-yl, C(O)-(4-hydroxyphenyl), OCH3, OCF3, O(phenyl), O(benzo[d][1,2,3]triazol-1-yl), SF5, S(O)2CH3, S(O)2NH2, S(O)2NHCH3, S(O)2NHcyclopropyl, S(O)2N(CH3)2, S(O)2pyrrolidin-1-yl, cyclopropyl, phenyl, or 4-fluorophenyl;
R6 is H, F, Cl, Br, CN, NO2, CH3, CH2F, CHF2, CF3, CH2NHC(O)CH(CH3)2, CH2NHcyclopropyl, CH2N(CH3)2, CH2OH, CH2OCH3, CH2-pyrrolidin-1-yl, CH2-piperidin-1-yl, CH2-morpholin-4-yl, CH2-phenyl, CH2CH3, CF2CH3, CF2CF3, CH2CH2-phenyl, CH2CH2CH2NHC(O)OC(CH3)3, CH(CH3)2, C(CH3)3, C≡CH, C≡CCH3, C≡CCH2NH2, C≡CCH2NHC(O)OC(CH3)3, C(O)NH2, C(O)NHCH3, C(O)NHCH2-phenyl, C(O)NHCH2CH2OH, C(O)NHcyclopropyl, C(O)N(CH3)2, C(O)OH, C(O)pyrrolidin-1-yl, C(O)-(4-hydroxyphenyl), OCH3, OCF3, O(phenyl), O(benzo[d][1,2,3]triazol-1-yl), SF5, S(O)2CH3, S(O)2NH2, S(O)2NHCH3, S(O)2NHcyclopropyl, S(O)2N(CH3)2, S(O)2pyrrolidin-1-yl, cyclopropyl, phenyl, or 4-fluorophenyl; and
R5 is H, F, Cl, Br, CN, NO2, CH3, CH2F, CHF2, CF3, CH2NHC(O)CH(CH3)2, CH2NHcyclopropyl, CH2N(CH3)2, CH2OH, CH2OCH3, CH2-pyrrolidin-1-yl, CH2-piperidin-1-yl, CH2-morpholin-4-yl, CH2-phenyl, CH2CH3, CF2CH3, CF2CF3, CH2CH2-phenyl, CH2CH2CH2NHC(O)OC(CH3)3, CH(CH3)2, C(CH3)3, C≡CH, C≡CCH3, C≡CCH2NH2, C≡CCH2NHC(O)OC(CH3)3, C(O)NH2, C(O)NHCH3, C(O)NHCH2-phenyl, C(O)NHCH2CH2OH, C(O)NHcyclopropyl, C(O)N(CH3)2, C(O)OH, C(O)pyrrolidin-1-yl, C(O)-(4-hydroxyphenyl), OCH3, OCF3, O(phenyl), O(benzo[d][1,2,3]triazol-1-yl), SF5, S(O)2CH3, S(O)2NH2, S(O)2NHCH3, S(O)2NHcyclopropyl, S(O)2N(CH3)2, S(O)2pyrrolidin-1-yl, cyclopropyl, phenyl, or 4-fluorophenyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 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 or stereoisomer thereof, wherein:
R4 and R5, taken together with the carbon atoms to which they are attached, form a ring; or
R5 and R6, taken together with the carbon atoms to which they are attached, form a ring; or
R6 and R7, taken together with the carbon atoms to which they are attached, form a ring; or
R7 and R8, taken together with the carbon atoms to which they are attached, form a ring.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 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 or stereoisomer thereof, wherein R8 is H, F, or Cl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 9 is objected to because of the following informalities: a) for clarity and precision, The compound of claim 1, wherein the compound is should be replaced with The compound of claim 1, wherein the compound is selected from the group consisting of; b) for clarity, or should be replaced with and before the last species; and c) for clarity and precision, , or a pharmaceutically acceptable salt or stereoisomer thereof should be inserted before the period. Appropriate correction is required. See MPEP § 2173.02.
Claim 10 is objected to because of the following informalities: a) for clarity and precision, The compound of claim 9, wherein the compound is should be replaced with The compound of claim 9, wherein the compound is selected from the group consisting of; b) for clarity, or should be replaced with and before the last species; and c) for clarity and precision, , or a pharmaceutically acceptable salt or stereoisomer thereof should be inserted before the period. Appropriate correction is required. See MPEP § 2173.02.
Claim 19 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation(s):
19. A pharmaceutical composition comprising a pharmaceutically acceptable carrier or excipient and at least one compound of claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof.
20. A kit comprising at least one compound of claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof, and instructions on administration details to an individual who has been diagnosed with or who is at risk of getting a Cryptosporidium infection, wherein the details comprise at least one or more of the following: dosage, frequency, and length of time for administration of the compound, or a pharmaceutically acceptable salt or stereoisomer thereof.
21. A kit comprising the pharmaceutical composition of claim 19, materials to prepare the pharmaceutical composition, and instructions on administration details to an individual who has been diagnosed with or who is at risk of getting a Cryptosporidium infection, wherein the details comprise at least one or more of the following: dosage, frequency, and length of time for administration of the pharmaceutical composition.
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 1-8 and 19 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 R1a, R1b, R1c, R2, R3a, R3b, R4, R5, R6, R7, R8, R’, and/or R”, respectively, is a relative phrase which renders the claims indefinite. The term, substituted, is not defined by the claims, 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 pages 3-4, uses open language, such as include, but are not limited to, to define the term, substituted, using a boiler plate list of functional groups, such as halogen, etc.; however, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the substituted piperazines of the formula I have been rendered indefinite by the use of the term, substituted, with regard to R1a, R1b, R1c, R2, R3a, R3b, R4, R5, R6, R7, R8, R’, and/or R”, 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.
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 1, wherein R5, R6 and R7 are independently… S(O)2CH3, CO2H (and salts and deprotonated forms), or CH2-(4,4-difluoropiperidin-1-yl), in lines 1-4 of the claim. There is insufficient antecedent basis, in claim 1, for this limitation, with respect to the substituted piperazines of the formula I. According to claim 1, neither R5, nor R6 and R7, is recited as S(O)2CH3, CO2H (and salts and deprotonated forms), and/or CH2-(4,4-difluoropiperidin-1-yl), respectively, with regard to the substituted piperazines of the formula I.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
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