DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1, 3-8, 10, 12, 14, 21-26, 29 and 36 are pending in the instant invention. According to the Amendments to the Claims, filed March 4, 2026, claims 1, 3-8, 10, 12, 14, 21-24, 29 and 36 were amended and claims 2, 9, 11, 13, 15-20, 27, 28, 30-35 and 37-40 were cancelled.
Status of Priority
This invention is a Continuation (CON) of International Application No. PCT/EP2021/065085, filed June 7, 2021, which claims priority under 35 U.S.C. § 119(a-d) to China International Application No. PCT/CN2020/094920, filed June 8, 2020.
Status of Restrictions / Election of Species
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The inventor’s or joint inventor’s affirmation of the following election, without traverse, in the reply filed on March 4, 2026, is acknowledged: a) Group I - claims 1, 3-8, 10, 12, 14, 21-25 and 29; and b) substituted imidazo[1,2-a]-pyrazine of formula (I-1) - pp. 67-69, Example 23.
Similarly, the inventor or joint inventor should further note that, in accordance with MPEP § 803.02, the instant Markush claim was examined, with respect to the elected species, and further to the extent necessary to determine patentability. In the instant case, the substituted imidazo[1,2-a]pyrazines of the formula (I), where R1 = -C1-C6 alkyl; and X = -S(NR6)(O)-, respectively, which encompass the elected species, were found to be free of the prior art.
Accordingly, the inventor or joint inventor should further note that the Examiner expanded scope of the instant Markush claim to further encompass substituted imidazo[1,2-a]pyrazines of the formula (I), where X = -a covalent bond-, -(CH2)qS(O)2-, -NR5S(O)2-, -SR6(O)(N)-, or -S(O)(NR6)-; and R1 and one occurrence of R2, taken together with the atoms to which they are attached, do not form an optionally substituted C3-C10 cycloalkyl or 3- to 14-membered heterocyclyl, respectively, particularly as stated in the section entitled Claim Objections in the Non-Final Rejection, mailed on December 5, 2025; however, the instant Markush claim failed to be free of the prior art, since it was rejected under Claim Rejections - 35 U.S.C. § 102 in the Non-Final Rejection, mailed on December 5, 2025.
Consequently, the inventor or joint inventor should further note that in the Non-Final Rejection, mailed on December 5, 2025, the instant Markush claim was restricted to substituted imidazo[1,2-a]pyrazines of the formula (I), where X = -a covalent bond-, -(CH2)qS(O)2-, -NR5S(O)2-, -SR6(O)(N)-, or -S(O)(NR6)-; and R1 and one occurrence of R2, taken together with the atoms to which they are attached, do not form an optionally substituted C3-C10 cycloalkyl or 3- to 14-membered heterocyclyl, respectively, particularly as stated in the section entitled Claim Objections in the Non-Final Rejection, mailed on December 5, 2025.
Likewise, the inventor or joint inventor should further note that the requirement was made FINAL in the Non-Final Rejection, mailed on December 5, 2025.
Next, the inventor or joint inventor should further note that this invention contains claims 12, 14, 26 and 36, drawn to nonelected inventions, without traverse, in the reply filed on March 4, 2026. A complete reply to the Final Rejection may include cancellation of nonelected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.02.
Then, the inventor or joint inventor should further note that the sections of U.S.C. Title 35 that formed the basis of prior rejections formulated, as well as any references supporting said rejections, that are not included with this Office action, may be found in the Non-Final Rejection, mailed on December 5, 2025.
Moreover, the inventor or joint inventor should further note that any rejections and/or objections of record not explicitly addressed herein below, are hereby withdrawn, in light of the inventor’s or joint inventor’s arguments and/or the Amendments to the Claims, filed March 4, 2026.
Thus, a second Office action and prosecution on the merits of claims 1, 3-8, 10, 21-25 and 29 is contained within.
Status of Claim Rejections - Improper Markush Grouping
The inventor’s or joint inventor’s arguments, on pages 24-25 of the Remarks, filed March 4, 2026, with regard to claims 2 and 19, respectively, have been fully considered, but will not be discussed further, since according to the Amendments to the Claims, filed March 4, 2026, claims 2 and 19 have been cancelled by the inventor or joint inventor.
The inventor’s or joint inventor’s arguments, on pages 24-25 of the Remarks, filed March 4, 2026, with regard to claims 1, 3-8, 10, 21-25 and 29, respectively, have been fully considered, but are not persuasive. Consequently, the rejection of claims 1, 3-8, 10, 21-25 and 29, made in the Non-Final Rejection, mailed on December 5, 2025, is hereby maintained for the reasons of record.
The inventor or joint inventor primarily argues that the substituted imidazo[1,2-a]pyrazines of the formula (I-1) share a single structural similarity. Similarly, the inventor or joint inventor further argues that the substituted imidazo[1,2-a]pyrazines of the formula (I-1) share a common use that flows from the single structural similarity.
In response to the inventor’s or joint inventor’s argument that (1) the substituted imidazo-[1,2-a]pyrazines of the formula (I-1) share a single structural similarity, and that (2) the substituted imidazo[1,2-a]pyrazines of the formula (I-1) share a common use that flows from the single structural similarity, the Examiner respectfully disagrees, since the inventor’s or joint inventor’s arguments presented herein appear inapposite to the reasons of record forming the basis for the instant rejection under Improper Markush Grouping.
Likewise, the inventor or joint inventor should further note that a Markush grouping may be rejected under the judicially-approved improper Markush grouping principles when the Markush claim contains an improper Markush grouping of alternatively useable members, where either: (1) the alternatively useable members of the Markush group do not share a single structural similarity, or (2) the alternatively useable members of the Markush group do not share a common use. {See the Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications (Supplementary Guidelines), 76 Fed. Reg. 7162 (February 9, 2011), particularly at 7166 (citing In re Harnisch, 631 F.2d 716, 721-22, 206 USPQ 300, 305 (CCPA 1980)}.
Next, the inventor or joint inventor should further note that, in accord with MPEP § 803.02, the Markush grouping consisting of substituted imidazo[1,2-a]pyrazines of the formula (I-1) is improper, since the substituted imidazo[1,2-a]pyrazines of the formula (I-1), as recited in claims 1, 25 and 29, respectively, do not consist of alternatively useable members that share a single structural similarity and a common use that flows from the single structural similarity. {See MPEP § 803.02; and MPEP § 2117}.
Then, the inventor or joint inventor should further note that, in accord with MPEP § 803.02, [I]f the Markush-type claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush-type claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.
In the instant case, in accord with MPEP § 803.02, the inventor or joint inventor should further note that in the Non-Final Rejection, mailed on December 5, 2025, the instant Markush claim was restricted to substituted imidazo[1,2-a]pyrazines of the formula (I), where X = -a covalent bond-, -(CH2)qS(O)2-, -NR5S(O)2-, -SR6(O)(N)-, or -S(O)(NR6)-; and R1 and one occurrence of R2, taken together with the atoms to which they are attached, do not form an optionally substituted C3-C10 cycloalkyl or 3- to 14-membered heterocyclyl, respectively.
Moreover, in accord with MPEP § 803.02, the inventor or joint inventor should further note that the rejection of the Markush claims under the judicially-approved principles that they contain an improper Markush grouping of alternatively useable members will be maintained until (1) the Markush claims are amended to recite alternatively useable members that share a single structural similarity and a common use that flows from the single structural similarity, or (2) the inventor or joint inventor presents convincing arguments illustrating why the alternatively useable members recited in the Markush claims share a single structural similarity and a common use. {See MPEP § 803.02 and MPEP § 2117}.
As a result of the Amendments to the Claims, filed March 4, 2026, and to clarify the record, the original rejection, made in the Non-Final Rejection, mailed on December 5, 2025, is amended below, in the section entitled New Claim Rejections - Improper Markush Grouping, to omit cancelled claims 2 and 19, respectively.
New 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) and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
A compound of formula (I-1):
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(I-1)
or a pharmaceutically acceptable salt or stereoisomer thereof,
wherein:
(i) R1 is H, halogen, CN, C1-C6 alkyl, C1-C6 haloalkyl, C1-C6 cyanoalkyl, C1-C6 alkylene-C(O)-N(C1-C6 alkyl)2, C1-C6 aminoalkyl, C1-C6 alkylene-NH-C1-C6 alkyl, C1-C6 alkylene-N(C1-C6 alkyl)2, C1-C6 alkylene-N+(C1-C6 alkyl)3, C1-C6 hydroxyalkyl, C1-C6 alkylene-O(C1-C6 aminoalkyl), C1-C6 alkylene-O(C1-C6 alkylene)-N(C1-C6 alkyl)2, C(O)NHC1-C6 alkyl, NH2, NHC1-C6 alkyl, N(C1-C6 alkyl)2, OH, O(C1-C6 alkyl), O(C1-C6 haloalkyl), O(C1-C6 aminoalkyl), (OCH2CH2)rNH2, or O(C1-C6 alkylene)-NHC(O)C1-C6 alkyl; and
r is 1, 2, 3, or 4; or
(ii) R1 is:
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,
wherein:
L1 is a covalent bond or C1-C6 alkylene;
A is a C3-C10 cycloalkyl, 3- to 14-membered heterocyclyl, C6-C14 aryl, or 5- to 14-membered heteroaryl;
R7 is H, halogen, CN, C1-C6 alkyl, C1-C6 haloalkyl, C1-C6 cyanoalkyl, C1-C6 aminoalkyl, C1-C6 alkylene-NHC1-C6 alkyl, C1-C6 alkylene-N(C1-C6 alkyl)2, C1-C6 hydroxyalkyl, C1-C6 alkylene-O(C1-C6 aminoalkyl), C(O)C1-C6 alkylene-N(C1-C6 alkyl)2, C(O)C1-C6 alkylene-N+(C1-C6 alkyl)3, C(O)-(3- to 14-membered heterocyclyl), NH2, OH, O(C1-C6 alkyl), O(C1-C6 haloalkyl), or =O, wherein the 3- to 14-membered heterocyclyl is optionally substituted with one, two, or three substituents independently selected from the group consisting of halogen, CN, C1-C6 alkyl, C1-C6 haloalkyl, C(O)-(3- to 14-membered heterocyclylene)-OH, NH2, OH, O(C1-C6 alkyl), and O(C1-C6 haloalkyl);
R8 is H, halogen, CN, C1-C6 alkyl, C1-C6 haloalkyl, C1-C6 cyanoalkyl, C1-C6 aminoalkyl, C1-C6 alkylene-NHC1-C6 alkyl, C1-C6 alkylene-N(C1-C6 alkyl)2, C1-C6 hydroxyalkyl, C1-C6 alkylene-O(C1-C6 aminoalkyl), C(O)C1-C6 alkylene-N(C1-C6 alkyl)2, C(O)C1-C6 alkylene-N+(C1-C6 alkyl)3, C(O)-(3- to 14-membered heterocyclyl), NH2, OH, O(C1-C6 alkyl), O(C1-C6 haloalkyl), or =O, wherein the 3- to 14-membered heterocyclyl is optionally substituted with one, two, or three substituents independently selected from the group consisting of halogen, CN, C1-C6 alkyl, C1-C6 haloalkyl, C(O)-(3- to 14-membered heterocyclylene)-OH, NH2, OH, O(C1-C6 alkyl), and O(C1-C6 haloalkyl); and
R9 is H, halogen, CN, C1-C6 alkyl, C1-C6 haloalkyl, C1-C6 cyanoalkyl, C1-C6 aminoalkyl, C1-C6 alkylene-NHC1-C6 alkyl, C1-C6 alkylene-N(C1-C6 alkyl)2, C1-C6 hydroxyalkyl, C1-C6 alkylene-O(C1-C6 aminoalkyl), C(O)C1-C6 alkylene-N(C1-C6 alkyl)2, C(O)C1-C6 alkylene-N+(C1-C6 alkyl)3, C(O)-(3- to 14-membered heterocyclyl), NH2, OH, O(C1-C6 alkyl), O(C1-C6 haloalkyl), or =O, wherein the 3- to 14-membered heterocyclyl is optionally substituted with one, two, or three substituents independently selected from the group consisting of halogen, CN, C1-C6 alkyl, C1-C6 haloalkyl, C(O)-(3- to 14-membered heterocyclylene)-OH, NH2, OH, O(C1-C6 alkyl), and O(C1-C6 haloalkyl);
X is a covalent bond, *-(CH2)qS(O)2-, *-NR5S(O)2-, -SR6(O)(N)-*, or -S(O)(NR6)-*, wherein the * is the point of attachment to R1 and the point of attachment to the remainder of formula (I) is S;
R5 is H or C1-C6 alkyl;
R6 is C1-C6 alkyl, C1-C6 aminoalkyl, or C1-C6 alkylene-NHC(O)-(3- to 14- membered heterocyclyl), wherein the 3- to 14-membered heterocyclyl is optionally substituted with one or two OH substituents;
q is 0 or 1;
R2 is H, halogen, C1-C6 alkyl, C1-C6 hydroxyalkyl, or C(O)NHC1-C6 alkyl;
R3A is H or halogen;
R3B is H or halogen; and
R3C is halogen, O(C1-C6 alkyl), O(C1-C6 haloalkyl), O(C1-C6 cyanoalkyl), O(C2-C6 alkynyl), or O(5- to 14-membered heteroaryl).
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for brevity, clarity, precision and to avoid issues under 35 U.S.C. § 112(b), 35 U.S.C. § 112(d) and/or Improper Markush Grouping, 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 or C1-C6 alkyl; and
R6 is C1-C6 alkyl, C1-C6 aminoalkyl, or C1-C6 alkylene-NHC(O)-(3- to 14- membered heterocyclylene)-OH.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for brevity, clarity, precision and to avoid issues under 35 U.S.C. § 112(b), 35 U.S.C. § 112(d) and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
The compound of claim 3, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:
R5 is H;
R6 is C1-C6 alkyl or C1-C6 alkylene-NHC(O)-(3- to 14- membered heterocyclylene)-OH; and
q is 0.
Appropriate correction is required. See MPEP § 2173.02.
Claim 5 is objected to because of the following informalities: for brevity, 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 R6 is CH3 or CH2CH2CH2-NHC(O)-(pyrrolidinylene)-OH.
Appropriate correction is required. See MPEP § 2173.02.
Claim 6 is objected to because of the following informalities: for brevity, 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:
(i) R1 is halogen, C1-C6 alkyl, C1-C6 alkylene-C(O)-N(C1-C6 alkyl)2, C1-C6 aminoalkyl, C1-C6 alkylene-N+(C1-C6 alkyl)3, C1-C6 hydroxyalkyl, C1-C6 alkylene-O(C1-C6 aminoalkyl), C1-C6 alkylene-O(C1-C6 alkylene)-N(C1-C6 alkyl)2, NH2, N(C1-C6 alkyl)2, OH, O(C1-C6 alkyl), O(C1-C6 aminoalkyl), (OCH2CH2)rNH2, or O(C1-C6 alkylene)-NHC(O)C1-C6 alkyl; and
r is 2 or 3; or
(ii) R1 is:
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,
wherein:
A is a C3-C10 cycloalkyl, 3- to 14-membered heterocyclyl, or 5- to 14-membered heteroaryl;
R7 is H, C1-C6 alkyl, C1-C6 aminoalkyl, C1-C6 alkylene-N(C1-C6 alkyl)2, C1-C6 alkylene-O(C1-C6 aminoalkyl), C(O)C1-C6 alkylene-N(C1-C6 alkyl)2, C(O)C1-C6 alkylene-N+(C1-C6 alkyl)3, C(O)-(3- to 14-membered heterocyclyl), NH2, or =O, wherein the 3- to 14-membered heterocyclyl is optionally substituted with one substituent selected from the group consisting of C(O)-(3- to 14-membered heterocyclylene)-OH, and OH;
R8 is H or =O; and
R9 is H.
Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for brevity, 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 6, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:
(i) R1 is C1-C6 alkyl, C1-C6 alkylene-O(C1-C6 aminoalkyl), NH2, or (OCH2CH2)rNH2; and
r is 3; or
(ii) R1 is:
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,
wherein:
L1 is a covalent bond;
A is a C3-C10 cycloalkyl or 3- to 14-membered heterocyclyl; and
R7 is C1-C6 aminoalkyl, C1-C6 alkylene-N(C1-C6 alkyl)2, C(O)-(3- to 14-membered heterocyclyl)-OH, NH2, or =O.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for brevity, 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 7, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:
(i) R1 is CH3, CH2CH2OCH2CH2NH2, NH2, or (OCH2CH2)rNH2; and
r is 3; or
(ii) R1 is:
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,
wherein:
A is cyclohexyl, pyrrolidinyl, imidazolidinyl, isothiazolidinyl, piperidinyl, or piperazinyl; and
R7 is CH2NH2, CH(NH2)CH2CH2CH3, CH2CH(NH2)CH2CH3, CH2CH2CH(NH2)CH3, CH2CH2CH2CH2NH2, CH2CH2N(CH3)2, C(O)-(pyrrolidinylene)-OH, NH2, or =O.
Appropriate correction is required. See MPEP § 2173.02.
Claim 10 is objected to because of the following informalities: 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 R2 is H, halogen, C1-C6 alkyl, or C(O)NHC1-C6 alkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 22 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), 35 U.S.C. § 112(d) and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
The compound of claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:
(i) R1 is halogen, C1-C6 alkyl, C1-C6 alkylene-C(O)-N(C1-C6 alkyl)2, C1-C6 aminoalkyl, C1-C6 alkylene-N+(C1-C6 alkyl)3, C1-C6 hydroxyalkyl, C1-C6 alkylene-O(C1-C6 aminoalkyl), C1-C6 alkylene-O(C1-C6 alkylene)-N(C1-C6 alkyl)2, NH2, N(C1-C6 alkyl)2, OH, O(C1-C6 alkyl), O(C1-C6 aminoalkyl), (OCH2CH2)rNH2, or O(C1-C6 alkylene)-NHC(O)C1-C6 alkyl; or
(ii) R1 is:
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,
wherein:
A is a C3-C10 cycloalkyl, 3- to 14-membered heterocyclyl, or 5- to 14-membered heteroaryl;
R7 is H, C1-C6 alkyl, C1-C6 aminoalkyl, C1-C6 alkylene-N(C1-C6 alkyl)2, C1-C6 alkylene-O(C1-C6 aminoalkyl), C(O)C1-C6 alkylene-N(C1-C6 alkyl)2, C(O)C1-C6 alkylene-N+(C1-C6 alkyl)3, C(O)-(3- to 14-membered heterocyclyl), NH2, or =O, wherein the 3- to 14-membered heterocyclyl is optionally substituted with one substituent selected from the group consisting of C(O)-(3- to 14-membered heterocyclylene)-OH and OH;
R8 is H or =O; and
R9 is H;
R6 is C1-C6 alkyl, C1-C6 aminoalkyl, or C1-C6 alkylene-NHC(O)-(3- to 14- membered heterocyclylene)-OH;
R2 is H, halogen, C1-C6 alkyl, C1-C6 hydroxyalkyl, or C(O)NHC1-C6 alkyl;
R3A is H or F;
R3B is H, F, or Cl; and
R3C is OCH3, OCHF2, or O(pyridinyl).
Appropriate correction is required. See MPEP § 2173.02.
Claim 23 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), 35 U.S.C. § 112(d) and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
The compound of claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:
(i) R1 is C1-C6 alkyl, C1-C6 alkylene-O(C1-C6 aminoalkyl), or (OCH2CH2)rNH2; and
r is 3; or
(ii) R1 is:
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,
wherein:
L1 is a covalent bond;
A is a C3-C10 cycloalkyl or 3- to 14-membered heterocyclyl;
R7 is C1-C6 aminoalkyl, C1-C6 alkylene-N(C1-C6 alkyl)2, C(O)-(3- to 14-membered heterocyclylene)-OH, NH2, or =O;
R8 is H or =O; and
R9 is H;
R5 is H;
R6 is C1-C6 alkyl or C1-C6 alkylene-NHC(O)-(3- to 14- membered heterocyclylene)-OH;
q is 0;
R2 is H, halogen, C1-C6 alkyl, or C(O)NHC1-C6 alkyl;
R3A is H or F;
R3B is H, F, or Cl; and
R3C is OCH3, OCHF2, or O(pyridinyl).
Appropriate correction is required. See MPEP § 2173.02.
Claim 24 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), 35 U.S.C. § 112(d) and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
The compound of claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:
(i) R1 is CH3, CH2CH2OCH2CH2NH2, NH2, or (OCH2CH2)rNH2; and
r is 3; or
(ii) R1 is:
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,
wherein:
L1 is a covalent bond;
A is cyclohexyl, pyrrolidinyl, imidazolidinyl, isothiazolidinyl, piperidinyl, or piperazinyl;
R7 is CH2NH2, CH(NH2)CH2CH2CH3, CH2CH(NH2)CH2CH3, CH2CH2CH(NH2)CH3, CH2CH2CH2CH2NH2, CH2CH2N(CH3)2, C(O)-(pyrrolidinylene)-OH, NH2, or =O;
R8 is H or =O; and
R9 is H;
R5 is H;
R6 is CH3 or CH2CH2CH2-NHC(O)-(pyrrolidinylene)-OH;
q is 0;
R2 is H, Cl, CH3, CH2CH3, or C(O)NHCH3;
R3A is H or F;
R3B is H, F, or Cl; and
R3C is OCH3, OCHF2, or O(pyridinyl).
Appropriate correction is required. See MPEP § 2173.02.
Claim 25 is objected to because of the following informalities: a) brevity, clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), The compound of claim 1, or a pharmaceutically acceptable salt thereof, wherein the compound of formula (I) is selected from the group consisting of the group consisting of: should be replaced with The compound of claim 1, or a stereoisomer thereof, wherein the compound, or stereoisomer thereof, is selected from the group consisting of: ; and b) for clarity and precision, , or a pharmaceutically acceptable salt thereof should be inserted before the period. Appropriate correction is required. See MPEP § 2173.02.
Claim 29 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:
A pharmaceutical composition comprising a therapeutically inert carrier and a compound of claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
New 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, 3-8, 10, 21-24 and 29 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 claim 1 recites the limitations, m is… and n is…. There is insufficient antecedent basis, in claim 1, for this limitation, with respect to the substituted imidazo[1,2-a]pyrazines of the formula (I-1). According to claim 1, neither m, nor n, is recited, with respect to the substituted imidazo[1,2-a]pyrazines of the formula (I-1).
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 New Claim Objections, to overcome this rejection.
Claim 21 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 21 recites the limitations, The compound of claim 1,… wherein… m is 1 and n is…. There is insufficient antecedent basis, in claim 1, for this limitation, with respect to the substituted imidazo[1,2-a]pyrazines of the formula (I-1). According to claim 1, neither m, nor n, is recited, with respect to the substituted imidazo[1,2-a]pyrazines of the formula (I-1).
The examiner suggests cancelling the claim, to overcome this rejection.
Claim 22 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 22 recites the limitations, The compound of claim 1,… wherein… m is 1 and n is…. There is insufficient antecedent basis, in claim 1, for this limitation, with respect to the substituted imidazo[1,2-a]pyrazines of the formula (I-1). According to claim 1, neither m, nor n, is recited, with respect to the substituted imidazo[1,2-a]pyrazines of the formula (I-1).
The examiner suggests amending the claim, particularly as stated in the section above entitled New Claim Objections, to overcome this rejection.
Claim 23 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 23 recites the limitations, The compound of claim 1,… wherein… m is 1 and n is…. There is insufficient antecedent basis, in claim 1, for this limitation, with respect to the substituted imidazo[1,2-a]pyrazines of the formula (I-1). According to claim 1, neither m, nor n, is recited, with respect to the substituted imidazo[1,2-a]pyrazines of the formula (I-1).
The examiner suggests amending the claim, particularly as stated in the section above entitled New Claim Objections, to overcome this rejection.
Claim 24 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 24 recites the limitations, The compound of claim 1,… wherein… m is 1 and n is…. There is insufficient antecedent basis, in claim 1, for this limitation, with respect to the substituted imidazo[1,2-a]pyrazines of the formula (I-1). According to claim 1, neither m, nor n, is recited, with respect to the substituted imidazo[1,2-a]pyrazines of the formula (I-1).
The examiner suggests amending the claim, particularly as stated in the section above entitled New Claim Objections, to overcome this rejection.
New 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, 10 and 29 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Wren, et al. in WO 10/069684.
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The inventor or joint inventor should note that the instant invention recites a substituted imidazo[1,2-a]pyrazine of the formula (I-1), shown to the left, where X = -a covalent bond-; R1 = -H; R2 = -H; R3A = -H; R3B = -H; and R3C = -halo-C1-C6 alkoxy, respectively, and/or a pharmaceutical composition thereof, as an antibiotic.
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Similarly, the inventor or joint inventor should further note that Wren, et al. (WO 10/069684) teaches a substituted imidazo[1,2-a]pyrazine of the formula (I-1), shown to the right, where X = -a covalent bond-; R1 = -H; R2 = -H; R3A = -H; R3B = -H; and R3C = -OCF3, respectively, and/or a pharmaceutical composition thereof, as a luciferase modulator, useful in the treatment of muscular dystrophy {p. 30, compound 10; and pharmaceutical compositions - p. 4, ¶[0014]}.
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 imidazo[1,2-a]pyrazines of the formula (I-1). 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.
New Claim Rejections - Improper Markush Grouping
A Markush claim recites a list of alternatively useable members. The listing of specified alternatives within a Markush claim is referred to as a Markush group or a Markush grouping. {see Abbott Labs v. Baxter Pharmaceutical Products, Inc., 334 F.3d 1274, 1280-81, 67 USPQ2d 1191, 1196-97 (Fed. Cir. 2003). The claim language defined by a Markush grouping requires selection from a closed group consisting of the alternatively useable members (Id. at 1280, 67 USPQ2d at 1196). {See MPEP § 2111.03, subsection II, for a discussion of consisting of in the context of Markush groupings}.
A Markush grouping may be rejected under the judicially-approved improper Markush grouping principles when the Markush claim contains an improper Markush grouping of alternatively useable members, where either: (1) the alternatively useable members of the Markush group do not share a single structural similarity, or (2) the alternatively useable members of the Markush group do not share a common use. {See the Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications (Supplementary Guidelines), 76 Fed. Reg. 7162 (February 9, 2011), particularly at 7166 (citing In re Harnisch, 631 F.2d 716, 721-22, 206 USPQ 300, 305 (CCPA 1980)}.
The inventor or joint inventor should note that claims 1, 3-8, 10, 21-25 and 29 are rejected on the judicially-approved principles that they contain an improper Markush grouping of alternatively useable members. {See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980); and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984)}.
Similarly, the inventor or joint inventor should further note that a Markush grouping is proper if: (1) the alternatively useable members of the Markush group (i.e. alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a single structural similarity and belong to the same recognized physical or chemical class or to the same art-recognized class, and (2) the alternatively useable members of the Markush group (i.e. alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a common use and are disclosed in the specification or known in the art to be functionally equivalent. {See Supplementary Guidelines at 7166 and MPEP § 2117; and see MPEP § 2111.03 and MPEP § 2173.05(h) for discussions of when a Markush grouping may be indefinite under 35 U.S.C. § 112(b)}.
Likewise, the inventor or joint inventor should further note that the Markush grouping consisting of substituted imidazo[1,2-a]pyrazines of the formula (I) is improper, since the substituted imidazo[1,2-a]pyrazines of the formula (I), as recited in claims 1, 25 and 29, respectively, do not consist of alternatively useable members that share a single structural similarity and a common use that flows from the single structural similarity. {See MPEP § 803.02; and MPEP § 2117}.
Next, the inventor or joint inventor should further note that the rejection of the Markush claims under the judicially-approved principles that they contain an improper Markush grouping of alternatively useable members will be maintained until (1) the Markush claims are amended to recite alternatively useable members that share a single structural similarity and a common use that flows from the single structural similarity, or (2) the inventor or joint inventor presents convincing arguments illustrating why the alternatively useable members recited in the Markush claims share a single structural similarity and a common use. {See MPEP § 803.02 and MPEP § 2117}.
Moreover, the inventor or joint inventor should further note that this is a rejection on the merits and may be appealed to the Patent Trial and Appeal Board in accordance with 35 U.S.C. § 134 and 37 CFR 41.31(a)(1).
In accordance with the principles of compact prosecution, MPEP § 803.02, and MPEP § 2117, respectively, the examiner suggests the inventor or joint inventor amend the scope of the substituted imidazo[1,2-a]pyrazines of the formula (I) to recite substituted imidazo[1,2-a]-pyrazines of the formula (I), where X = -a covalent bond-, -(CH2)qS(O)2-, -NR5S(O)2-, -SR6(O)(N)-, or -S(O)(NR6)-; and R1 and one occurrence of R2, taken together with the atoms to which they are attached, do not form an optionally substituted C3-C10 cycloalkyl or 3- to 14-membered heterocyclyl, respectively, particularly as stated in the section above entitled New Claim Objections, to overcome this rejection.
Allowable Subject Matter
No claims are allowed.
Conclusion
The inventor’s or joint inventor’s arguments and/or the Amendments to the Claims, filed March 4, 2026, necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). The inventor or joint inventor is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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