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 1-21, 24, 27 and 33-35 are pending in the instant invention. According to the Amendments to the Claims, filed May 15, 2024, claims 2-16, 18-21, 24, 27 and 33-35 were amended and claims 22, 23, 25, 26, 28-32 and 36 were cancelled.
Status of Priority
This invention is a Continuation (CON) of International Application No. PCT/EP2022/081866, filed November 15, 2022, which claims priority under 35 U.S.C. § 119(a-d) to EP 21208773.8, filed November 17, 2021.
Restrictions / Election of Species
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The inventor’s or joint inventor’s provisional election of the following, without traverse, in the reply filed on August 7, 2026, is acknowledged: a) Group I - claims 1-21, 24 and 27; and b) substituted heteroaryl of formula Ib - p. 67, Example 18, shown to the right below, and hereafter referred to as 3-[4-[[(3R)-1-ethyl-3-piperidyl]amino]-1-methyl-pyrazolo[3,4-d]pyridazin-7-yl]bicyclo[4.2.0]octa-1(6),2,4-trien-2-ol, where R1 = -OH; R1b = -H; R2 and R3, taken together with the carbon atoms to which they are attached, form a 1,2-cyclobutylene; and Z is Ring System A, shown to the left above, wherein A1 = -NRX1-, where RX1 = -CH3, A2 = N, A3 = CRZ1, where RZ1 = -H, and W = -N-ethylpiperidin-3-
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yl. Claims 1-21, 24 and 27 read on the elected species. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
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Similarly, the inventor or joint inventor should further note that, in accordance with MPEP § 803.02, the instant Markush claim has been examined, with respect to the elected species, and further to the extent necessary to determine patentability. In the instant case, the substituted heteroaryls of the formula Ib, where R1 = -OH; R1b = -H; R2 and R3, taken together with the carbon atoms to which they are attached, form a 1,2-cyclobutylene; and Z is Ring System A, shown to the left, wherein A1 = -NRX1-, where RX1 = -alkyl, A2 = N, A3 = CRZ1, where RZ1 = -H, and W = -N-ethylpiperidin-3-yl, respectively, which encompass the elected species, have been found to be free of the prior art.
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Accordingly, the inventor or joint inventor should further note that the examiner has expanded scope of the instant Markush claim to further encompass substituted heteroaryls of the formula Ib, where (a) R2 = -halo, CN, alkyl, haloalkyl, or O(haloalkyl); and R3 is H; or (b) R2 and R3, taken together with the carbon atoms to which they are attached, form a cycloalkylene or heterocyclylene comprising one oxygen heteroatom; and Z is Ring System A, shown to the left, wherein (c) A1 = -NRX1-, A2 = N, and A3 = CRZ1; or (d) A1 = -S-, A2 = CRY1, and A3 = CRZ1, respectively; however, the instant Markush claim now fails to be free of the prior art, since it is rejected herein below in the section entitled: Claim Rejections - 35 U.S.C. § 102.
Consequently, the inventor or joint inventor should further note that the instant Markush claim is hereby restricted to substituted heteroaryls of the formula Ib, where (a) R2 = -halo, CN, alkyl, haloalkyl, or O(haloalkyl); and R3 is H; or (b) R2 and R3, taken together with the carbon atoms to which they are attached, form a cycloalkylene or heterocyclylene comprising one oxygen
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heteroatom; and Z is Ring System A, shown to the left, wherein (c) A1 = -NRX1-, A2 = N, and A3 = CRZ1; or (d) A1 = -S-, A2 = CRY1, and A3 = CRZ1, respectively, particularly as stated in the section below entitled Claim Objections.
Likewise, the inventor or joint inventor should further note that scope of the instant Markush claim will not be extended to cover additional nonelected species and/or groups of patentably distinct species.
Next, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Moreover, the inventor or joint inventor should further note that claims 33-35 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 1-21, 24 and 27 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 include and/or 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 heteroaryls of the formula Ib.
The following title is suggested: SUBSTITUTED HETEROARYLS AS NLRP3 INHIBITORS.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a) and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
A compound of formula Ib:
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Ib
or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof,
wherein:
R1 is H, haloalkyl, OH, or O(alkyl);
R1b is H, halo, or alkyl;
R2 is halo, CN, alkyl, haloalkyl, or O(haloalkyl);
R3 is H; or
R2 and R3, taken together with the carbon atoms to which they are attached, form a cycloalkylene or heterocyclylene, wherein the heterocyclylene contains one oxygen heteroatom; and
Z is Ring System A:
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Ring System A
wherein:
(i) A1 is -NRX1-;
RX1 is H, alkyl, or cyclopropyl;
A2 is N;
A3 is CRZ1; and
RZ1 is H or alkyl; or
(ii) A1 is -S-;
A2 is CRY1;
RY1 is H or alkyl;
A3 is CRZ1; and
RZ1 is H or alkyl; and
W is cyclobutyl, cyclohexyl, 6-membered heterocyclyl, or 1,2,3,4,5,6,7,8,8a-octahydroindolizin-7-yl;
wherein the 6-membered heterocyclyl contains one nitrogen heteroatom;
wherein the cyclobutyl is substituted with one CH3 substituent and one OH substituent;
wherein the cyclohexyl is substituted with one OH substituent; and
wherein the 6-membered heterocyclyl is substituted with one or two substituents independently selected from the group consisting of halo, alkyl, and OH.
Appropriate correction is required. See MPEP § 2173.02.
Claim 2 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 according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
A1 is -NRX1-; and
RX1 is H or alkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), 35 U.S.C. § 112(d) and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein A1 is -S-.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), 35 U.S.C. § 112(d) and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
A1 is -S-; and
RY1 is H.
Appropriate correction is required. See MPEP § 2173.02.
Claim 5 is objected to because of the following informalities: for brevity, clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
A1 is -NRX1-;
RX1 is alkyl; and
RZ1 is H.
Appropriate correction is required. See MPEP § 2173.02.
Claim 6 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein R1 is H or OH.
Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein R1 is OH.
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 according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein R1b is H.
Appropriate correction is required. See MPEP § 2173.02.
Claim 9 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 according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
R2 is halo, haloalkyl, or O(haloalkyl); and
R3 is H; or
R2 and R3, taken together with the carbon atoms to which they are attached, form a cyclobutylene or heterocyclylene, wherein the heterocyclylene contains one oxygen heteroatom.
Appropriate correction is required. See MPEP § 2173.02.
Claim 10 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 according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein R2 and R3, taken together with the carbon atoms to which they are attached, form a cycloalkylene or heterocyclylene, wherein the heterocyclylene contains one oxygen heteroatom.
Appropriate correction is required. See MPEP § 2173.02.
Claim 11 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 according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein R2 and R3, taken together with the carbon atoms to which they are attached, form a cycloalkylene.
Appropriate correction is required. See MPEP § 2173.02.
Claim 12 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 according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein R2 and R3, taken together with the carbon atoms to which they are attached, form a cyclobutylene or 5-membered heterocyclylene, wherein the 5-membered heterocyclylene contains one oxygen heteroatom.
Appropriate correction is required. See MPEP § 2173.02.
Claim 13 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 according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein R2 and R3, taken together with the carbon atoms to which they are attached, form a cyclobutylene.
Appropriate correction is required. See MPEP § 2173.02.
Claim 14 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein W is cyclobutyl, cyclohexyl, or 6-membered heterocyclyl;
wherein the 6-membered heterocyclyl contains one nitrogen heteroatom;
wherein the cyclobutyl is substituted with one CH3 substituent and one OH substituent;
wherein the cyclohexyl is substituted with one OH substituent; and
wherein the 6-membered heterocyclyl is substituted with one or two substituents independently selected from the group consisting of alkyl and OH.
Appropriate correction is required. See MPEP § 2173.02.
Claim 15 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein W is ethylpiperidinyl or N-ethylpiperidin-3-ol.
Appropriate correction is required. See MPEP § 2173.02.
Claim 16 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein W is ethylpiperidinyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 17 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 according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
R1 is H or OH;
R2 is halo, haloalkyl, or O(haloalkyl);
R3 is H;
(i) A1 is -NRX1-; and
RX1 is H or alkyl; or
(ii) A1 is -S-;
RY1 is H; and
W is cyclobutyl, cyclohexyl, or 6-membered heterocyclyl;
wherein the 6-membered heterocyclyl contains one nitrogen heteroatom;
wherein the cyclobutyl is substituted with one CH3 substituent and one OH substituent;
wherein the cyclohexyl is substituted with one OH substituent; and
wherein the 6-membered heterocyclyl is substituted with one or two substituents independently selected from the group consisting of alkyl, and OH.
Appropriate correction is required. See MPEP § 2173.02.
Claim 18 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 according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
R1 is H or OH;
R2 and R3, taken together with the carbon atoms to which they are attached, form a cyclobutylene or 5-membered heterocyclylene, wherein the 5-membered heterocyclylene contains one oxygen heteroatom; and
(i) A1 is -NRX1-; and
RX1 is H or alkyl; or
(ii) A1 is -S-;
RY1 is H; and
W is cyclobutyl, cyclohexyl, or 6-membered heterocyclyl;
wherein the 6-membered heterocyclyl contains one nitrogen heteroatom;
wherein the cyclobutyl is substituted with one CH3 substituent and one OH substituent;
wherein the cyclohexyl is substituted with one OH substituent; and
wherein the 6-membered heterocyclyl is substituted with one or two substituents independently selected from the group consisting of alkyl, and OH.
Appropriate correction is required. See MPEP § 2173.02.
Claim 19 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 according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
R1 is OH;
R1b is H;
R2 and R3, taken together with the carbon atoms to which they are attached, form a cyclobutylene or 5-membered heterocyclylene, wherein the 5-membered heterocyclylene contains one oxygen heteroatom; and
A1 is -NRX1-;
RX1 is alkyl;
RZ1 is H; and
W is ethylpiperidinyl or N-ethylpiperdin-3-ol.
Appropriate correction is required. See MPEP § 2173.02.
Claim 20 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 according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
R1 is OH;
R1b is H;
R2 and R3, taken together with the carbon atoms to which they are attached, form a cyclobutylene; and
A1 is -NRX1-;
RX1 is alkyl;
RZ1 is H; and
W is ethylpiperidinyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 21 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound according to claim 1, wherein the compound, or stereoisomer thereof, is selected from the group consisting of:
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or a pharmaceutically acceptable salt or tautomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 24 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a stereoisomer thereof, wherein the compound, or stereoisomer thereof, is:
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or a pharmaceutically acceptable salt or tautomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 27 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a compound according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof.
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.
Claim 4 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 4 recites the limitation, A compound according to claim 1, wherein Ring System A comprises 2 N heteroatoms, in lines 1-2 of the claim.
Similarly, the inventor or joint inventor should further note that MPEP § 2111.03 states the transitional term, comprising, which is synonymous with including, containing, or characterized by, is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. {See Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004); Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948); and Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005)}.
Moreover, the inventor or joint inventor should further note that [A] Markush group must be definite and complete as to its membership. A Markush group is indefinite, and claims are rejected, where the Markush group is defined as comprising. {See Ex parte Morrell, 100 USPQ 317 (Bd. Pat. App. & Int. 1953)}.
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 1-4, 6-9, 14, 17, 18 and 27 are rejected under 35 U.S.C. § 102(a)(2) as being anticipated by Collins, et al. in US 2024/0327413.
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The inventor or joint inventor should note that the instant invention recites a substituted heteroaryl of the formula Ib, shown to the left, where R1 = -OH; R1b = -H; R2 = -haloalkyl; R3 = -H; and Z is Ring System A, shown to the right above, wherein A1 = -S-, A2 = CRY1, where RY1 = -H, A3 = CRZ1, where RZ1 = -H, and W = -6-membered heterocyclyl, wherein the 6-membered heterocyclyl comprises one nitrogen heteroatom and is substituted with one or two independently selected alkyl substituents, respectively, and/or a pharmaceutical composition thereof, as a NOD-like receptor (NLR) family, pyrin domain-containing protein 3 (NLRP3) inhibitor.
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Similarly, the inventor or joint inventor should further note that Collins, et al. (US 2024/0327413), teach a substituted heteroaryl of the formula Ib, shown to the right, where R1 = -OH; R1b = -H; R2 = -CF3; R3 = -H; and Z is Ring System A, shown to the left above, wherein A1 = -S-, A2 = CRY1, where RY1 = -H, A3 = CRZ1, where RZ1 = -H, and W = -N-methylpiperidin-3-yl, respectively, and/or a pharmaceutical composition thereof, as a NOD-like receptor (NLR) family, pyrin domain-containing protein 3 (NLRP3) modulator {p. 45, ¶[0498], third compound; 63/216446 (06-29-21) - p. 65, column 2, row 4; and pharmaceutical compositions – p. 10, ¶[0097]}.
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.
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 1-4, 6-18, 21 and 27 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 heteroaryls of the formula Ib is improper, since the substituted heteroaryls of the formula Ib, as recited in claims 1, 21 and 27, 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 heteroaryls of the formula Ib to recite substituted heteroaryls of the formula Ib, where (a) R2 = -halo, CN, alkyl, haloalkyl, or O(haloalkyl); and R3 is H; or (b) R2 and R3, taken together with the carbon atoms to which they are attached, form a cycloalkylene or heterocyclylene comprising one oxygen heteroatom; and Z is Ring System A, shown to the left, wherein (c) A1 = -NRX1-, A2 = N, and A3 = CRZ1; or (d) A1 = -S-, A2 = CRY1, and A3 = CRZ1, respectively, 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.
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/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
Prosecution Insights