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 1-16, 48 and 53-68 are pending in the instant invention. According to the Amendments to the Claims, filed May 8, 2023, claims 53 and 54 were amended and claims 17-47, 49-52 and 69 were cancelled.
Status of Priority
This invention claims priority under 35 U.S.C. § 119(e) to: a) US Provisional Application Nos.: a) 63/383,190, filed November 10, 2022; and b) 63/340,191, filed May 10, 2022.
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. 63/340,191, 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 amended definitions for at least R1, R2, R3, R4, R5, R6, R7, and/or Z, respectively, and is no longer coextensive with that of US Provisional Application No. 63/340,191.
Consequently, since the specification of US Provisional Application No. 63/340,191, 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 US Provisional Application No. 63/383,190, filed November 10, 2022.
Restrictions / Election of Species
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The inventor’s or joint inventor’s provisional election of the following, with traverse, in the reply filed on December 2, 2025, is acknowledged: a) Group I - claims 1-16, 48 and 53; and b) substituted pyrido[2,3-b][1,4]oxazine of formula I - pp. 128-131, Example 19, shown to the right below, and hereafter referred to as N-(5-fluoro-6-((methyl-sulfonyl)methyl)pyridin-3-yl)-7-(8-methyl-2,3-dihydro-1H-pyrido[2,3-b][1,4]oxazin-7-yl)-5,6,7,8-tetrahydropyrido[3,4-d]pyrimidin-2-amine, where R1 = -H; R2 = -H; R3 = -H; R4 = -CH3; R5 = -H; R6 = -H; R7 = -H; X = N; Y = N; W = CR8, wherein R8 = -(CH2)nS(O)2R10, where n = 1 and R10 = -CH3; Z = N; and R9 = -F. Claims 1-6, 8, 10, 11, 16, 48 and 53 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 since supposed errors in the restriction requirement were not distinctly and specifically pointed out, the election has been treated as an election, without traverse. See MPEP § 818.03(a).
Likewise, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Next, the inventor or joint inventor should further note that the elected species, shown to the right above, was found to be free of the prior art. Thus, the examiner has expanded the forthcoming prosecution to include all claims relevant to the genus of Group I, for a first Office action and prosecution on the merits.
Moreover, the inventor or joint inventor should further note that claims 54-68 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 1-16, 48 and 53 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 the substituted pyrido[2,3-b][1,4]oxazines of the formula I.
The following title is suggested: SUBSTITUTED PYRIDO[2,3-b][1,4]OXAZINES AS HPK1 INHIBITORS.
Appropriate correction is required.
Specification Objection - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, e.g., The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics. Exemplification of a species could be illustrative of members of the class. For processes, the reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating the structure of formula I into the abstract, to overcome this objection.
Claim Objections
Claim 1 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A compound of formula I:
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I
or a pharmaceutically acceptable salt or stereoisomer thereof,
wherein:
R1 is H, C1-C6 alkyl, C1-C6 haloalkyl, or C3-C6 cycloalkyl;
R2 is H, C1-C6 alkyl, C1-C6 haloalkyl, or C3-C6 cycloalkyl; or
R1 and R2, taken together with the carbon atom to which they are attached, form a C3-C6 carbocyclyl;
R3 is H or C1-C6 alkyl;
R4 is H, halogen, C1-C6 alkyl, C1-C6 haloalkyl, or C3-C6 cycloalkyl;
R5 is H, halogen, C1-C6 alkyl, C1-C6 haloalkyl, or C3-C6 cycloalkyl;
R6 is H, halogen, C1-C6 alkyl, C1-C6 haloalkyl, or C3-C6 cycloalkyl;
R7 is H or C1-C6 alkyl;
X is CH or N;
Y is CH or N;
W is CR8 or N;
Z is CH or N;
(i) R8 is H, halogen, C1-C6 alkyl, C1-C6 haloalkyl, (CH2)pC(O)R16, (CH2)mNR’R”, (CH2)nOR11, (CH2)nS(O)2R10, CR12R13S(O)2R10, C(O)-(CH2)pR16, C(O)-NR’-(CH2)oR15, NR’-(CH2)m-NR’R”, NR’-C(O)-(CH2)oR14, O-(CH2)n-OR11, OCH2S(O)2R10, C3-C6 cycloalkyl, C2-C8 heterocyclyl, C6-C14 aryl, or heteroaryl;
(ii) R8 is:
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;
(iii) R9 is H, halogen, C1-C6 alkyl, C1-C6 haloalkyl, (CH2)pC(O)R16, (CH2)mNR’R”, (CH2)nOR11, (CH2)nS(O)2R10, CR12R13S(O)2R10, C(O)-(CH2)pR16, C(O)-NR’-(CH2)oR15, NR’-(CH2)m-NR’R”, NR’-C(O)-(CH2)oR14, O-(CH2)n-OR11, OCH2S(O)2R10, C3-C6 cycloalkyl, C2-C8 heterocyclyl, C6-C14 aryl, or heteroaryl; or
(iv) R9 is:
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;
each R10 is independently C1-C6 alkyl, (CH2)mNR’R”, (CH2)pOR11, (CH2)n-O(CH2)n-OR11, or NR’R”;
each R11 is independently H, C1-C6 alkyl, C2-C8 heterocyclyl, C6-C14 aryl, or heteroaryl;
each R12 is independently H or C1-C6 alkyl;
each R13 is independently H or C1-C6 alkyl; or
R12 and R13, taken together with the carbon atom to which they are attached, form a C3-C6 carbocyclyl;
each R14 is independently H, C1-C6 alkyl, C2-C8 heterocyclyl, C6-C14 aryl, or heteroaryl;
each R15 is independently H, C1-C6 alkyl, C2-C8 heterocyclyl, C6-C14 aryl, or heteroaryl;
each R16 is independently H, C1-C6 alkyl, C2-C8 heterocyclyl, C6-C14 aryl, or heteroaryl;
each R’ is independently H, C1-C6 alkyl, or C3-C6 cycloalkyl;
each R” is independently H, C1-C6 alkyl, or C3-C6 cycloalkyl;
each m is independently 0, 1, 2, 3, 4, 5, or 6;
each n is independently 0, 1, 2, 3, 4, 5, or 6;
each o is independently 0, 1, 2, 3, 4, 5, or 6;
each p is independently 0, 1, 2, 3, 4, 5, or 6; and
each q is independently 0, 1, 2, 3, 4, 5, or 6;
wherein the C1-C6 alkyl of R8 and R9 is optionally substituted with one or more substituents independently selected from the group consisting of D, F, Cl, Br, I, CN, NO2, alkenyl, alkynyl, C(NH)NH(alkyl), C(NH)NH(alkenyl), C(NH)NH(alkynyl), C(NH)NH(carbocyclyl), C(NH)NH(heterocyclyl), C(NH)NH(aryl), C(NH)NH(heteroaryl), C(O)alkyl, C(O)alkenyl, C(O)alkynyl, C(O)carbocyclyl, C(O)heterocyclyl, C(O)aryl, C(O)heteroaryl, C(O)NH2, C(O)NH(alkyl), C(O)NH(alkenyl), C(O)NH(alkynyl), C(O)NH(carbocyclyl), C(O)NH(heterocyclyl), C(O)NH(aryl), C(O)NH(heteroaryl), NH2, NH(alkyl), NH(alkenyl), NH(alkynyl), NH(cycloalkyl), NH(heterocyclyl), NH(aryl), NH(heteroaryl), NHC(NH)alkyl, NHC(NH)alkenyl, NHC(NH)alkynyl, NHC(NH)carbocyclyl, NHC(NH)heterocyclyl, NHC(NH)aryl, NHC(NH)heteroaryl, NHC(NH)NH2, NHC(NH)NH(alkyl), NHC(NH)NH(alkenyl), NHC(NH)NH(alkynyl), NHC(NH)NH(carbocyclyl), NHC(NH)NH(heterocyclyl), NHC(NH)NH(aryl), NHC(NH)NH(heteroaryl), NHC(O)alkyl, NHC(O)alkenyl, NHC(O)alkynyl, NHC(O)carbocyclyl, NHC(O)heterocyclyl, NHC(O)aryl, NHC(O)heteroaryl, NHC(O)NH(alkyl), NHC(O)NH(alkenyl), NHC(O)NH(alkynyl), NHC(O)NH(carbocyclyl), NHC(O)NH(heterocyclyl), NHC(O)NH(aryl), NHC(O)NH(heteroaryl), NHC(O)O(alkyl), NHC(O)O(alkenyl), NHC(O)O(alkynyl), NHC(O)ONH2, NHC(O)O(carbocyclyl), NHC(O)O(heterocyclyl), NHC(O)O(aryl), NHC(O)O(heteroaryl), NHC(S)NH2, NHC(S)NH(alkyl), NHC(S)NH(alkenyl), NHC(S)NH(alkynyl), NHC(S)NH(carbocyclyl), NHC(S)NH(heterocyclyl), NHC(S)NH(aryl), NHC(S)NH(heteroaryl), NHS(O)2alkyl, NHS(O)2alkenyl, NHS(O)2alkynyl, NHS(O)2carbocyclyl, NHS(O)2heterocyclyl, NHS(O)2aryl, NHS(O)2heteroaryl, N(alkyl)2, N(aryl)2, N(heteroaryl)2, N3, OH, O(alkyl), O(haloalkyl), OCH2OCH3, OCH(OCH3)CH3, OCH2CH2OCH3, O(alkenyl), O(alkynyl), =O, O(cycloalkyl), O(heterocyclyl), O(aryl), O(heteroaryl), OC(O)NH(alkyl), OC(O)NH(alkenyl), OC(O)NH(alkynyl), OC(O)NH(carbocyclyl), OC(O)NH(heterocyclyl), OC(O)NH(aryl), OC(O)NH(heteroaryl), N(alkyl)2, N(aryl)2, N(heteroaryl)2, OC(O)O(alkyl), OC(O)O(alkenyl), OC(O)O(alkynyl), OC(O)ONH2, OC(O)O(carbocyclyl), OC(O)O(heterocyclyl), OC(O)O(aryl), OC(O)O(heteroaryl), SH, S(alkyl), S(alkenyl), S(alkynyl), =S, S(carbocyclyl), S(heterocyclyl), S(aryl), S(heteroaryl), S(NH)(O)alkyl, S(O)alkyl, S(O)alkenyl, S(O)alkynyl, S(O)carbocyclyl, S(O)heterocyclyl, S(O)aryl, S(O)heteroaryl, S(O)2alkyl, S(O)2alkenyl, S(O)2alkynyl, S(O)2carbocyclyl, S(O)2heterocyclyl, S(O)2aryl, S(O)2heteroaryl, S(O)2NH2, S(O)2NH(alkyl), S(O)2NH(alkenyl), S(O)2NH(alkynyl), S(O)2NH(carbocyclyl), S(O)2NH(heterocyclyl), S(O)2NH(aryl), S(O)2NH(heteroaryl), SiH2(alkyl), SiH(alkyl)2, Si(alkyl)3, cycloalkyl, carbocyclyl, heterocycloalkyl, heterocyclyl, aryl, and heteroaryl; and
wherein the C3-C6 cycloalkyl, C2-C8 heterocyclyl, C6-C14 aryl, or heteroaryl of R8 and R9 or each C3-C6 cycloalkyl, C2-C8 heterocyclyl, C6-C14 aryl, and heteroaryl of each R11 R14, R15, and R16 is optionally and independently substituted with one or more substituents independently selected from the group consisting of D, F, Cl, Br, I, CN, NO2, CH2NH2, CH2SCH3. CH2S(O)2CH3, CF3, alkyl, alkylO(alkyl), alkyl(aryl), alkyl(heteroaryl), alkenyl, alkynyl, C(NH)NH(alkyl), C(NH)NH(alkenyl), C(NH)NH(alkynyl), C(NH)NH(carbocyclyl), C(NH)NH(heterocyclyl), C(NH)NH(aryl), C(NH)NH(heteroaryl), C(O)alkyl, C(O)alkenyl, C(O)alkynyl, C(O)carbocyclyl, C(O)heterocyclyl, C(O)aryl, C(O)heteroaryl, C(O)NH2, C(O)NH(alkyl), C(O)NH(alkenyl), C(O)NH(alkynyl), C(O)NH(carbocyclyl), C(O)NH(heterocyclyl), C(O)NH(aryl), C(O)NH(heteroaryl), NH2, NH(alkyl), NH(alkenyl), NH(alkynyl), NH(cycloalkyl), NH(heterocyclyl), NH(aryl), NH(heteroaryl), NHC(NH)alkyl, NHC(NH)alkenyl, NHC(NH)alkynyl, NHC(NH)carbocyclyl, NHC(NH)heterocyclyl, NHC(NH)aryl, NHC(NH)heteroaryl, NHC(NH)NH2, NHC(NH)NH(alkyl), NHC(NH)NH(alkenyl), NHC(NH)NH(alkynyl), NHC(NH)NH(carbocyclyl), NHC(NH)NH(heterocyclyl), NHC(NH)NH(aryl), NHC(NH)NH(heteroaryl), NHC(O)alkyl, NHC(O)alkenyl, NHC(O)alkynyl, NHC(O)carbocyclyl, NHC(O)heterocyclyl, NHC(O)aryl, NHC(O)heteroaryl, NHC(O)NH(alkyl), NHC(O)NH(alkenyl), NHC(O)NH(alkynyl), NHC(O)NH(carbocyclyl), NHC(O)NH(heterocyclyl), NHC(O)NH(aryl), NHC(O)NH(heteroaryl), NHC(O)O(alkyl), NHC(O)O(alkenyl), NHC(O)O(alkynyl), NHC(O)ONH2, NHC(O)O(carbocyclyl), NHC(O)O(heterocyclyl), NHC(O)O(aryl), NHC(O)O(heteroaryl), NHC(S)NH2, NHC(S)NH(alkyl), NHC(S)NH(alkenyl), NHC(S)NH(alkynyl), NHC(S)NH(carbocyclyl), NHC(S)NH(heterocyclyl), NHC(S)NH(aryl), NHC(S)NH(heteroaryl), NHS(O)2alkyl, NHS(O)2alkenyl, NHS(O)2alkynyl, NHS(O)2carbocyclyl, NHS(O)2heterocyclyl, NHS(O)2aryl, NHS(O)2heteroaryl, N(alkyl)2, N(aryl)2, N(heteroaryl)2, N3, OH, O(alkyl), O(haloalkyl), OCH2OCH3, OCH(OCH3)CH3, OCH2CH2OCH3, O(alkenyl), O(alkynyl), =O, O(cycloalkyl), O(heterocyclyl), O(aryl), O(heteroaryl), OC(O)NH(alkyl), OC(O)NH(alkenyl), OC(O)NH(alkynyl), OC(O)NH(carbocyclyl), OC(O)NH(heterocyclyl), OC(O)NH(aryl), OC(O)NH(heteroaryl), N(alkyl)2, N(aryl)2, N(heteroaryl)2, OC(O)O(alkyl), OC(O)O(alkenyl), OC(O)O(alkynyl), OC(O)ONH2, OC(O)O(carbocyclyl), OC(O)O(heterocyclyl), OC(O)O(aryl), OC(O)O(heteroaryl), SH, S(alkyl), S(alkenyl), S(alkynyl), =S, S(carbocyclyl), S(heterocyclyl), S(aryl), S(heteroaryl), S(NH)(O)alkyl, S(O)alkyl, S(O)alkenyl, S(O)alkynyl, S(O)carbocyclyl, S(O)heterocyclyl, S(O)aryl, S(O)heteroaryl, S(O)2alkyl, S(O)2alkenyl, S(O)2alkynyl, S(O)2carbocyclyl, S(O)2heterocyclyl, S(O)2aryl, S(O)2heteroaryl, S(O)2NH2, S(O)2NH(alkyl), S(O)2NH(alkenyl), S(O)2NH(alkynyl), S(O)2NH(carbocyclyl), S(O)2NH(heterocyclyl), S(O)2NH(aryl), S(O)2NH(heteroaryl), SiH2(alkyl), SiH(alkyl)2, Si(alkyl)3, cycloalkyl, carbocyclyl, heterocycloalkyl, heterocyclyl, aryl, and heteroaryl.
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 according to claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:
R1 is H; and
R2 is H.
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 according to claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein R3 is 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 according to claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein R4 is H, Cl, CH3, CH2CH3, or cyclopropyl.
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 according to claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:
R5 is H; and
R6 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 or stereoisomer thereof, wherein R7 is H or CH3.
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 or stereoisomer thereof, wherein:
X is CH; and
Y is CH.
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 or stereoisomer thereof, wherein:
X is N; and
Y is N.
Appropriate correction is required. See MPEP § 2173.02.
Claim 9 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 or stereoisomer thereof, wherein:
X is N; and
Y is CH.
Appropriate correction is required. See MPEP § 2173.02.
Claim 10 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 or stereoisomer thereof, wherein W is CR8.
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 10, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:
(i) R8 is CH2S(NH)(O)CH3, CH2S(O)2CH3, CH2S(O)2CH2CH2N(CH3)2, CH2S(O)2CH2CH2OCH3, CH2S(O)2CH2CH2OCH2CH2OCH3, CH2S(O)2NH2, CH2S(O)2N(CH3)2, CH2S(O)2cyclopropyl, CH2CH2S(O)2CH3, (R)-CH(CH3)S(O)2CH3, (S)-CH(CH3)S(O)2CH3, C(CH3)2S(O)2CH3, OCH2S(O)2CH3, S(O)2CH3, S(O)2CH2CH2OCH2CH2OCH3, or 1-S(O)2CH3-cyclopropyl; or
(ii) R8 is:
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or
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;.
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 10, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein R8 is CH2NHCH3, CH2N(CH3)2, NHCH2CH2N(CH3)2, 4-hydroxypiperidin-1-yl, 4-methoxypiperidin-1-yl, 4-(trifluoromethoxy)piperidin-1-yl, 4-methylpiperidin-4-yl, 1-hydroxy-4-methylpiperidin-4-yl, 4-methylpiperazin-1-yl, or morpholin-4-yl.
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 10, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein R8 is CH2C(O)-(azetidin-1-yl), CH2C(O)-(3-fluoroazetidin-1-yl), CH2C(O)-(3-(methoxymethyl)azetidin-1-yl), CH2C(O)-(3-methoxyazetidin-1-yl), CH2C(O)-(3-isopropoxyazetidin-1-yl), CH2C(O)-(3-(morpholin-4-yl)azetidin-1-yl), CH2C(O)-(3,3-difluoroazetidin-1-yl), CH2C(O)-(3-hydroxy-3-methylazetidin-1-yl), CH2C(O)-(2-oxa-6-azaspiro[3.3]heptan-6-yl), C(O)-(3-(dimethylamino)azetidin-1-yl), C(O)NHCH3, C(O)NH-(3-methylazetidin-3-yl), C(O)NHCH2CH2-(morpholin-4-yl), C(O)-((R)-3-(dimethylamino)pyrrolidin-1-yl), NHC(O)CH3, NHC(O)-(1-methyloxetan-3-yl), NHC(O)CH2-(azetidin-1-yl), NHC(O)CH2-(pyrrolidin-1-yl), or NHC(O)CH2-(morpholin-4-yl),.
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 10, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein R8 is CH2CN, CH2OH, CH2CH2OH, C(CH3)2CN, C(CH3)2OH, OCH2CH2OCH3, or tetrahydropyran-4-yl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 15 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 10, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein R8 is CH2-pyrazol-1-yl, CH2-imidazol-1-yl, CH2-1,2,3-triazol-1-yl, CH2-1,2,3-triazol-2-yl, or CH2-1,2,4-triazol-1-yl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 16 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound according to claim 10, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein R9 is H, F, Cl, Br, I, CH3, CH2CN, CH2N(CH3)2, CH2OH, CH2S(O)2CH3, CH2-(morpholin-4-yl), CF3, CH2CH3, C(CH3)2OH, S(O)2CH3, tetrahydropyran-4-yl, 4-methylpiperazin-1-yl, or morpholin-4-yl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 48 is objected to because of the following informalities: a) for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), A compound according to claim 1 selected from the group consisting of: should be replaced with A compound selected from the group consisting of: ; and b) for clarity and precision, and pharmaceutically acceptable salts thereof should be replaced with or a pharmaceutically acceptable salt thereof. Appropriate correction is required. See MPEP § 2173.02.
Claim 53 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 adjuvant, carrier, or vehicle and a compound according to claim 1, or a pharmaceutically acceptable salt or stereoisomer 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.
Claims 1-16 and 53 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the phrase, optionally substituted, in claim 1, with regard to R8, R9, R11, R14, R15, and R16, respectively, is a relative phrase which renders the claim indefinite. The phrase, optionally substituted, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification, on page 60, uses open language, such as include, but are not limited to, to define the term, substituent, using a boiler plate list of functional groups, such as F, Cl, Br, I, etc., and further discloses that the substituents themselves may be further substituted; however, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the substituted pyrido[2,3-b][1,4]oxazines of the formula I have been rendered indefinite by the use of the phrase, optionally substituted, with regard to R8, R9, R11, R14, R15, and R16, 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 11 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 11 recites the limitation, The compound according to claim 10, wherein R8 is… CH2S(O)2CH2-(3-methyloxetan-3-yl), in lines 1-4 of the claim. There is insufficient antecedent basis, in claim 10, for this limitation, with respect to the substituted pyrido[2,3-b][1,4]oxazines of the formula I. According to claim 1, R8 is not recited as CH2S(O)2CH2-(3-methyloxetan-3-yl), with respect to the substituted pyrido[2,3-b][1,4]-oxazines of the formula I.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 12 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 12 recites the limitation, The compound according to claim 10, wherein R8 is… CH2-(4-hydroxy-4-methylazetidin-1-yl), CH2-pyrrrolidin-1-yl, CH2-piperidin-1-yl, CH2-(4-methylpiperazin-1-yl), CH2-(morpholin-4-yl), NHCH2CH2-(morpholin-4-yl), or N(CH3)CH2CH2-(morpholin-4-yl), in lines 1-5 of the claim. There is insufficient antecedent basis, in claim 10, for this limitation, with respect to the substituted pyrido[2,3-b][1,4]oxazines of the formula I. According to claim 1, R8 is not recited as either CH2-(4-hydroxy-4-methylazetidin-1-yl), CH2-pyrrrolidin-1-yl, CH2-piperidin-1-yl, CH2-(4-methylpiperazin-1-yl), CH2-(morpholin-4-yl), NHCH2CH2-(morpholin-4-yl), or N(CH3)CH2CH2-(morpholin-4-yl), respectively, with regard to the substituted pyrido[2,3-b][1,4]oxazines of the formula I.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 13 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 13 recites the limitation, The compound according to claim 10, wherein R8 is… CH2-(2-oxooxazolidin-3-yl), C(O)NHCH2CH2OCH3, NHC(O)CH2N(CH3)2, NHC(O)OCH3, or NHC(O)OCH2CH2OCH3, in lines 1-10 of the claim. There is insufficient antecedent basis, in claim 10, for this limitation, with respect to the substituted pyrido[2,3-b][1,4]oxazines of the formula I. According to claim 1, R8 is not recited as either CH2-(2-oxooxazolidin-3-yl), C(O)NHCH2CH2OCH3, NHC(O)CH2N(CH3)2, NHC(O)OCH3, or NHC(O)OCH2CH2OCH3, respectively, with regard to the substituted pyrido-[2,3-b][1,4]oxazines of the formula I.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 14 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 14 recites the limitation, The compound according to claim 10, wherein R8 is… OCH2-((R)-1,4-dioxan-2-yl), OCH2CH2-(morpholin-4-yl, or O-(tetrahydropyran-4-yl), in lines 1-5 of the claim. There is insufficient antecedent basis, in claim 10, for this limitation, with respect to the substituted pyrido[2,3-b][1,4]-oxazines of the formula I. According to claim 1, R8 is not recited as either OCH2-((R)-1,4-dioxan-2-yl), OCH2CH2-(morpholin-4-yl, or O-(tetrahydropyran-4-yl), respectively, with regard to the substituted pyrido[2,3-b][1,4]oxazines of the formula I.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 15 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 15 recites the limitation, The compound according to claim 10, wherein R8 is… 5-cyclopropyl-1,3,4-oxadiazol-2-yl, in lines 1-4 of the claim. There is insufficient antecedent basis, in claim 10, for this limitation, with respect to the substituted pyrido[2,3-b][1,4]oxazines of the formula I. According to claim 1, R8 is not recited as 5-cyclopropyl-1,3,4-oxadiazol-2-yl, with respect to the substituted pyrido[2,3-b][1,4]-oxazines of the formula I.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 16 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 15 recites the limitation, The compound according to claim 10, wherein R8 is… CH2-(4-methylpiperazin-1-yl), in lines 1-5 of the claim. There is insufficient antecedent basis, in claim 10, for this limitation, with respect to the substituted pyrido[2,3-b][1,4]oxazines of the formula I. According to claim 1, R8 is not recited as CH2-(4-methylpiperazin-1-yl), with respect to the substituted pyrido[2,3-b][1,4]oxazines 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.
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/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624