DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-4, 7, 9, 11-18 and 37-50 are pending in the instant invention. According to the In The Claims, filed January 2, 2026, claims 1, 7, 9, 11-17 and 37 were amended, claims 5, 6, 8, 10 and 19-36 were cancelled and claims 39-50 were added.
Status of Priority
This invention claims priority under 35 U.S.C. § 119(e) to US Provisional Application No. 63/353,104, filed June 17, 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. 63/353,104, 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 R4, and is no longer coextensive with that of US Provisional Application No. 63/353,104.
Consequently, since the specification of US Provisional Application No. 63/353,104 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 the instant invention, filed June 16, 2023.
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 January 2, 2026, is acknowledged: a) Group I - claims 1-4, 7, 9, 11-18 and 37-50; and b) substituted 2,7-naphthyridine of formula (I) - pp. 870-871, Example 525, shown to the right below, and hereafter referred to as (1S,2R)-2-methyl-N-(8-(methylamino)-5-(6-morpholino-[1,2,4]triazolo[1,5-a]pyridin-2-yl)-2,7-naphthyridin-3-yl)cyclopropane-1-carboxamide, where R1 = -CH3; Y = -NH-; X = CH; R4 = -H; L = -a single bond-; R2 = -[1,2,4]triazolo[1,5-a]pyridin-2-yl, substituted at C-6, with morpholin-4-yl; and R3 = -NHC(O)-(2-methylcyclopropyl). Claims 1-4, 7, 13, 18, 37-46 and 48-50 read on the elected species. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
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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 2,7-naphthyridines of the formula (I), where R1 = -alkyl; Y = -NH-; X = CH; R4 = -H; L = -a single bond-; R2 = -substituted or unsubstituted [1,2,4]triazolo[1,5-a]pyridinyl; and R3 = -substituted or unsubstituted NHC(O)-cycloalkyl), respectively, which encompass the elected species, have been found to be free of the prior art.
Accordingly, the inventor or joint inventor should further note that the examiner has expanded scope of the instant Markush claim to further encompass substituted 2,7-naphthyridines of the formula (I), where Y = -NH-; X = CH; R4 = -H; L = -a single bond-; and R2 = -substituted or unsubstituted bicyclic heteroaryl, 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 2,7-naphthyridines of the formula (I), where Y = -NH-; X = CH; R4 = -H; L = -a single bond-; and R2 = -substituted or unsubstituted bicyclic heteroaryl, respectively.
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 9, 11 and 14-16 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 1-4, 7, 12, 13, 17, 18 and 37-50 is contained within.
Specification Objection - Disclosure
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the inventor’s or joint inventor’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility invention should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase Not Applicable should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR
DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A
COMPACT DISC.
(f) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art (including information disclosed under 37 CFR 1.97
and 1.98).
(g) BRIEF SUMMARY OF THE INVENTION.
(h) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(i) DETAILED DESCRIPTION OF THE INVENTION.
(j) CLAIM OR CLAIMS (commencing on a separate sheet).
(k) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(l) SEQUENCE LISTING (See MPEP § 2424 and 37 CFR 1.821-1.825).
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(b) above and 37 CFR 1.77(c). Revisions should particularly include and/or address: a) section headings (b-i), where applicable; and b) 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 2,7-naphthyridines of the formula (I).
The following title is suggested: SUBSTITUTED 2,7-NAPHTHYRIDINES AS TYK2 KINASE MODULATORS.
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) and/or Improper Markush Grouping, 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, stereoisomer, or tautomer thereof,
wherein:
X is CH;
R1 is H, alkyl, CD3, haloalkyl, cycloalkyl, halocycloalkyl, aryl, or heteroaryl;
Y is -NH-;
R4 is H;
L is a single bond;
R2 is a bicyclic heteroaryl, wherein the bicyclic heteroaryl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, CN, NO2, alkyl, alkyl(cycloalkyl), alkyl(heterocyclyl), alkyl(aryl), alkyl(heteroaryl), haloalkyl, haloalkyl(cycloalkyl), haloalkyl(heterocyclyl), haloalkyl(aryl), haloalkyl(heteroaryl), heteroalkyl, heteroalkyl(cycloalkyl), heteroalkyl(heterocyclyl), heteroalkyl(aryl), heteroalkyl(heteroaryl), alkenyl, alkenyl(cycloalkyl), alkenyl(heterocyclyl), alkenyl(aryl), alkenyl(heteroaryl), alkynyl, alkynyl(cycloalkyl), alkynyl(heterocyclyl), alkynyl(aryl), alkynyl(heteroaryl), C(O)H, C(O)alkyl, C(O)haloalkyl, C(O)alkenyl, C(O)alkynyl, C(O)cycloalkyl, C(O)heterocyclyl, C(O)aryl, C(O)heteroaryl, C(O)NH2, C(O)NH(alkyl), C(O)NH(haloalkyl), C(O)NH(alkenyl), C(O)NH(alkynyl), C(O)NH(cycloalkyl), C(O)NH(heterocyclyl), C(O)NH(aryl), C(O)NH(heteroaryl), C(O)N(alkyl)2, C(O)OH, C(O)O(alkyl), C(O)O(haloalkyl), C(O)O(alkenyl), C(O)O(alkynyl), C(O)O(cycloalkyl), C(O)O(heterocyclyl), C(O)O(aryl), C(O)O(heteroaryl), NH2, NH(alkyl), NH(haloalkyl), NH(alkenyl), NH(alkynyl), =NH, NH(cycloalkyl), NH(heterocyclyl), NH(aryl), NH(heteroaryl), =NH, NHC(O)alkyl, NHC(O)haloalkyl, NHC(O)alkenyl, NHC(O)alkynyl, NHC(O)cycloalkyl, NHC(O)heterocyclyl, NHC(O)aryl, NHC(O)heteroaryl, N(alkyl)2, N3, OH, O(alkyl), O(haloalkyl), O(alkenyl), O(alkynyl), =O, O(cycloalkyl), O(heterocyclyl), O(aryl), O(heteroaryl), SH, S(alkyl), S(haloalkyl), S(alkenyl), S(alkynyl), S(cycloalkyl), S(heterocyclyl), S(aryl), S(heteroaryl), S(O)alkyl, S(O)haloalkyl, S(O)alkenyl, S(O)alkynyl, S(O)NH2, S(O)cycloalkyl, S(O)heterocyclyl, S(O)aryl, S(O)heteroaryl, S(NH)(O)alkyl, S(NH)(O)haloalkyl, S(NH)(O)alkenyl, S(NH)(O)alkynyl, S(NH)(O)cycloalkyl, S(NH)(O)heterocyclyl, S(NH)(O)aryl, S(NH)(O)heteroaryl, S(O)2alkyl, S(O)2haloalkyl, S(O)2alkenyl, S(O)2alkynyl, S(O)2NH2, S(O)2cycloalkyl, S(O)2heterocyclyl, S(O)2aryl, S(O)2heteroaryl, S(O)2NH(alkyl), S(O)2NH(haloalkyl), S(O)2NH(alkenyl), S(O)2NH(alkynyl), S(O)2NH(cycloalkyl), S(O)2NH(heterocyclyl), S(O)2NH(aryl), S(O)2NH(heteroaryl), =S, cycloalkyl, cycloalkenyl, spirocycloalkyl, heterocyclyl, aryl, and heteroaryl; and
R3 is H, halo, NO2, CN, alkyl, haloalkyl, alkenyl, alkynyl, C(O)cycloalkyl, NH2, NH(alkyl), NHCH2CF3, NH(alkylaryl), NHC(O)alkyl, NHC(O)cycloalkyl, NH(cycloalkyl), NH(heterocycloalkyl), NH(aryl), NH(heteroaryl), O(alkyl), O(haloalkyl), O(cycloalkyl), or cycloalkyl, wherein the cycloalkyl of C(O)cycloalkyl, aryl of NH(alkylaryl), or cycloalkyl of NHC(O)cycloalkyl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, CN, NO2, alkyl, alkyl(cycloalkyl), alkyl(heterocyclyl), alkyl(aryl), alkyl(heteroaryl), haloalkyl, haloalkyl(cycloalkyl), haloalkyl(heterocyclyl), haloalkyl(aryl), haloalkyl(heteroaryl), heteroalkyl, heteroalkyl(cycloalkyl), heteroalkyl(heterocyclyl), heteroalkyl(aryl), heteroalkyl(heteroaryl), alkenyl, alkenyl(cycloalkyl), alkenyl(heterocyclyl), alkenyl(aryl), alkenyl(heteroaryl), alkynyl, alkynyl(cycloalkyl), alkynyl(heterocyclyl), alkynyl(aryl), alkynyl(heteroaryl), C(O)H, C(O)alkyl, C(O)haloalkyl, C(O)alkenyl, C(O)alkynyl, C(O)cycloalkyl, C(O)heterocyclyl, C(O)aryl, C(O)heteroaryl, C(O)NH2, C(O)NH(alkyl), C(O)NH(haloalkyl), C(O)NH(alkenyl), C(O)NH(alkynyl), C(O)NH(cycloalkyl), C(O)NH(heterocyclyl), C(O)NH(aryl), C(O)NH(heteroaryl), C(O)N(alkyl)2, C(O)OH, C(O)O(alkyl), C(O)O(haloalkyl), C(O)O(alkenyl), C(O)O(alkynyl), C(O)O(cycloalkyl), C(O)O(heterocyclyl), C(O)O(aryl), C(O)O(heteroaryl), NH2, NH(alkyl), NH(haloalkyl), NH(alkenyl), NH(alkynyl), =NH, NH(cycloalkyl), NH(heterocyclyl), NH(aryl), NH(heteroaryl), =NH, NHC(O)alkyl, NHC(O)haloalkyl, NHC(O)alkenyl, NHC(O)alkynyl, NHC(O)cycloalkyl, NHC(O)heterocyclyl, NHC(O)aryl, NHC(O)heteroaryl, N(alkyl)2, N3, OH, O(alkyl), O(haloalkyl), O(alkenyl), O(alkynyl), =O, O(cycloalkyl), O(heterocyclyl), O(aryl), O(heteroaryl), SH, S(alkyl), S(haloalkyl), S(alkenyl), S(alkynyl), S(cycloalkyl), S(heterocyclyl), S(aryl), S(heteroaryl), S(O)alkyl, S(O)haloalkyl, S(O)alkenyl, S(O)alkynyl, S(O)NH2, S(O)cycloalkyl, S(O)heterocyclyl, S(O)aryl, S(O)heteroaryl, S(NH)(O)alkyl, S(NH)(O)haloalkyl, S(NH)(O)alkenyl, S(NH)(O)alkynyl, S(NH)(O)cycloalkyl, S(NH)(O)heterocyclyl, S(NH)(O)aryl, S(NH)(O)heteroaryl, S(O)2alkyl, S(O)2haloalkyl, S(O)2alkenyl, S(O)2alkynyl, S(O)2NH2, S(O)2cycloalkyl, S(O)2heterocyclyl, S(O)2aryl, S(O)2heteroaryl, S(O)2NH(alkyl), S(O)2NH(haloalkyl), S(O)2NH(alkenyl), S(O)2NH(alkynyl), S(O)2NH(cycloalkyl), S(O)2NH(heterocyclyl), S(O)2NH(aryl), S(O)2NH(heteroaryl), =S, cycloalkyl, cycloalkenyl, spirocycloalkyl, heterocyclyl, aryl, and heteroaryl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein R1 is CH3 or CH2CH3.
Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
R3 is NHC(O)cyclopropyl-R3’; and
R3’ is H, halogen, CN, NO2, alkyl, haloalkyl, alkenyl, alkynyl, O(alkyl), O(haloalkyl), O(cycloalkyl), or spirocycloalkyl.
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 of claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
R2 is
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;
each X is independently CH or N;
Z is -O- or -S-;
each R5 is independently H, halogen, CN, alkyl, haloalkyl, C(O)alkyl, C(O)haloalkyl, C(O)cycloalkyl, C(O)heterocyclyl, C(O)aryl, C(O)heteroaryl, C(O)NH(alkyl), C(O)NH(haloalkyl), C(O)NH(cycloalkyl), C(O)NH(heterocyclyl), C(O)NH(aryl), C(O)NH(heteroaryl), NH(alkyl), NH(haloalkyl), NH(cycloalkyl), NH(heterocyclyl), NH(aryl), NH(heteroaryl), NHC(O)alkyl, NHC(O)haloalkyl, NHC(O)cycloalkyl, NHC(O)heterocyclyl, NHC(O)aryl, NHC(O)heteroaryl, OH, O(alkyl), O(haloalkyl), O(cycloalkyl), O(heterocyclyl), O(aryl), O(heteroaryl), S(alkyl), S(haloalkyl), S(cycloalkyl), S(heterocyclyl), S(aryl), S(heteroaryl), S(O)alkyl, S(O)haloalkyl, S(O)cycloalkyl, S(O)heterocyclyl, S(O)aryl, S(O)heteroaryl, S(O)2alkyl, S(O)2haloalkyl, S(NH)(O)alkyl, S(NH)(O)haloalkyl, S(NH)(O)cycloalkyl, S(NH)(O)heterocyclyl, S(NH)(O)aryl, S(NH)(O)heteroaryl, S(O)2cycloalkyl, S(O)2heterocyclyl, S(O)2aryl, S(O)2heteroaryl, S(O)2NH(alkyl), S(O)2NH(haloalkyl), S(O)2NH(cycloalkyl), S(O)2NH(heterocyclyl), S(O)2NH(aryl), S(O)2NH(heteroaryl), cycloalkyl, cycloalkenyl, heterocycloalkyl, fused bicyclic heterocyclyl, spirobicyclic heterocyclyl, aryl, and heteroaryl; and
n is 0, 1, 2, or 3.
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 of claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
R2 is
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each X is independently CH or N;
each R5 is independently H, halogen, CN, alkyl, haloalkyl, C(O)alkyl, C(O)haloalkyl, C(O)cycloalkyl, C(O)heterocyclyl, C(O)aryl, C(O)heteroaryl, C(O)NH(alkyl), C(O)NH(haloalkyl), C(O)NH(cycloalkyl), C(O)NH(heterocyclyl), C(O)NH(aryl), C(O)NH(heteroaryl), NH(alkyl), NH(haloalkyl), NH(cycloalkyl), NH(heterocyclyl), NH(aryl), NH(heteroaryl), NHC(O)alkyl, NHC(O)haloalkyl, NHC(O)cycloalkyl, NHC(O)heterocyclyl, NHC(O)aryl, NHC(O)heteroaryl, OH, O(alkyl), O(haloalkyl), O(cycloalkyl), O(heterocyclyl), O(aryl), O(heteroaryl), S(alkyl), S(haloalkyl), S(cycloalkyl), S(heterocyclyl), S(aryl), S(heteroaryl), S(O)alkyl, S(O)haloalkyl, S(O)cycloalkyl, S(O)heterocyclyl, S(O)aryl, S(O)heteroaryl, S(O)2alkyl, S(O)2haloalkyl, S(NH)(O)alkyl, S(NH)(O)haloalkyl, S(NH)(O)cycloalkyl, S(NH)(O)heterocyclyl, S(NH)(O)aryl, S(NH)(O)heteroaryl, S(O)2cycloalkyl, S(O)2heterocyclyl, S(O)2aryl, S(O)2heteroaryl, S(O)2NH(alkyl), S(O)2NH(haloalkyl), S(O)2NH(cycloalkyl), S(O)2NH(heterocyclyl), S(O)2NH(aryl), S(O)2NH(heteroaryl), cycloalkyl, cycloalkenyl, heterocycloalkyl, fused bicyclic heterocyclyl, spirobicyclic heterocyclyl, aryl, and heteroaryl; and
n is 0, 1, 2, or 3.
Appropriate correction is required. See MPEP § 2173.02.
Claim 17 is objected to because of the following informalities: a) for clarity and precision, The compound of claim 1, wherein the compound is selected from 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: ; b) for clarity and precision, appropriate punctuation (i.e. semicolon or comma) is required after each species; c) for clarity and precision, and should be inserted prior to the last species; d) for clarity, each claim must end with a period {see MPEP § 608.01(m); and Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995)}; and e) for clarity and precision, or a pharmaceutically acceptable salt or tautomer thereof should be inserted prior to the period. Appropriate correction is required. See MPEP § 2173.02.
Claim 18 is objected to because of the following informalities: a) for clarity and precision, The compound of claim 1, wherein the compound is selected from 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: ; b) for clarity and precision, appropriate punctuation (i.e. semicolon or comma) is required after each species; c) for clarity and precision, and should be inserted prior to the last species; d) for clarity, each claim must end with a period {see MPEP § 608.01(m); and Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995)}; and e) for clarity and precision, or a pharmaceutically acceptable salt or tautomer thereof should be inserted prior to the period. Appropriate correction is required. See MPEP § 2173.02.
Claim 37 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 pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a therapeutically effective amount of the compound of claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 40 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 13, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein R1 is CH3 or CH2CH3.
Appropriate correction is required. See MPEP § 2173.02.
Claim 42 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 13, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
R3 is NHC(O)cyclopropyl-R3’; and
R3’ is H, halogen, CN, NO2, alkyl, haloalkyl, alkenyl, alkynyl, O(alkyl), O(haloalkyl), O(cycloalkyl), or spirocycloalkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 43 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 13, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein each R5 is independently heterocycloalkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 44 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 13, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein each R5 is independently tetrahydrothiophenyl, piperidinyl, tetrahydropyranyl, piperazinyl, or morpholinyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 46 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound of claim 13, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein R2 is:
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.
Appropriate correction is required. See MPEP § 2173.02.
Claim 47 is objected to because of the following informalities: for clarity and precision, any claim may contain tables only if the subject matter of the claim makes the use of tables desirable; however, in the present instance, the use of a table is deemed undesirable. See MPEP § 11.10. Appropriate correction is required. See MPEP § 2173.02.
The examiner suggests omitting the table and reciting species, separated by appropriate punctuation (i.e. comma or semicolon). See 37 CFR 1.75(i).
Claim 47 is further objected to because of the following informalities: a) for clarity and precision, appropriate punctuation (i.e. semicolon or comma) is required after each species; b) for clarity and precision, and should be inserted prior to the last species; c) for clarity, each claim must end with a period {see MPEP § 608.01(m); and Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995)}; and d) for clarity and precision, or a pharmaceutically acceptable salt or tautomer thereof should be inserted prior to the period. Appropriate correction is required. See MPEP § 2173.02.
Claim 48 is objected to because of the following informalities: for clarity and precision, any claim may contain tables only if the subject matter of the claim makes the use of tables desirable; however, in the present instance, the use of a table is deemed undesirable. See MPEP § 11.10. Appropriate correction is required. See MPEP § 2173.02.
The examiner suggests omitting the table and reciting species, separated by appropriate punctuation (i.e. comma or semicolon). See 37 CFR 1.75(i).
Claim 48 is further objected to because of the following informalities: a) for clarity and precision, The compound of claim 1, wherein the compound is selected from 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: ; b) for clarity and precision, appropriate punctuation (i.e. semicolon or comma) is required after each species; c) for clarity and precision, and should be inserted prior to the last species; d) for clarity, each claim must end with a period {see MPEP § 608.01(m); and Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995)}; and e) for clarity and precision, or a pharmaceutically acceptable salt or tautomer thereof should be inserted prior to the period. Appropriate correction is required. See MPEP § 2173.02.
Claim 49 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 pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a therapeutically effective amount of the compound of claim 13, 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.
Claims 1-4, 7, 12, 13, 37-46, 49 and 50 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 1 recites the broad limitations, (1) alkyl, with regard to R1; (2) alkyl, with regard to R2; and (3) alkyl and NHaryl, with regard to R3, respectively, and the claim also recites (1) CH3, with regard to R1; (2) branched alkyl, with regard to R2; and (3) branched alkyl and NHphenyl, with regard to R3, respectively, which are the narrower statements of the limitations.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Next, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claims 1-4, 7, 12, 13, 37-46, 49 and 50 are further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, substituted, in claim 1, with regard to L, R2, and/or R3, respectively, is a relative term which renders the claim indefinite. The term, 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 134, uses open language, such as for example and without limitation, to define the term, substituent, using a boiler plate list of functional groups, such as fluorine, chlorine, 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 2,7-naphthyridines of the formula (I) have been rendered indefinite by the use of the term, substituted, with regard to L, R2, and/or R3, respectively.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claims 1-4, 12, 13, 37-41, 43-46, 49 and 50 are further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 1 recites the limitation, NHCHCF3, with respect to R3, where the limitation is implausible, resulting in an incomplete valence. Claims are unduly speculative where they define only a portion of a substituted 2,7-naphthyridine of the formula (I). Consequently, since incomplete valences are not permitted in the structure of the substituted 2,7-naphthyridines of the formula (I), an essential portion of the substituted 2,7-naphthyridines of the formula (I) is indefinite and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the substituted 2,7-naphthyridines of the formula (I). {See Ex parte Pedlow and Miner, 90 USPQ 395 (Bd. Pat. App. & Int. 1951)}.
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 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, 2, 4, 37 and 38 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Jonczyk, et al. in US 9,382,244.
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The inventor or joint inventor should note that the instant invention recites a substituted 2,7-naphthyridine of the formula (I), shown to the left, where R1 = -H; Y = -NH-; X = CH; R4 = -H; L = -a single bond-; R2 = substituted or unsubstituted bicyclic heteroaryl ring; and R3 = -H, respectively, and/or a pharmaceutical composition thereof, as a kinase modulator.
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Similarly, the inventor or joint inventor should further note that Jonczyk, et al. (US 9,382,244) teaches a substituted 2,7-naphthyridine of the formula (I), shown to the right, where R1 = -H; Y = -NH-; X = CH; R4 = -H; L = -a single bond-; R2 = -pyrrolo[2,3-b]pyridin-3-yl; and R3 = -H, respectively, and/or a pharmaceutical medicament thereof, as a TGF-b receptor kinase inhibitor [column 28, Table 2, Compound No. A32; and pharmaceutical medicaments - column 8, lines 45-49].
Likewise, the inventor or joint inventor should further note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Next, the inventor or joint inventor should further note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Then, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Moreover, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Furthermore, the inventor or joint inventor should also note that, although not explicitly discussed herein, this reference contains additional species that may anticipate the instantly recited substituted 2,7-naphthyridines of the formula (I). 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.
Also, 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, 7, 12, 13, 17, 18, 37-46, 49 and 50 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 2,7-naphthyridines of the formula (I) is improper, since the substituted 2,7-naphthyridines of the formula (I), as recited in claims 1, 17, 18 and 37, 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 2,7-naphthyridines of the formula (I) to recite substituted 2,7-naphthyridines of the formula (I), where Y = -NH-; X = CH; R4 = -H; L = -a single bond-; and R2 = -substituted or unsubstituted bicyclic heteroaryl, 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.
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