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 68-76, 84-86 and 92-131 are pending in the instant invention. According to the Amendments to the Claims, filed July 14, 2026, claims 1-67, 77-83 and 87-91 were cancelled.
Status of Priority
This invention is a Divisional (DIV) of US Application No. 17/718,381, filed April 12, 2022 and now US 12,037,346, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application Nos.: a) 63/292,605, filed December 22, 2021; b) 63/242,837, filed September 10, 2021; c) 63/239,089, filed August 31, 2011; and d) 63/174,177, filed April 13, 2021.
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 inventions (the provisional inventions). The disclosure of the invention in the prior-filed inventions 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 inventions, US Provisional Application Nos.: 63/292,605, 63/242,837, 63/239,089, and 63/174,177, respectively, fail 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-i), which now discloses amended definitions for at least R1, and is no longer coextensive with that of US Provisional Application Nos.: 63/292,605, 63/242,837, 63/239,089, and 63/174,177, respectively.
Consequently, since the specifications of US Provisional Application Nos.: 63/292,605, 63/242,837, 63/239,089, and 63/174,177, respectively, lack adequate support or enablement for one or more claims of the elected invention of Group III, 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 III will be prosecuted according to the earliest effective filing date afforded this invention, which is that of US Application No. 17/718,381, filed April 12, 2022.
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 July 14, 2026, is acknowledged: a) Group III - claims 68-76, 84-86 and 92-131; and b) substituted heteroaryl of Formula (I-i) - p. 271, Table 10, Example 62, shown to the right below, and hereafter referred to as (S)-1-(4-(8-((4-([1,2,4]triazolo-[1,5-a]pyridin-7-yloxy)-2-fluoro-3-(trifluoromethyl)phenyl)amino)pyrimido[5,4-d]pyrimidin-2-yl)-6-methyl-3,6-dihydropyridin-1(2H)-yl)prop-2-en-1-one, where m = 0; n = 1; p = 0; s = 1; t = 1; ring B = -[1,2,4]triazolo[1,5-a]pyridin-7-yl; J = -a bond-; R1 = -CH=CH2; R2 = -CH3; U = N; V = N; W = N; X1 = N; Y1 = CR4, wherein R4 = -F; and Y2 = CR4, wherein R4 = -
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CF3. Claims 68-76, 84-86, 92, 94, 96-104, 106-113 and 130 read on the elected species. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
Similarly, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Moreover, 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 III, for a first Office action and prosecution on the merits.
Thus, a first Office action and prosecution on the merits of claims 68-76, 84-86 and 92-131 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 heteroaryls of the Formula (I-i).
The following title is suggested: AMINO-SUBSTITUTED HETEROARYLS FOR TREATING CANCERS WITH EGFR MUTATIONS.
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-i) into the abstract, to overcome this objection.
Claim Objections
Claim 68 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A method for treating cancer in a mammal, wherein the method comprises administering to the mammal in need thereof a therapeutically effective amount of a compound of Formula (I-i):
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(I-i)
or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof,
wherein:
R1 is C1-5 alkyl, C2-5 alkenyl, C2-5 alkynyl, or 3- to 6-membered heterocyclyl, wherein the C1-5 alkyl, C2-5 alkenyl, C2-5 alkynyl, or 3- to 6-membered heterocyclyl is optionally substituted with one or more independently selected Ra substituents;
each Ra is independently halo, CN, C1-5 alkyl, C(O)OC1-5 alkyl, N(Rn1)2, OC1-5 alkyl, OC1-5 alkylene-OC1-5 alkyl, or 3- to 6-membered heterocyclyl, wherein each C1-5 alkyl, C(O)OC1-5 alkyl, OC1-5 alkyl, OC1-5 alkylene-OC1-5 alkyl, and 3- to 6-membered heterocyclyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl;
each Rn1 is independently H or C1-5 alkyl;
(i) J is -NRb-;
Rb is H or C1-5 alkyl, wherein the C1-5 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl; and
X1 is CH; or
(ii) J is a bond; and
X1 is N;
each R2 is independently C1-5 alkyl, wherein each C1-5 alkyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl; or
two geminal R2, taken together, form =O; or
two non-geminal R2, taken together, form a C1-4 alkylene bridge;
n is 0, 1, 2, or 3;
s is 0, 1, or 2;
t is 1 or 2;
U is CRc or N;
Rc is H, halo, or OC1-5 alkyl, wherein the OC1-5 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl;
V is CRd or N;
Rd is H, halo, C1-5 alkyl, or OC1-5 alkyl, wherein the C1-5 alkyl or OC1-5 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl;
W is CRe or N;
Re is H, halo, or CN;
Y1 is CH, CR4, or N;
Y2 is CH, CR4, or N;
each R4 is independently halo, C1-5 alkyl, or OC1-5 alkyl, wherein each C1-5 alkyl and OC1-5 alkyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl;
m is 0, 1, 2, 3, or 4;
ring B is 6- to 10-membered aryl or 5- to 10-membered heteroaryl;
each R5 is independently halo, C1-5 alkyl, or OC1-5 alkyl, wherein each C1-5 alkyl and OC1-5 alkyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(alkyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl;
p is 0, 1, 2, or 3;
each R36 is independently H or hydrocarbyl;
each R37 is independently H or hydrocarbyl; or
each R36 and R37, together with the nitrogen atom to which they are attached, independently forms a 4- to 8-membered heterocyclyl;
each R38 is independently hydrocarbyl;
each R39 is independently hydrocarbyl; and
each R40 is independently hydrocarbyl;
with the provisos that:
(1) at least one of U and V is N; and
(2) at least one of Y1 and Y2 is CH or CR4.
Appropriate correction is required. See MPEP § 2173.02.
Claim 69 is objected to because of the following informalities: for clarity, the claim is dependent upon an objected base claim. Appropriate correction is required.
Claim 70 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:
The method of claim 68, wherein:
(a) the cancer is associated with human epidermal growth factor receptor 2 (HER2) amplification; or
(b) the cancer is associated with at least one human epidermal growth factor receptor 2 (HER2) mutation; or
(c) the cancer is associated with human epidermal growth factor receptor 2 (HER2) overexpression; or
(d) the cancer is associated with human epidermal growth factor receptor 2 (HER2) amplification; and
the cancer is associated with at least one human epidermal growth factor receptor 2 (HER2) mutation; or
(e) the cancer is associated with human epidermal growth factor receptor 2 (HER2) amplification; and
the cancer is associated with human epidermal growth factor receptor 2 (HER2) overexpression; or
(f) the cancer is associated with at least one human epidermal growth factor receptor 2 (HER2) mutation; and
the cancer is associated with human epidermal growth factor receptor 2 (HER2) overexpression; or
(g) the cancer is associated with human epidermal growth factor receptor 2 (HER2) amplification;
the cancer is associated with at least one human epidermal growth factor receptor 2 (HER2) mutation;
the cancer is associated with human epidermal growth factor receptor 2 (HER2) overexpression.
Appropriate correction is required. See MPEP § 2173.02.
Claim 71 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 method of claim 70, wherein the cancer is associated with at least one human epidermal growth factor receptor 2 (HER2) exon 20 mutation.
Appropriate correction is required. See MPEP § 2173.02.
Claim 72 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:
The method of claim 68, wherein the cancer is selected from the group consisting of breast cancer, colorectal cancer, lung cancer, ovarian cancer, pancreatic cancer, prostate cancer, renal cancer, and squamous head and neck cancer.
Appropriate correction is required. See MPEP § 2173.02.
Claim 73 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 method of claim 72, wherein the lung cancer is non-small cell lung cancer.
Appropriate correction is required. See MPEP § 2173.02.
Claim 74 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 73, wherein the non-small cell lung cancer has at least one erythroblastic leukemia viral oncogene B (ErbB) mutation.
Appropriate correction is required. See MPEP § 2173.02.
Claim 75 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 73, wherein the non-small cell lung cancer has at least one epidermal growth factor receptor (EGFR) exon 20 insertion mutation.
Appropriate correction is required. See MPEP § 2173.02.
Claim 76 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 73, wherein the non-small cell lung cancer has at least one human epidermal growth factor receptor 2 (HER2) exon 20 insertion mutation.
Appropriate correction is required. See MPEP § 2173.02.
Claim 84 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 68, wherein the mammal is a human subject identified as having a human epidermal growth factor receptor 2 (HER2)-associated cancer or diagnosed as having a human epidermal growth factor receptor 2 (HER2)-associated cancer.
Appropriate correction is required. See MPEP § 2173.02.
Claim 85 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 68, wherein the method further comprises administering to the mammal in need thereof a therapeutically effective amount of a second therapeutic agent.
Appropriate correction is required. See MPEP § 2173.02.
Claim 86 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 85, wherein the second therapeutic agent is an immunomodulator or a platinum analog.
Appropriate correction is required. See MPEP § 2173.02.
Claim 92 is objected to because of the following informalities: for clarity, the claim is dependent upon an objected base claim. Appropriate correction is required.
Claim 93 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 68, wherein:
R1 is substituted with one or more independently selected Ra substituents; and
each Ra is independently F, Cl, CN, CH3, CH2N(CH3)2, CH2OCH3, CH2OCH2CH2OCH3, CH2-morpholino, CH2CH2N(CH3)2, C(O)OCH3, N(CH3)2, and pyrrolidinyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 94 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 68, wherein R1 is C2-5 alkenyl, wherein the C2-5 alkenyl is optionally substituted with one or more independently selected Ra substituents.
Appropriate correction is required. See MPEP § 2173.02.
Claim 95 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 68, wherein R1 is C2-5 alkynyl, wherein the C2-5 alkynyl is optionally substituted with one or more independently selected Ra substituents.
Appropriate correction is required. See MPEP § 2173.02.
Claim 96 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 68, wherein R1 is:
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or
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,
wherein:
Ra1 is H, halo, CN, C1-5 alkyl, CH2OC1-5 alkyl, CH2OCH2OC1-5 alkyl, CH2OCH2CH2OC1-5 alkyl, C(O)OC1-5 alkyl, NH2, NHC1-5 alkyl, N(C1-5 alkyl)2, or 3- to 6-membered heterocyclyl;
Ra2 is H, halo, CN, C1-5 alkyl, CH2OC1-5 alkyl, CH2OCH2OC1-5 alkyl, CH2OCH2CH2OC1-5 alkyl, C(O)OC1-5 alkyl, NH2, NHC1-5 alkyl, N(C1-5 alkyl)2, or 3- to 6-membered heterocyclyl;
Ra3 is H, halo, CN, C1-5 alkyl, CH2OC1-5 alkyl, CH2OCH2OC1-5 alkyl, CH2OCH2CH2OC1-5 alkyl, C(O)OC1-5 alkyl, NH2, NHC1-5 alkyl, N(C1-5 alkyl)2, or 3- to 6-membered heterocyclyl; and
Ra4 is H, halo, CN, C1-5 alkyl, CH2OC1-5 alkyl, CH2OCH2OC1-5 alkyl, CH2OCH2CH2OC1-5 alkyl, C(O)OC1-5 alkyl, NH2, NHC1-5 alkyl, N(C1-5 alkyl)2, or 3- to 6-membered heterocyclyl;
wherein each C1-5 alkyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl; and
wherein each C(O)OC1-5 alkyl and 3- to 6-membered heterocyclyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 97 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 68, wherein R1 is:
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or
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,
wherein:
Ra1 is H;
Ra2 is H;
Ra3 is H; and
Ra4 is H.
Appropriate correction is required. See MPEP § 2173.02.
Claims 98-111 are independently objected to because of the following informalities: for clarity, the claims are independently dependent upon an objected base claim. Appropriate correction is required.
Claim 112 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 110, wherein the compound is of Formula (I-i-a1):
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(I-i-a1)
or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof,
wherein:
Q1 is CRg or NRf;
Q2 is CRg or NRf;
Q3 is CRg or NRf;
Q4 is CRg or NRf;
each Rf is independently absent, H, or C1-5 alkyl, wherein each C1-5 alkyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl;
each Rg is independently absent, H, or C1-5 alkyl, wherein each C1-5 alkyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl;
R6 is H, halo, C1-5 alkyl, or OC1-5 alkyl, wherein the C1-5 alkyl or OC1-5 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl;
R7 is H, halo, C1-5 alkyl, or OC1-5 alkyl, wherein the C1-5 alkyl or OC1-5 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl;
R8 is H, halo, C1-5 alkyl, or OC1-5 alkyl, wherein the C1-5 alkyl or OC1-5 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl;
R9 is H, halo, C1-5 alkyl, or OC1-5 alkyl, wherein the C1-5 alkyl or OC1-5 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl;
R10 is H, halo, or C1-5 alkyl, wherein the C1-5 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl;
R11 is H or C1-5 alkyl, wherein the C1-5 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl;
R12 is H or C1-5 alkyl, wherein the C1-5 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl;
R13 is H or C1-5 alkyl, wherein the C1-5 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl; and
R14 is H or C1-5 alkyl, wherein the C1-5 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, aralkyl, C(NH)H, C(NH)hydrocarbyl, C(NH)NH2, C(NH)NH(hydrocarbyl), C(NH)N(hydrocarbyl)2, C(O)H, C(O)hydrocarbyl, C(O)NH2, C(O)NH(hydrocarbyl), C(O)N(hydrocarbyl)2, C(O)OH, C(O)O(hydrocarbyl), C(O)SR40, C(S)hydrocarbyl, C(S)OH, C(S)O(hydrocarbyl), NH2, NH(hydrocarbyl), N(hydrocarbyl)2, N3, OH, O(hydrocarbyl), OS(O)2OH, P(O)1-2hydrocarbyl, P(O)1-2OH, P(O)1-2O(hydrocarbyl), SH, S(hydrocarbyl), SC(O)R40, S(O)R38, S(O)2R39, S(O)2NR36R37, S(O)2OH, S(O)2O(hydrocarbyl), cycloalkyl, heterocyclyl, aryl, and heteroaryl;
with the provisos that:
(1) at least one of R11, R12, R13, and R14 is H; and
(2) at least one of Q1, Q2, Q3, and Q4 is CRg..
Appropriate correction is required. See MPEP § 2173.02.
Claims 113-131 are independently objected to because of the following informalities: for clarity, the claims are independently dependent upon an objected base claim. Appropriate correction is required.
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 70 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 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 70 recites the broad limitation, or, and the claim also recites and, which is the narrower statement of the limitation.
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.
Moreover, 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).
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claims 72-76 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 72 recites the broad limitation, lung cancer, and the claim also recites non-small cell lung cancer, which is the narrower statement of the limitation.
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.
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
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