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 1-6, 9 and 14-18 are pending in the instant invention. According to the Amendments to the Claims, filed August 21, 2026, claim 9 was amended, claims 7, 8, and 10-13 were cancelled and claims 14-18 were added.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/KR2022/016188, filed October 21, 2022, which claims priority under 35 U.S.C. § 119(a-d) to: a) KR 10-2022-0014856, filed February 4, 2022; and b) KR 10-2021-0141877, filed October 22, 2021.
Restrictions / Election of Species
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The inventor’s or joint inventor’s provisional election of the following, without traverse, in the reply filed on August 21, 2026, is acknowledged: a) Group I - claims 1-6, 9 and 14-18; and b) substituted carboxamide of Chemical Formula 1 - p. 48, Table 2, compound 91, shown to the right below, and hereafter referred to as (S)-N-(5-(2-amino-[1,2,4]triazolo[1,5-a]pyridin-6-yl)-2-methylphenyl)-3-(4-cyanophenyl)isoxazolidine-2-carboxamide, where ring A1 = -[1,2,4]triazolo[1,5-a]pyridin-6-yl; m = 1; at C-2, R2 = -NH2; Z = CH; n = 1; R1 = -CH3; p = 0; ring A2 = -isoxazolidin-1-yl; R3 = -H; and ring A3 = -phenyl, substituted at C-4 with R4, wherein R4 = -CN. Claims 1-4, 6, 9, 14-16
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and 18 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 I, for a first Office action and prosecution on the merits.
Thus, a first Office action and prosecution on the merits of claims 1-6, 9 and 14-18 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 identifying: a) the substituted carboxamides of the Chemical Formula 1; and b) a particular utility for the substituted carboxamides of the Chemical Formula 1.
The following title is suggested: SUBSTITUTED CARBOXAMIDES AS INHIBITORS OF RIPK1 ACTIVITY.
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 Chemical Formula 1 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(a) and/or 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A compound of Chemical Formula 1:
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Chemical Formula 1
or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof,
wherein:
ring A1 is 5- to 12-membered heteroaryl;
each R2 is independently halogen, CN, C1-8 alkyl, C1-8 haloalkyl, C2-8 alkynyl, C(O)R5, C(O)NHR5, NH2, NHC1-8 alkyl, NHC(O)R5, N(C1-8 alkyl)2, or OC1-8 alkyl, wherein each C1-8 alkyl, C1-8 haloalkyl, C2-8 alkynyl, NH2, NHC1-8 alkyl, N(C1-8 alkyl)2, and OC1-8 alkyl is optionally and independently substituted with one OH substituent;
each R5 is independently C1-8 alkyl, C1-8 hydroxyalkyl, C1-8 alkylene-OC1-8 alkyl, or C3-8 cycloalkyl, wherein each C3-8 cycloalkyl is optionally and independently substituted with one substituent selected from the group consisting of halogen, NHC1-8 alkyl, and N(C1-8 alkyl)2;
m is 0, 1, 2, 3, or 4;
Z is CH or N;
each R1 is independently H, halogen, CN, C1-8 alkyl, OC1-8 alkyl, C3-8 cycloalkyl, or C3-8 heterocycloalkyl;
n is 1, 2, or 3;
ring A2 is 5- to 10-membered heterocycloalkyl, bicyclic 5- to 10-membered heterocycloalkyl-aryl, or bicyclic 5- to 10-membered heterocycloalkyl-heteroaryl;
p is 0, 1, or 2;
R3 is H or C1-8 alkyl;
ring A3 is 4- to 12-membered aryl or 4- to 12-membered heteroaryl, wherein the 4- to 12-membered aryl or 4- to 12-membered heteroaryl is optionally substituted with one or more independently selected R4 substituents; and
each R4 is independently halogen, CN, C1-8 alkyl, C1-8 haloalkyl, NHC1-8 alkyl, N(C1-8 alkyl)2, or OC1-8 alkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 2 is objected to because of the following informalities: for brevity, clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 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:
ring A1 is 8- to 10-membered heteroaryl, wherein the 8- to 10-membered heteroaryl contains at least one heteroatom selected from the group consisting of N, O, and S;
each R2 is independently halogen, CN, C1-6 alkyl, C1-6 haloalkyl, C2-6 alkynyl, C(O)R5, C(O)NHR5, NH2, NHC1-8 alkyl, NHC(O)R5, N(C1-8 alkyl)2, or OC1-6 alkyl, wherein each C1-6 alkyl, C1-6 haloalkyl, C2-6 alkynyl, NH2, NHC1-8 alkyl, N(C1-8 alkyl)2, and OC1-6 alkyl is optionally and independently substituted with one OH substituent;
each R5 is independently C1-6 alkyl, C1-6 hydroxyalkyl, C1-6 alkylene-OC1-6 alkyl, or C3-6 cycloalkyl, wherein each C3-6 cycloalkyl is optionally and independently substituted with one substituent selected from the group consisting of halogen, NHC1-8 alkyl, and N(C1-8 alkyl)2;
each R1 is independently H, halogen, CN, C1-6 alkyl, OC1-6 alkyl, or C3-6 cycloalkyl;
ring A2 is 5- to 8-membered heterocycloalkyl or bicyclic 8- to 10-membered heterocycloalkyl-aryl;
R3 is H or C1-6 alkyl;
ring A3 is 5- to 10-membered aryl or 4- to 8-membered heteroaryl;
wherein the 4- to 8-membered heteroaryl contains at least one heteroatom selected from the group consisting of N, O, and S; and
wherein the 5- to 10-membered aryl or 4- to 8-membered heteroaryl is optionally substituted with one or more independently selected R4 substituents; and
each R4 is independently halogen, CN, C1-6 alkyl, C1-6 haloalkyl, NHC1-8 alkyl, N(C1-8 alkyl)2, or OC1-6 alkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 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 ring A1 is indazolyl, benzo[d]oxazolyl, benzo[d]thiazolyl, benzo[d][1,2,3]triazolyl, pyrrolo[2,1-f][1,2,4]triazinyl, pyrazolo[1,5-a]pyridinyl, imidazo[1,2-a]pyridinyl, imidazo[4,5-b]pyridinyl, imidazo[4,5-c]pyridinyl, triazolo[1,5-a]pyridinyl, thiazolo[5,4-b]pyridinyl, thiazolo[4,5-c]pyridinyl, imidazo[1,2-b]pyridazinyl, triazolo[4,3-b]pyridazinyl, or thieno[3,2-d]pyrimidinyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 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 ring A2 is isoxazolidinyl, morpholinyl, oxaazaspiro[2.4]heptanyl, or benzo[d]isoxazolidinyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 5 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 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:
(i) R2 is C(O)R5;
R5 is C3-8 cycloalkyl, wherein the C3-8 cycloalkyl is optionally substituted with one halogen substituent; and
m is 1; or
(ii) R2 is C(O)NHR5;
R5 is C1-8 alkyl or C3-8 cycloalkyl, wherein the C3-8 cycloalkyl is optionally substituted with one NHC1-8 alkyl substituent or one N(C1-8 alkyl)2 substituent; and
m is 1; or
(iii) R2 is NHC(O)R5;
R5 is C1-8 alkyl, C1-8 hydroxyalkyl, C1-8 alkylene-OC1-8 alkyl, or C3-8 cycloalkyl, wherein the C3-8 cycloalkyl is optionally substituted with one halogen substituent; and
m is 1.
Appropriate correction is required. See MPEP § 2173.02.
Claim 6 is objected to because of the following informalities: a) for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), The compound of Chemical Formula 1, the isomer thereof, the solvate thereof, the hydrate thereof, or the pharmaceutically acceptable salt thereof of claim 1, wherein the compound represented by Chemical Formula 1 is any one of compounds 1 to 158 below: should be replaced with A compound selected from the group consisting of: ; b) for clarity and precision, where a claim sets forth a plurality of species, each species of the claim should be separated by a line indentation {see 37 CFR 1.75(i)}; and c) for clarity and precision, and <158>… . should be replaced with and <158>…, or a pharmaceutically acceptable salt or tautomer thereof. . Appropriate correction is required. See MPEP § 2173.02.
Claim 9 is objected to because of the following informalities: for brevity, clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
A pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and the compound of claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof.
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(a), 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 ring A3 is phenyl, naphthalenyl, furanyl, thiazolyl, pyrazolyl, or pyridinyl, wherein the phenyl, naphthalenyl, furanyl, thiazolyl, pyrazolyl, or pyridinyl is optionally substituted with one or more independently selected R4 substituents.
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(a), 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 each R4 is independently halogen, CN, CH3, CF3, N(CH3)2, or OCH3.
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(a), 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 each R1 is independently H, halogen, CN, C1-3 alkyl, OC1-3 alkyl, or C3-6 cycloalkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 17 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 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:
Z is N;
R1 is C1-8 alkyl or OC1-8 alkyl; and
n is 1.
Appropriate correction is required. See MPEP § 2173.02.
Claim 18 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 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 H or C1-3 alkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. § 112:
(a) IN GENERAL. The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Solvates and/or hydrates of substituted carboxamides of the Chemical Formula 1
Claims 1-6, 9 and 14-18 are rejected under 35 U.S.C. § 112(a) because the specification, while being enabling for substituted carboxamides of the Chemical Formula 1, does not reasonably provide enablement for solvates and/or hydrates of substituted carboxamides of the Chemical Formula 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. Solvates and/or hydrates of substituted carboxamides of the Chemical Formula 1, as recited in claims 1-6, 9 and 14-18, respectively, have not been adequately enabled in the specification to allow any person having ordinary skill in the art, at the time this invention was made, to make and/or use solvates and/or hydrates of substituted carboxamides of the Chemical Formula 1.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor or joint inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. {See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986); and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988)}.
The above factors, regarding the instant invention, are summarized as follows:
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(a) Breadth of the claims - the breadth of the claims includes substituted carboxamides of the Chemical Formula 1, shown to the right, as well as the myriad of potential solvates and/or hydrates formulated from these substituted carboxamides of the Chemical Formula 1, shown to the right, respectively;
(b) Nature of the invention - the nature of the invention is evaluation of substituted carboxamides of the Chemical Formula 1, shown to the right above, and/or solvates and/or hydrates thereof, and the pharmacokinetic behavior of these substances as inhibitors of receptor-interacting serine/threonine protein kinase 1 (RIPK1) activity;
(c) State of the prior art - Nature Reviews: Drug Discovery offers a snapshot of the state of the drug development art. Herein, drug development is stated to follow the widely accepted Ehrlich model which includes: (1) development of a broad synthetic organic chemistry program; (2) subsequent testing of compounds in an appropriate laboratory model for the disease to be treated; and (3) screening of compounds with low toxicity in prospective clinical trials (Jordan, V. C. Nature Reviews: Drug Discovery, 2, 2003, 205). Moreover, WO 23/068881 provides a synthesis of the instantly recited substituted carboxamides of the Chemical Formula 1 {Jo, et al. WO 23/068881, 2023};
(d) Level of one of ordinary skill in the art - the artisans synthesizing the inventor’s or joint inventor’s substituted carboxamides of the Chemical Formula 1, and/or solvates and/or hydrates thereof, would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience;
(e) Level of predictability in the art - Synthetic organic chemistry is quite unpredictable (See In re Marzocchi and Horton 169 USPQ at 367 ¶3). Similarly, it is unclear based on the combination of the instant specification, and Jo, et al. in WO 23/068881, whether the instantly recited solvates and/or hydrates of substituted carboxamides of the Chemical Formula 1 are enabled. Moreover, the following excerpt is taken from Vippagunta, et al., with respect to the synthesis of solvates and/or hydrates of substituted carboxamides of the Chemical Formula 1 (Vippagunta, et al. Advanced Drug Delivery Reviews, 48, 2001, 18):
Predicting the formation of solvates or hydrates of a compound and the number of molecules of water or solvent incorporated into the crystal lattice of a compound is complex and difficult. Each solid compound responds uniquely to the possible formation of solvates or hydrates and hence generalizations cannot be made for a series of related compounds. Certain molecular shapes and features favor the formation of crystals without solvent; these compounds tend to be stabilized by efficient packing of molecules in the crystal lattice, whereas other crystal forms are more stable in the presence of water and/or solvents. There may be too many possibilities so that no computer programs are currently available for predicting the crystal structures of hydrates and solvates.
(f) Amount of direction provided by the inventor - the invention lacks direction with respect to making and/or using solvates and/or hydrates of substituted carboxamides of the Chemical Formula 1;
(g) Existence of working examples - the inventor or joint inventor has provided sufficient guidance to make and/or use substituted carboxamides of the Chemical Formula 1; however, the disclosure is insufficient to allow extrapolation of the limited examples to enable the instantly recited solvates and/or hydrates of substituted carboxamides of the Chemical Formula 1. The specification lacks working examples of solvates and/or hydrates of substituted carboxamides of the Chemical Formula 1.
Within the specification, [A]t least one specific operative embodiment or example of the invention must be set forth. The example(s) and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula. See MPEP § 608.01(p) and MPEP § 2173.05.
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(h) Quantity of experimentation needed to make or use the invention based on the content of the disclosure - predicting whether a recited compound, and/or a solvate and/or hydrate thereof, is in fact one that produces a desired physiological effect at a therapeutic concentration and with useful kinetics, is filled with experimental uncertainty, and without proper guidance, would involve a substantial amount of experimentation (Jordan, V. C. Nature Reviews: Drug Discovery, 2, 2003, 205-213). Similarly, the specification, as originally filed, including any references incorporated therein, fails to provide the necessary support required by 35 U.S.C. § 112(a) to enable the instantly recited solvates and/or hydrates of substituted carboxamides of the Chemical Formula 1. Thus, it is unclear, based on the guidance provided by the specification, whether a hydrate of a substituted carboxamide of the Chemical Formula 1, such as (S)-N-(5-(2-amino-[1,2,4]triazolo[1,5-a]pyridin-6-yl)-2-methylphenyl)-3-(4-cyanophenyl)-isoxazolidine-2-carboxamide dihydrate, shown to the left above, is either synthetically feasible or possesses utility as an inhibitor of receptor-interacting serine/threonine protein kinase 1 (RIPK1) activity.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the invention was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. {See In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
The determination that undue experimentation would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. (See In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404). These factual considerations are discussed comprehensively in MPEP § 2164.08 (scope or breadth of the claims), § 2164.05(a) (nature of the invention and state of the prior art), § 2164.05(b) (level of one of ordinary skill), § 2164.03 (level of predictability in the art and amount of direction provided by the inventor or joint inventor), § 2164.02 (the existence of working examples) and § 2164.06 (quantity of experimentation needed to make or use the invention based on the content of the disclosure).
Based on a preponderance of the evidence presented herein, the conclusion that the inventor or joint inventor is insufficiently enabled for making and/or using solvates and/or hydrates of substituted carboxamides of the Chemical Formula 1, is clearly justified.
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. § 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 1-6, 9 and 14-18 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 term, isomer, in claims 1-6, 9 and 14-18, respectively, is a relative term which renders the claims indefinite. The term, isomer, is not defined by the claims, 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 12, uses open language, such as include and such as, to define the term, isomer, as tautomers and stereosiomers, but fails to specifically exclude constitutional isomers, which may be other than substituted carboxamides of the Chemical Formula 1. Moreover, neither the specification, nor the claims, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the substituted carboxamides of the Chemical Formula 1 have been rendered indefinite by the use of the term, isomer.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 4 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 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 4 recites the broad limitation, oxazinane, with regard to ring A2, and the claim also recites morpholine, with regard to ring A2, 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.
Claim 5 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 5 recites the limitation, The compound… of claim 1, wherein… when R2 is NHC(O)R5, R5 may be C3-8 cycloalkyl that is… substituted with C1-8 alkyl, C1-8 alkyl-C1-8 alkoxy, C1-8 alkylhydroxy, or halogen, in lines 1-8 of the claim. There is insufficient antecedent basis, in claim 1, for this limitation, with respect to the substituted carboxamides of the Chemical Formula 1. According to claim 1, R5 is not recited as C3-8 cycloalkyl that is… substituted with C1-8 alkyl, C1-8 alkyl-C1-8 alkoxy, and C1-8 alkylhydroxy, respectively, with regard to the substituted carboxamides of the Chemical Formula 1.
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.
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
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