DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application, filed 04/14/2023, is a 371 filing of PCT/US21/54921, filed 10/14/2021, which claims domestic priority to provisional U.S. application number 63/092,935 filed 10/16/2020.
Amendments and Claim Status
The amendment filed on 09/21/2023 is acknowledged and entered.
Claims 3-7, 12, 14, and 20-23 are amended;
Claims 8-11, 13, 15-19 are cancelled;
Claims 1-7, 12, 14, and 20-23 are pending in the instant application.
Information Disclosure Statement
The Information Disclosure Statement filed on 05/08/2023, 09/27/2024, 04/24/2025, and 07/25/2025 but are acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure statements are considered.
Restriction/Election
Applicant’s election with traverse of Group I in the reply filed on 10/27/2025 is acknowledged.
The traversal is on the grounds that Examiner has not provided a rationale as to why a person of ordinary skill in the art would have selected the prior art compound from among the hundreds of compounds disclosed by the prior art, as a starting point for modification.
This is not found persuasive because the claims lack unity of invention because the shared technical feature of the claims is not considered a special technical feature in light of the teachings detailed in the requirement for restriction office action, filed 08/27/2025. That is, there need not be a rationale as to why a person of ordinary skill in the art would have selected the prior art compound. The simple fact that the prior art compound exists and shares a common core structure with the compounds of the instant claims is enough to determine that the shared technical feature of the claims does not make a contribution over the prior art of record. Therefore, since this application is a national stage application and lacks unity of invention because the technical feature is not a special technical feature due to a lack of novelty, the restriction as set forth in the prior office action is proper.
The requirement is still deemed proper and is therefore made FINAL.
In accordance with the MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP § 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species (Figure 1) does not make a contribution over the prior art of record.
Figure 1. Elected Species
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Figure 1. Example 2, Applicant’s elected species
Status of Claims
Claims 1-7, 12, 14, and 20-23 are pending in the instant application. Claims 7 and 20-23 are withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 1-6, 12, and 14 read on the elected invention and species and are therefore under examination herein.
Claim Interpretation
The instant claims are subject to the following claim interpretation:
Claims 1-6, 12, and 14 are drawn to a phenyl, naphthyl, or heteroaryl group at position R6. According to the broadest reasonable interpretation of the claims set forth in MPEP § 2111, these are all aromatic substituents. With respect to a phenyl group, this is interpreted to be solely a phenyl group, i.e. an aromatic and fully unsaturated system of 6 carbon atoms. With respect to naphthyl, this is interpreted to be solely a naphthalene group, which is two fused benzene rings, i.e., an aromatic and fully unsaturated system of 10 carbon atoms. Finally, with respect to a heteroaryl group, the term heteroaryl is interpreted, according to the instant specification (page 12 lines 10-14), to be a monocyclic, bicyclic, or tricyclic aromatic ring system having 5-14 ring atoms, containing 1-4 heteroatoms selected from oxygen, nitrogen, and sulfur. As a general rule, well-known to a person of ordinary skill in the art, all carbon atoms within an aromatic system—including heteroaryl—must be sp2 hybridized in order to be considered aromatic. This is because sp3 hybridization eliminates the aromatic character within a ring system. Furthermore, aromatic systems are cyclic, planer, and conjugated. All atoms within the aromatic ring systems must have a p-orbital to allow π-electrons to delocalize over the entire structure. Finally, an aromatic system must contain (4𝑛+2) π-electrons, where 𝑛 denotes the number of electrons which may be any non-negative integer (e.g., 2, 6, 10, or 14 electrons).
Claim Rejections - 35 U.S.C. § 112 (b)
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. § 112, the applicant), regards as the invention.
Regarding claim 6, there are several compounds whose names are presently written incorrectly with respect to the rules of IUPAC nomenclature. In the current state-of-the-art, chemical structure programs use the rules of IUPAC nomenclature to create a two-dimensional structure from a given compound name. In the instant case, two separate programs were employed by the Examiner to convert the chemical names into two-dimensional structures, all three of which failed (1: Chemaxon, JChem for office; 2: OPSIN, https://www.ebi.ac.uk/opsin/). As such, the compound names included hereinafter are deemed to be indefinite, because a person of ordinary skill in the art would not be apprised to the exact chemical compound which is being claimed. It should be stated that it is always preferred for Applicant to include the two-dimensional structures within the claims, or a corresponding compound number within the specification which corresponds to the compounds—for example in a table— to make it absolutely clear to a person of ordinary skill in the art, without the burden of structure conversion on the part of the reader, the exact compound which is being claimed. Small mistakes in IUPAC nomenclature are common in the chemical arts, and can easily create confusion, indefiniteness, and errors within structure conversion programs.
For the sake of compact prosecution, Examiner hereinafter includes the names of the compounds which are deemed indefinite within the claim, and immediately after, the name to a suggested correction (if the name were to comply with proper IUPAC nomenclature rules). Examiner submits that it is entirely possible that the proposed corrected name included herein may not result in the compound intended to be claimed by Applicant. As such, Examiner yields to Applicant to completely define and delineate the compounds intended by applicant to be included in the claim. Particular attention should be paid to MPEP § 608.04, regarding new matter upon amendment.
6-(Azetidin-1-yl)-4-fluoro-N-(2-1{[-1,1,1-trifluoropropan-2-yl]oxy}benzene-1-sulfonyl)-1-benzofuran-2-carboxamide,
should be corrected to:
6-(Azetidin-1-yl)-4-fluoro-N-(2-1{[1,1,1-trifluoropropan-2-yl]oxy}benzenesulfonyl)-1-benzofuran-2-carboxamide,
1-{2-[(2-Ethoxybenzene-1-sulfonyl)carbamoyl]-4-fluoro-1-benzofuran-6-yl}azetidine-2-carboxamide,
should be corrected to:
1-{2-[(2-Ethoxyphenylsulfonyl)carbamoyl]-4-fluoro-1-benzofuran-6-yl}azetidine-2-carboxamide,
N-(4-Aacetamidonaphthalene-1-sulfonyl)-6-(azetidin-1-yl)-4-fluoro-1-benzofuran-2-carboxamide,
should be corrected to:
N-(4-acetamidonaphthalenesulfonyl)-6-(azetidin-1-yl)-4-fluoro-1-benzofuran-2-carboxamide,
6-(Azetidin-1-yl)-N-[(2-(benzyloxy)-5-(tert-butyl)phenyl]sulfonyl)-4-fluorobenzofuran-2-carboxamide,
should be corrected to:
6-(azetidin-1-yl)-N-((2-(benzyloxy)-5-(tert-butyl)phenyl)sulfonyl)-4-fluorobenzofuran-2-carboxamide,
Claim Rejections - 35 U.S.C. § 112 (d)
The following is a quotation of 35 U.S.C. § 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. § 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. § 112(d) or pre-AIA 35 U.S.C. § 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 6, the claim recites the limitation "dihydrobenzofuran" in position R6 within several chemical compound names recited within the claim. This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of R6 within claim 1, on which claim 6 is based. Specifically, R6 is defined as phenyl, naphthyl, nor heteroaryl group by claim 1. However, dihydrobenzofuran is defined as neither a phenyl, naphthyl, or heteroaryl group. For example, the IUPAC name 6-(Azetidin-1-yl)-N-(5-bromo-2,3-dihydro-1-benzofuran-7-sulfonyl)-4-fluoro-1-benzofuran-2-carboxamide
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defines a compound with dihydrobenzofuran
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at position R6, directly adjacent to the sulfonamide group of a compound of Formula (I),
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. According to the definition of heteroaryl found within the instant specification on page 12, lines 10-23, “heteroaryl” means a monocyclic, bicyclic or tricyclic aromatic ring system. The specification further defines heteroaryl to include benzofuranyl,
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, which exhibits aromaticity, in direct contrast to dihydrobenzofuranyl, which does not. This is because sp3 hybridization eliminates the aromatic character within an aromatic ring system. All carbon atoms within an aromatic ring system, including heteroaryl, must be sp2 hybridized in order to be aromatic. Dihydrobenzofuran is better defined as a heterocyclic substituent. In direct support of this argument, the definition of “heterocycloalkyl” found in the instant specification is defined as “4 to 10-membered heterocycloalkyl.. (that is a).. partially unsaturated.. bicycle.. that contains 1.. heteroatom selected from oxygen.” This definition of a heterocyclic system is directly descriptive of dihydrobenzofuran. A heterocyclic substituent at position R6 is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
Further regarding claim 6, the claim recites the limitation "dihydrobenzopyran" in position R6 within several chemical compound names recited within the claim. This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of R6 within claim 1, on which claim 6 is based. Specifically, R6 is defined as phenyl, naphthyl, nor heteroaryl group by claim 1. However, dihydrobenzopyran is defined as neither a phenyl, naphthyl, or heteroaryl group. For example, the IUPAC name 6-(Azetidin-1-yl)-N-(3,4-dihydro-2H-1-benzopyran-8-sulfonyl)-4-fluoro-1-benzofuran-2-carboxamide
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defines a compound with dihydrobenzopyran
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at position R6, directly adjacent to the sulfonamide group of a compound of Formula (I),
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. For all the reasons set forth above, dihydrobenzopyran is better defined as a heterocyclic substituent. In direct support of this argument, the definition of “heterocycloalkyl” found in the instant specification is defined as “4 to 10-membered heterocycloalkyl.. (that is a).. partially unsaturated.. bicycle.. that contains 1.. heteroatom selected from oxygen.” This definition of a heterocyclic system is directly descriptive of dihydrobenzopyran. A heterocyclic substituent at position R6 is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
Further regarding claim 6, the claim recites the limitation "tetrahydrobenzothiopyran" in position R6 within several chemical compound names recited within the claim. This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of R6 within claim 1, on which claim 6 is based. Specifically, R6 is defined as phenyl, naphthyl, nor heteroaryl group by claim 1. However, tetrahydrobenzothiopyran is defined as neither a phenyl, naphthyl, or heteroaryl group. For example, the 6-(Azetidin-1-yl)-N-(1,1-dioxo-1,2,3,4-tetrahydro-1-benzothiopyran-8-sulfonyl)-4-fluoro-1-benzofuran-2-carboxamide,
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, defines a compound with tetrahydrobenzothiopyran
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at position R6, directly adjacent to the sulfonamide group of a compound of Formula (I),
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. For all the reasons set forth above, tetrahydrobenzothiopyran is better defined as a heterocyclic substituent. In direct support of this argument, the definition of “heterocycloalkyl” found in the instant specification is defined as “4 to 10-membered heterocycloalkyl.. (that is a).. partially unsaturated.. bicycle.. that contains.. .. heteroatoms selected from oxygen and sulfur.” This definition of a heterocyclic system is directly descriptive of tetrahydrobenzothiopyran. A heterocyclic substituent at position R6 is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
Further regarding claim 6, the claim recites the limitation "dihydrobenzodioxine" in position R6 within several chemical compound names recited within the claim. This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of R6 within claim 1, on which claim 6 is based. Specifically, R6 is defined as phenyl, naphthyl, nor heteroaryl group by claim 1. However, dihydrobenzodioxine is defined as neither a phenyl, naphthyl, or heteroaryl group. For example, the 6-(Azetidin-1-yl)-N-(2,3-dihydro-1,4-benzodioxine-5-sulfonyl)-4-fluoro-1-benzofuran-2-carboxamide,
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defines a compound with dihydrobenzodioxine
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at position R6, directly adjacent to the sulfonamide group of a compound of Formula (I),
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. For all the reasons set forth above, dihydrobenzodioxine is better defined as a heterocyclic substituent. In direct support of this argument, the definition of “heterocycloalkyl” found in the instant specification is defined as “4 to 10-membered heterocycloalkyl.. (that is a).. partially unsaturated.. bicycle.. that contains.. 2.. heteroatoms selected from oxygen.” This definition of a heterocyclic system is directly descriptive of dihydrobenzodioxine. A heterocyclic substituent at position R6 is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
Further regarding claim 6, the claim recites the limitation "dihydrobenzodioxole" in position R6 within several chemical compound names recited within the claim. This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of R6 within claim 1, on which claim 6 is based. Specifically, R6 is defined as phenyl, naphthyl, nor heteroaryl group by claim 1. However, dihydrobenzodioxole is defined as neither a phenyl, naphthyl, or heteroaryl group. For example, the 6-(Azetidin-1-yl)-N-(5-chloro-2,2-difluoro-2H-1,3-benzodioxole-4-sulfonyl)-4-fluoro-1-benzofuran-2-carboxamide,
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defines a compound with a di(fluoro)benzodioxole at position R6,
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directly adjacent to the sulfonamide group of a compound of Formula (I),
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. For all the reasons set forth above, dihydrobenzodioxole is better defined as a heterocyclic substituent. In direct support of this argument, the definition of “heterocycloalkyl” found in the instant specification is defined as “4 to 10-membered heterocycloalkyl.. (that is a).. partially unsaturated.. bicycle.. that contains.. 2.. heteroatoms selected from oxygen.” This definition of a heterocyclic system is directly descriptive of dihydrobenzodioxole. A heterocyclic substituent at position R6 is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
Further regarding claim 6, the claim recites the limitation "tetrahydronaphthalene" in position R6 within several chemical compound names recited within the claim. This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of R6 within claim 1, on which claim 6 is based. Specifically, R6 is defined as phenyl, naphthyl, nor heteroaryl group by claim 1. However, tetrahydronaphthalene is defined as neither a phenyl, naphthyl, or heteroaryl group. For example, the 6-(Azetidin-1-yl)-4-fluoro-N-(4-methoxy-5,6,7,8-tetrahydronaphthalene-1-sulfonyl)-1-benzofuran-2-carboxamide
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defines a compound with tetrahydronaphthalene
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at position R6, directly adjacent to the sulfonamide group of a compound of Formula (I),
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. In applying the broadest reasonable interpretation, “naphthyl,”
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is defined as an aromatic substituent derived from naphthalene which is composed of two fused benzene rings, i.e. a fully unsaturated, aromatic p-system. In contrast, tetrahydronaphthyl (see above) is a substituent derived from tetralin, where one of the two rings is reduced, and the fused system is partially unsaturated and non-aromatic. These are unequivocally different substituents, and a person of ordinary skill in the art would treat these as distinct chemical species, with properties which are not interchangeable. For instance, naphthyl is planar and aromatic, while the introduction of sp3 carbon atoms in tetrahydronaphthyl reduces planarity, redistributes electron density, and alters sterics and reactivity. A tetrahydronaphthyl substituent at position R6 is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
Further regarding claim 6, the claim recites the limitation “azaspiro” in position Ra/Rb within several chemical compound names recited within the claim. This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of Ra/Rb within claim 1, on which claim 6 is based. Specifically, claim 1 recites wherein Ra and Rb together with the nitrogen atom to which they are attached form a 4- membered nitrogen-containing heterocycloalkyl group which is optionally substituted one, two or three times, each substituent independently selected from a halogen atom, a C1-C2-alkyl group, a C1-C2-haloalkyl group, a C1-C2-alkoxy group, a C1-C3-hydroxyalkyl group and a phenyl group. However, the azaspiro is a heterospirocyclic, which is not defined by the limitations of claim 1. For example, 6-(5-Azaspiro[2.3]hexan-5-yl)-N-(2-ethoxybenzene-1-sulfonyl)-1-benzofuran-2-carboxamide,
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defines a compound with an azaspiro
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at position Ra/Rb, directly adjacent to the core benzofuran ring in a compound of Formula (I),
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. Neither this, nor any other azaspiro substituent at position Ra/Rb is encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
Further regarding claim 6, the claim recites the limitation “cyano” recited within the claim. This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of R6 within claim 1, on which claim 6 is based. For example, 6-(Azetidin-1-yl)-N-[4-(2-cyanoethyl)benzene-1-sulfonyl]-4-fluoro-1-benzofuran-2-carboxamide,
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defines a compound with a cyano substituent
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substituted onto R6, directly adjacent to the sulfonamide in a compound of Formula (I). There is no cyano substituent encompassed at any position by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
Further regarding claim 6, the claim recites the limitation “pyrazol” recited R7/R8 within the claim. This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of NR7R8 within claim 1, on which claim 6 is based. For example, 6-(Azetidin-1-yl)-4-fluoro-N-{2-[(3-methyl-1-phenyl-1H-pyrazol-5-yl)amino]benzene-1-sulfonyl}-1-benzofuran-2-carboxamide,
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defines a compound with a N-pyrazolo substituent
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substituted onto R7/R8, directly adjacent to the sulfonamide ring in a compound of Formula (I). There is no heteroaryl substituent encompassed in the R7/R8 position by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
Further regarding claim 6, the claim recites the limitation “amido” recited in the substituents of R6 within the claim. This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of NR7R8 within claim 1, on which claim 6 is based. For example, 6-(Azetidin-1-yl)-4-fluoro-N-(5-propanamidonaphthalene-1-sulfonyl)-1-benzofuran-2-carboxamide,
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, defines a compound with a N-amido
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substituted onto R6, directly adjacent to the sulfonamide ring in a compound of Formula (I). There is no n N-amido substituent encompassed by the substituents of R6 or the NR7R8 position in the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. In contrast, the only substituent encompassed by the claims is (NR7R8)-(C=O)-, wherein the connection point is the carbon of the amido substituent. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
With respect to the example compounds included within the above rejections based on subject matter that is not within the scope of the claim on which it depends: the exemplary compounds are in no way a complete listing of the compounds within the claim. Over 200 unique compounds have been listed in claim 6. In the interest of brevity, only the names of the various substituents which contain subject matter that is not within the scope of claim 1 have been included so as to guide Applicant. To make the record clear, many more compounds listed in claim 6 are identified as including subject matter beyond that which is not defined by claim 1. Applicant is expected to properly address every instance in which the claim recites compounds whose limitations are not encompassed by the independent claim in any forthcoming amendments to claim 6, based on the substituents identified herein. Particular attention should be paid to MPEP § 608.04, regarding new matter upon amendment of the instant dependent claim, as well as the independent claim.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of pre-AIA 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6, 12, and 14 are rejected under 35 U.S.C. § 103 as being unpatentable over Bouche et al. (WO 2020216701 A1, effectively filed April 25, 2019 for the purposes of § 102(a)(2)), cited on Applicant IDS dated 05/08/2023), hereinafter Bouche.
The instant claims are drawn to a compound of Formula (I) elected to be the species,
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, and a pharmaceutical composition thereof, further comprising an anticancer agent.
Bouche teaches a compound of Formula (I) (claim 1 of Bouche, see instant claims 1-6), and a pharmaceutical composition thereof (claim 19 of Bouche, see instant claim 12), further comprising an anticancer agent (claim 21 of Bouche, see instant claim 14).
Regarding claims 1-6, Bouche renders obvious the elected species wherein,
R1, R2, R4, and R5 are hydrogen
R3 is fluoro
Ra and Rb together with the nitrogen atom to which they are attached form a 4-membered nitrogen-containing heterocycloalkyl
R6 is phenyl substituted with a 2-ethoxy group.
The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been prima facie obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (see MPEP § 2143 (I)(A)).
The interest of brevity, and because the claims are largely repetitive, the outlined teachings are herein applied to each claim individually and the claims collectively, thus, stand rejected.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 14, and, 15 of U.S. Patent No. US 12,357,603 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the elected species is encompassed by limitations of the patented claims. The patented claims (claims 1-12) teach a compound of Formula (I) would anticipate the elected species wherein,
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X is Oxygen (see instant claims 1-6)
R1, R2, R4, and R5 are hydrogen (see instant claims 1-6)
R3 is fluoro (see instant claims 1-6)
Ra and Rb together with the nitrogen atom to which they are attached form a 4-membered nitrogen-containing heterocycloalkyl (see instant claims 1-6)
R6 is phenyl substituted with a 2-ethoxy group (see instant claims 1-6)
Correspondence
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached on +1 (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is +1 (571) 273-8300.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623