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 present application claims priority to the application, IN2022/11038517, with the effective filing date of 5 July 2022. The Examiner notes Applicant’s remarks confirming that the priority application, IN2022/11038517, is a certified copy.
Claim Status
This Office Action is in response to Applicant’s Amendment filed, 5 May 2026. Claims 11-15 were previously canceled and claims 3, 8, and 16-25 were previously withdrawn.
Claims 1-2, 4-7, and 9-10 are pending.
Information Disclosure Statement
The Information Disclosure Statement filed on 5 May 2026 and the references cited therein have been considered, unless indicated otherwise.
The reference, Miloh (AASLD abstract), wherein a copy was provided but is illegible, is lined through.
Rejections New/Maintained
Claim Rejections – 35 U.S.C. § 103
1. (Maintained) Claims 1-2, 4-7, and 9-10 were rejected under 35 U.S.C. 103 as being unpatentable over Jung (U.S. Patent No. 9,890,129, issued 13 Feb 2019; of record, see PTO-892 mailed 5 Feb 2026) in view of Surur (Arch. Pharm. Chem. Life Sci., 2019, 352(e1800248), 1-11; of record, see PTO-892 mailed 5 Feb 2026).
Applicant's arguments filed 5 May 2026 have been fully considered but they are not persuasive.
Applicant argues that neither Jung nor Surur, taken alone or together, provides teachings or suggestions for making the specific modifications to the cited compound of Jung. Applicant further argues a person of ordinary skill in the art would not have been motivated to modify the cited compound of Jung in the manner of the present invention and especially not with a reasonable expectation of success. Additionally, Applicant argues that the Office solely based the rejection on alleged structural similarity of bioisostere equivalents of nitrogen and sulfur.
In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine Jung and Surur, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Jung teaches compounds and compositions of aminoalkylbenzothiazepine derivatives,
-Jung teaches 2-(((3,3-dibutyl-7-methylthio-1,1-dioxido-5-phenyl-2,3,4,5- tetrahydrobenzo[b][1,4]thiazepine-8-yl)methyl)amino)acetic acid, which has structure:
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160
235
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,
-Jung teaches R6 (R2 in the instant application) is C1-C6 alkyl, which significantly overlaps with the instant application (C1-C4 alkyl),
-Surur teaches sulfides can take part in attractive non-bonding interactions, which maintain the active conformation of the molecule, due to the low-lying C-S σ* orbital on sulfur,
-Surur teaches C-S σ* orbital allows for the phenomenon known as σ-holes, which possess a positive electrostatic potential and can interact with electron donating nitrogen or oxygen atoms, and sulfur can donate electrons into the σ-holes of various halogens,
-Surur teaches sulfur-aromatic interactions are common in proteins and have significant impact on recognition and binding of pharmaceuticals,
-Surur teaches sulfides feature longer bonds and narrow central bond angle,
-Surur teaches sulfides undergo rapid oxidative metabolism, which can be of paramount importance if the aftermath of long-lasting activity outweighs the short-term benefits, and
-Surur teaches that sulfides are prodrugs for sulfoxides and improve water solubility (page 6, column 1, paragraph 2).
As such, an artisan having ordinary skill in the art would have been motivated to combine the selected teachings from Jung and Surur to arrive at a compound of Formula (I):
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142
181
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, specifically the compound: 2-(((3-butyl-3-ethyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,5-benzothiazepin-8- yl)methyl)thio)acetic acid, which has structure:
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141
257
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.
Additionally, Applicant makes the assertion that the Examiner relied on the argument that nitrogen and sulfur are bioisostere equivalents. However, the Examiner notes that this is not one of the bases of the rejection and further does not dispute that nitrogen and sulfur are not bioisostere equivalents.
Thus, the rejection of claims 1-2, 4-7, and 9-10 as being unpatentable over Jung in view of Surur is maintained.
Claim Rejections – Nonstatutory Double Patenting
2. (Maintained) Claims 1-2, 4-7, and 9-10 were rejected on the ground of nonstatutory double patenting over claims 1-9 of U.S. Patent No. 10,975,045 in view of Jung (U.S. Patent No. 9,890,129, issued 13 Feb 2019; of record, see PTO-892 mailed 5 Feb 2026) and Surur (Arch. Pharm. Chem. Life Sci., 2019, 352(e1800248), 1-11; of record, see PTO-892 mailed 5 Feb 2026).
Applicant's arguments filed 5 May 2026 have been fully considered but they are not persuasive.
Applicant argues that there is no overlap of scope between the instant claims and the reference claims. Additionally, Applicant argues that the Office does not articulate motivation to modify or reasonable expectation of success.
In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine Jung and Surur, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘045 teaches a compound of Formula (I):
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154
190
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,
-Jung teaches compounds and compositions of aminoalkylbenzothiazepine derivatives,
-Jung teaches 2-(((3,3-dibutyl-7-methylthio-1,1-dioxido-5-phenyl-2,3,4,5- tetrahydrobenzo[b][1,4]thiazepine-8-yl)methyl)amino)acetic acid, which has structure:
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160
235
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,
-Jung teaches R6 (R2 in the instant application) is C1-C6 alkyl, which significantly overlaps with the instant application (C1-C4 alkyl),
-Surur teaches sulfides can take part in attractive non-bonding interactions, which maintain the active conformation of the molecule, due to the low-lying C-S σ* orbital on sulfur,
-Surur teaches C-S σ* orbital allows for the phenomenon known as σ-holes, which possess a positive electrostatic potential and can interact with electron donating nitrogen or oxygen atoms, and sulfur can donate electrons into the σ-holes of various halogens,
-Surur teaches sulfur-aromatic interactions are common in proteins and have significant impact on recognition and binding of pharmaceuticals,
-Surur teaches sulfides feature longer bonds and narrow central bond angle,
-Surur teaches sulfides undergo rapid oxidative metabolism, which can be of paramount importance if the aftermath of long-lasting activity outweighs the short-term benefits, and
-Surur teaches that sulfides are prodrugs for sulfoxides and improve water solubility (page 6, column 1, paragraph 2).
As such, an artisan having ordinary skill in the art would have been motivated to combine the selected teachings from Jung and Surur to arrive at a compound of Formula (I):
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142
181
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, specifically the compound: 2-(((3-butyl-3-ethyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,5-benzothiazepin-8- yl)methyl)thio)acetic acid, which has structure:
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141
257
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.
Thus, the rejection of claims 1-2, 4-7, and 9-10 on the ground of nonstatutory double patenting over claims 1-9 of U.S. Patent No. 10,975,045 in view of Jung and Surur is maintained.
3. (Maintained) Claims 1-2, 4-7, and 9-10 were rejected on the ground of nonstatutory double patenting over claims 1-2, 4-7, and 10 of U.S. Patent No. 10,941,127 in view of Jung (U.S. Patent No. 9,890,129, issued 13 Feb 2019; of record, see PTO-892 mailed 5 Feb 2026) and Surur (Arch. Pharm. Chem. Life Sci., 2019, 352(e1800248), 1-11; of record, see PTO-892 mailed 5 Feb 2026).
Applicant's arguments filed 5 May 2026 have been fully considered but they are not persuasive.
Applicant argues that there is no overlap of scope between the instant claims and the reference claims. Additionally, Applicant argues that the Office does not articulate motivation to modify or reasonable expectation of success.
In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine Jung and Surur, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘127 teaches a compound of Formula (I):
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159
206
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,
-Jung teaches compounds and compositions of aminoalkylbenzothiazepine derivatives,
-Jung teaches 2-(((3,3-dibutyl-7-methylthio-1,1-dioxido-5-phenyl-2,3,4,5- tetrahydrobenzo[b][1,4]thiazepine-8-yl)methyl)amino)acetic acid, which has structure:
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160
235
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,
-Jung teaches R6 (R2 in the instant application) is C1-C6 alkyl, which significantly overlaps with the instant application (C1-C4 alkyl),
-Surur teaches sulfides can take part in attractive non-bonding interactions, which maintain the active conformation of the molecule, due to the low-lying C-S σ* orbital on sulfur,
-Surur teaches C-S σ* orbital allows for the phenomenon known as σ-holes, which possess a positive electrostatic potential and can interact with electron donating nitrogen or oxygen atoms, and sulfur can donate electrons into the σ-holes of various halogens,
-Surur teaches sulfur-aromatic interactions are common in proteins and have significant impact on recognition and binding of pharmaceuticals,
-Surur teaches sulfides feature longer bonds and narrow central bond angle,
-Surur teaches sulfides undergo rapid oxidative metabolism, which can be of paramount importance if the aftermath of long-lasting activity outweighs the short-term benefits, and
-Surur teaches that sulfides are prodrugs for sulfoxides and improve water solubility (page 6, column 1, paragraph 2).
As such, an artisan having ordinary skill in the art would have been motivated to combine the selected teachings from Jung and Surur to arrive at a compound of Formula (I):
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142
181
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, specifically the compound: 2-(((3-butyl-3-ethyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,5-benzothiazepin-8- yl)methyl)thio)acetic acid, which has structure:
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141
257
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.
Thus, the rejection of claims 1-2, 4-7, and 9-10 on the ground of nonstatutory double patenting over claims 1-2, 4-7, and 10 of U.S. Patent No. 10,941,127 in view of Jung and Surur is maintained.
4. (Maintained) Claims 1-2, 4-7, and 9-10 were rejected on the ground of nonstatutory double patenting over claims 1-2, 4-7, and 10 of U.S. Patent No. 11,014,898 in view of Jung (U.S. Patent No. 9,890,129, issued 13 Feb 2019; of record, see PTO-892 mailed 5 Feb 2026) and Surur (Arch. Pharm. Chem. Life Sci., 2019, 352(e1800248), 1-11; of record, see PTO-892 mailed 5 Feb 2026).
Applicant's arguments filed 5 May 2026 have been fully considered but they are not persuasive.
Applicant argues that there is no overlap of scope between the instant claims and the reference claims. Additionally, Applicant argues that the Office does not articulate motivation to modify or reasonable expectation of success.
In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine Jung and Surur, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘898 teaches a compound of Formula (I):
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158
194
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,
-Jung teaches compounds and compositions of aminoalkylbenzothiazepine derivatives,
-Jung teaches 2-(((3,3-dibutyl-7-methylthio-1,1-dioxido-5-phenyl-2,3,4,5- tetrahydrobenzo[b][1,4]thiazepine-8-yl)methyl)amino)acetic acid, which has structure:
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160
235
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,
-Jung teaches R6 (R2 in the instant application) is C1-C6 alkyl, which significantly overlaps with the instant application (C1-C4 alkyl),
-Surur teaches sulfides can take part in attractive non-bonding interactions, which maintain the active conformation of the molecule, due to the low-lying C-S σ* orbital on sulfur,
-Surur teaches C-S σ* orbital allows for the phenomenon known as σ-holes, which possess a positive electrostatic potential and can interact with electron donating nitrogen or oxygen atoms, and sulfur can donate electrons into the σ-holes of various halogens,
-Surur teaches sulfur-aromatic interactions are common in proteins and have significant impact on recognition and binding of pharmaceuticals,
-Surur teaches sulfides feature longer bonds and narrow central bond angle,
-Surur teaches sulfides undergo rapid oxidative metabolism, which can be of paramount importance if the aftermath of long-lasting activity outweighs the short-term benefits, and
-Surur teaches that sulfides are prodrugs for sulfoxides and improve water solubility (page 6, column 1, paragraph 2).
As such, an artisan having ordinary skill in the art would have been motivated to combine the selected teachings from Jung and Surur to arrive at a compound of Formula (I):
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142
181
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, specifically the compound: 2-(((3-butyl-3-ethyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,5-benzothiazepin-8- yl)methyl)thio)acetic acid, which has structure:
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141
257
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.
Thus, the rejection of claims 1-2, 4-7, and 9-10 on the ground of nonstatutory double patenting over claims 1-2, 4-7, and 10 of U.S. Patent No. 11,014,898 in view of Jung and Surur is maintained.
5. (Maintained) Claims 1-2, 4-7, and 9-10 were rejected on the ground of nonstatutory double patenting over claims 1-2, 4-7, and 10 of U.S. Patent No. 11,225,466 in view of Jung (U.S. Patent No. 9,890,129, issued 13 Feb 2019; of record, see PTO-892 mailed 5 Feb 2026) and Surur (Arch. Pharm. Chem. Life Sci., 2019, 352(e1800248), 1-11; of record, see PTO-892 mailed 5 Feb 2026).
Applicant's arguments filed 5 May 2026 have been fully considered but they are not persuasive.
Applicant argues that there is no overlap of scope between the instant claims and the reference claims. Additionally, Applicant argues that the Office does not articulate motivation to modify or reasonable expectation of success.
In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine Jung and Surur, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘466 teaches a compound of Formula (I):
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156
194
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,
-Jung teaches compounds and compositions of aminoalkylbenzothiazepine derivatives,
-Jung teaches 2-(((3,3-dibutyl-7-methylthio-1,1-dioxido-5-phenyl-2,3,4,5- tetrahydrobenzo[b][1,4]thiazepine-8-yl)methyl)amino)acetic acid, which has structure:
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160
235
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,
-Jung teaches R6 (R2 in the instant application) is C1-C6 alkyl, which significantly overlaps with the instant application (C1-C4 alkyl),
-Surur teaches sulfides can take part in attractive non-bonding interactions, which maintain the active conformation of the molecule, due to the low-lying C-S σ* orbital on sulfur,
-Surur teaches C-S σ* orbital allows for the phenomenon known as σ-holes, which possess a positive electrostatic potential and can interact with electron donating nitrogen or oxygen atoms, and sulfur can donate electrons into the σ-holes of various halogens,
-Surur teaches sulfur-aromatic interactions are common in proteins and have significant impact on recognition and binding of pharmaceuticals,
-Surur teaches sulfides feature longer bonds and narrow central bond angle,
-Surur teaches sulfides undergo rapid oxidative metabolism, which can be of paramount importance if the aftermath of long-lasting activity outweighs the short-term benefits, and
-Surur teaches that sulfides are prodrugs for sulfoxides and improve water solubility (page 6, column 1, paragraph 2).
As such, an artisan having ordinary skill in the art would have been motivated to combine the selected teachings from Jung and Surur to arrive at a compound of Formula (I):
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142
181
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, specifically the compound: 2-(((3-butyl-3-ethyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,5-benzothiazepin-8- yl)methyl)thio)acetic acid, which has structure:
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141
257
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.
Thus, the rejection of claims 1-2, 4-7, and 9-10 on the ground of nonstatutory double patenting over claims 1-2, 4-7, and 10 of U.S. Patent No. 11,225,466 in view of Jung and Surur is maintained.
6. (Maintained) Claims 1-2, 4-7, and 9-10 were rejected on the ground of nonstatutory double patenting over claims 1-2, 4-7, and 10 of U.S. Patent No. 11,377,429 in view of Jung (U.S. Patent No. 9,890,129, issued 13 Feb 2019; of record, see PTO-892 mailed 5 Feb 2026) and Surur (Arch. Pharm. Chem. Life Sci., 2019, 352(e1800248), 1-11; of record, see PTO-892 mailed 5 Feb 2026).
Applicant's arguments filed 5 May 2026 have been fully considered but they are not persuasive.
Applicant argues that there is no overlap of scope between the instant claims and the reference claims. Additionally, Applicant argues that the Office does not articulate motivation to modify or reasonable expectation of success.
In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine Jung and Surur, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘429 teaches a compound of Formula (I):
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151
196
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,
-Jung teaches compounds and compositions of aminoalkylbenzothiazepine derivatives,
-Jung teaches 2-(((3,3-dibutyl-7-methylthio-1,1-dioxido-5-phenyl-2,3,4,5- tetrahydrobenzo[b][1,4]thiazepine-8-yl)methyl)amino)acetic acid, which has structure:
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160
235
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,
-Jung teaches R6 (R2 in the instant application) is C1-C6 alkyl, which significantly overlaps with the instant application (C1-C4 alkyl),
-Surur teaches sulfides can take part in attractive non-bonding interactions, which maintain the active conformation of the molecule, due to the low-lying C-S σ* orbital on sulfur,
-Surur teaches C-S σ* orbital allows for the phenomenon known as σ-holes, which possess a positive electrostatic potential and can interact with electron donating nitrogen or oxygen atoms, and sulfur can donate electrons into the σ-holes of various halogens,
-Surur teaches sulfur-aromatic interactions are common in proteins and have significant impact on recognition and binding of pharmaceuticals,
-Surur teaches sulfides feature longer bonds and narrow central bond angle,
-Surur teaches sulfides undergo rapid oxidative metabolism, which can be of paramount importance if the aftermath of long-lasting activity outweighs the short-term benefits, and
-Surur teaches that sulfides are prodrugs for sulfoxides and improve water solubility (page 6, column 1, paragraph 2).
As such, an artisan having ordinary skill in the art would have been motivated to combine the selected teachings from Jung and Surur to arrive at a compound of Formula (I):
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142
181
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, specifically the compound: 2-(((3-butyl-3-ethyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,5-benzothiazepin-8- yl)methyl)thio)acetic acid, which has structure:
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141
257
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.
Thus, the rejection of claims 1-2, 4-7, and 9-10 on the ground of nonstatutory double patenting over claims 1-2, 4-7, and 10 of U.S. Patent No. 11,377,429 in view of Jung and Surur is maintained.
7. (Maintained) Claims 1-2, 4-7, and 9-10 were rejected on the ground of nonstatutory double patenting over claims 1-2, 4-7, and 10 of U.S. Application No. 18/164,185 (issued as U.S. Patent No. 12,187,690) in view of Jung (U.S. Patent No. 9,890,129, issued 13 Feb 2019; of record, see PTO-892 mailed 5 Feb 2026) and Surur (Arch. Pharm. Chem. Life Sci., 2019, 352(e1800248), 1-11; of record, see PTO-892 mailed 5 Feb 2026).
Applicant's arguments filed 5 May 2026 have been fully considered but they are not persuasive.
Applicant argues that there is no overlap of scope between the instant claims and the reference claims. Additionally, Applicant argues that the Office does not articulate motivation to modify or reasonable expectation of success.
In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine Jung and Surur, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘185 teaches a compound of Formula (I):
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123
195
media_image9.png
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,
-Jung teaches compounds and compositions of aminoalkylbenzothiazepine derivatives,
-Jung teaches 2-(((3,3-dibutyl-7-methylthio-1,1-dioxido-5-phenyl-2,3,4,5- tetrahydrobenzo[b][1,4]thiazepine-8-yl)methyl)amino)acetic acid, which has structure:
PNG
media_image1.png
160
235
media_image1.png
Greyscale
,
-Jung teaches R6 (R2 in the instant application) is C1-C6 alkyl, which significantly overlaps with the instant application (C1-C4 alkyl),
-Surur teaches sulfides can take part in attractive non-bonding interactions, which maintain the active conformation of the molecule, due to the low-lying C-S σ* orbital on sulfur,
-Surur teaches C-S σ* orbital allows for the phenomenon known as σ-holes, which possess a positive electrostatic potential and can interact with electron donating nitrogen or oxygen atoms, and sulfur can donate electrons into the σ-holes of various halogens,
-Surur teaches sulfur-aromatic interactions are common in proteins and have significant impact on recognition and binding of pharmaceuticals,
-Surur teaches sulfides feature longer bonds and narrow central bond angle,
-Surur teaches sulfides undergo rapid oxidative metabolism, which can be of paramount importance if the aftermath of long-lasting activity outweighs the short-term benefits, and
-Surur teaches that sulfides are prodrugs for sulfoxides and improve water solubility (page 6, column 1, paragraph 2).
As such, an artisan having ordinary skill in the art would have been motivated to combine the selected teachings from Jung and Surur to arrive at a compound of Formula (I):
PNG
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142
181
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, specifically the compound: 2-(((3-butyl-3-ethyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,5-benzothiazepin-8- yl)methyl)thio)acetic acid, which has structure:
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141
257
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.
Thus, the rejection of claims 1-2, 4-7, and 9-10 on the ground of nonstatutory double patenting over claims 1-2, 4-7, and 10 of U.S. Application No. 18/164,185 (issued as U.S. Patent No. 12,187,690) in view of Jung and Surur is maintained.
Conclusion
No claim is allowed.
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/MADELINE M. DEKARSKE/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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