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 .
DETAILED ACTION
Status of the Claims
Claims 1-3, 5, 7, 10, 16-19, 27, 30-33, 42, 44, 46, 48, and 59 are pending and are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on July 23rd 2024 and April 29th 2024 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 1-3, 5, 7, 10, 16-19, 27, 30-33, 42, 44, 46, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Cacatian (U.S. Patent No. 11,479,557 issued on April 1st 2020) in view of Pharmablock (Pharmablock, Tetrahydropyrans in Drug Discovery, White Paper, Accessed February 9th 2026, Published 201912).
The instant claims are directed towards a method of treating cancers, including hematological cancers, via administration of a compound of Formula (0):
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One such compound is:
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Cacatian teaches the treatment of leukemia (Cacatian, col. 407, claim 1) with compounds including:
N-ethyl-5-fluoro-N-isopropyl-2-((4-(7-(((1r,4r)-4-(methylsulfonamido)cyclohexyl)methyl)-2,7-diazaspiro[3.5]nonan-2-yl)pyrimidin-5-yl)oxy)benzamide (Cacatian, col. 416, claim 4):
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Applicant’s compound genus differs from said compound only in the replacement of the cyclohexyl moiety with a tetrahydropyran:
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Pharmablock teaches tetrahydropyrans as a common bioisosteric substitution for cyclohexanes (Pharmablock, pg. 1). One of ordinary skill in the art would therefore find the treatment of leukemias with applicant’s compounds, and thus claims 1-3, 5, 7, 10, 18, 27, 30, 32-33, 42, 44, 46 (each further limiting the compound genus of claim 1), and 48 (limiting the cancer of claim 1 to a hematological cancer) prima facie obvious.
Claims 1-3, 5, 7, 10, 16-19, 27, 30-33, 42, 44, 46, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Cacatian (U.S. Patent No. 11,479,557 issued on April 1st 2020) in view of Pharmablock and in further view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012).
Claims 16 and 17 further limit the R1 group of claim 1 to halogen-substituted ethyls. For the teachings of Cacatian and Pharmablock as they are relevant to claim 1, see the above 103 rejection for claim 1. Regarding the replacement of the R-1 ethyl (see above) with halogen-substituted ethyls, the replacement of hydrogens with halogens is a common bioisosteric substitution in the field of drug discovery (Brown, pg. 17), and claims 16 and 17 are therefore prima facie obvious.
Claim 19 limits the R1 of claim 1 to a cyclic group, such as cyclopropane. For the teachings of Cacatian and Pharmablock as they are relevant to claim 1, see the above 103 rejection for claim 1. Regarding the replacement of the R-1 isopropyl (see above) with a cyclopropyl, such a bioisosteric substitution is also known in the field of drug discovery (Brown, pg. 118), and claim 19 is thereby prima facie obvious.
Nonstatutory 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.
The instant claims are directed towards a method of treating cancers, including hematological cancers, via administration of a compound of Formula (0):
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Claims 1-3, 5, 7, 10, 16-19, 27, 30-33, 42, 44, 46, and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,919,901. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches the treatment of leukemia (a hematological cancer) via administration of equivalent compounds to those of the instant application.
Claims 1-3, 5, 7, 10, 18-19, 27, 30, 32-33, 42, 44, 46, and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,479,557 in view of Pharmablock (Pharmablock, Tetrahydropyrans in Drug Discovery, White Paper, Accessed February 9th 2026, Published 2019).
The instant claims are directed towards a method of treating cancers, including hematological cancers, via administration of a compound of Formula (0):
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One such compound is:
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The reference patent teaches the treatment of leukemia (reference patent, col. 407, claim 1) with compounds including:
N-ethyl-5-fluoro-N-isopropyl-2-((4-(7-(((1r,4r)-4-(methylsulfonamido)cyclohexyl)methyl)-2,7-diazaspiro[3.5]nonan-2-yl)pyrimidin-5-yl)oxy)benzamide (reference patent, col. 416, claim 4):
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Applicant’s compound genus differs from said compound only in the replacement of the cyclohexyl moiety with a tetrahydropyran:
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Pharmablock teaches tetrahydropyrans as a common bioisosteric substitution for cyclohexanes (Pharmablock, pg. 1). One of ordinary skill in the art would therefore find the treatment of leukemias with applicant’s compounds, and thus claims 1-3, 5, 7, 10, 18, 27, 30, 32-33, 42, 44, 46 (each further limiting the compound genus of claim 1), and 48 (limiting the cancer of claim 1 to a hematological cancer) prima facie obvious.
Claims 16, 17, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,479,557 in view of Pharmablock and in further view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012).
Claims 16 and 17 further limit the R1 group of claim 1 to halogen-substituted ethyls. For the teachings of the reference patent and Pharmablock as they are relevant to claim 1, see the above ODP rejection for claim 1. Regarding the replacement of the R-1 ethyl (see above) with halogen-substituted ethyls, the replacement of hydrogens with halogens is a common bioisosteric substitution in the field of drug discovery (Brown, pg. 17), and claims 16 and 17 are therefore prima facie obvious.
Claim 19 limits the R1 of claim 1 to a cyclic group, such as cyclopropane. For the teachings of the reference patent and Pharmablock as they are relevant to claim 1, see the above ODP rejection for claim 1. Regarding the replacement of the R-1 isopropyl (see above) with a cyclopropyl, such a bioisosteric substitution is also known in the field of drug discovery (Brown, pg. 118), and claim 19 is thereby prima facie obvious.
Claims 1-3, 5, 7, 10, 18, 27, 30, 32-33, 42, 44, 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 82-84 of copending Application No. 19/180,560 (US20250326764A1) in view of in view of Pharmablock (Pharmablock, Tetrahydropyrans in Drug Discovery, White Paper, Accessed February 9th 2026, Published 2019).
The instant claims are directed towards a method of treating cancers via administration of a compound of Formula (0):
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One such compound is:
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The ‘966 Application teaches the treatment of cancers with compounds including:
N-ethyl-5-fluoro-N-isopropyl-2-((4-(7-(((1r,4r)-4-(methylsulfonamido)cyclohexyl)methyl)-2,7-diazaspiro[3.5]nonan-2-yl)pyrimidin-5-yl)oxy)benzamide (‘560 Application, claims 82-84):
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Applicant’s compound genus differs from said compound only in the replacement of the cyclohexyl moiety with a tetrahydropyran:
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Pharmablock teaches tetrahydropyrans as a common bioisosteric substitution for cyclohexanes (Pharmablock, pg. 1). One of ordinary skill in the art would therefore find the treatment of cancers with applicant’s compounds, and thus claims 1-3, 5, 7, 10, 18, 27, 30, 32-33, 42, 44, 46 (each further limiting the compound genus of claim 1) are prima facie obvious.
This is a provisional nonstatutory double patenting rejection.
Claims 16, 17, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 82-84 of copending Application No. 19/180,560 (US20250326764A1) in view of Pharmablock and in further view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012).
Claims 16 and 17 further limit the R1 group of claim 1 to halogen-substituted ethyls. For the teachings of Cacatian and Pharmablock as they are relevant to claim 1, see the above ODP rejection for claim 1. Regarding the replacement of the R-1 ethyl (see above) with halogen-substituted ethyls, the replacement of hydrogens with halogens is a common bioisosteric substitution in the field of drug discovery (Brown, pg. 17), and claims 16 and 17 are therefore prima facie obvious.
Claim 19 limits the R1 of claim 1 to a cyclic group, such as cyclopropane. For the teachings of Cacatian and Pharmablock as they are relevant to claim 1, see the above ODP rejection for claim 1. Regarding the replacement of the R-1 isopropyl (see above) with a cyclopropyl, such a bioisosteric substitution is also known in the field of drug discovery (Brown, pg. 118), and claim 19 is thereby prima facie obvious.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 5, 7, 10, 18-19, 27, 30, 32-33, 42, 44, 46, and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 83-100 of copending Application No. 18/863,966 (US20250295661A1) in view of Pharmablock (Pharmablock, Tetrahydropyrans in Drug Discovery, White Paper, Accessed February 9th 2026, Published 2019).
The instant claims are directed towards a method of treating cancers via administration of a compound of Formula (0):
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One such compound is:
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The ‘966 Application teaches the treatment of hematological cancers with compounds including:
N-ethyl-5-fluoro-N-isopropyl-2-((4-(7-(((1r,4r)-4-(methylsulfonamido)cyclohexyl)methyl)-2,7-diazaspiro[3.5]nonan-2-yl)pyrimidin-5-yl)oxy)benzamide (‘966 Application, claim 83):
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Applicant’s compound genus differs from said compound only in the replacement of the cyclohexyl moiety with a tetrahydropyran:
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Pharmablock teaches tetrahydropyrans as a common bioisosteric substitution for cyclohexanes (Pharmablock, pg. 1). One of ordinary skill in the art would therefore find the treatment of cancers with applicant’s compounds, and thus claims 1-3, 5, 7, 10, 18, 27, 30, 32-33, 42, 44, 46 (each further limiting the compound genus of claim 1) and claims 48 (limiting the cancer of claim 1 to a hematological cancer) are prima facie obvious.
This is a provisional nonstatutory double patenting rejection.
Claims 16, 17, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 83-100 of copending Application No. 18/863,966 (US20250295661A1) in view of Pharmablock and in further view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012).
Claims 16 and 17 further limit the R1 group of claim 1 to halogen-substituted ethyls. For the teachings of Cacatian and Pharmablock as they are relevant to claim 1, see the above ODP rejection for claim 1. Regarding the replacement of the R-1 ethyl (see above) with halogen-substituted ethyls, the replacement of hydrogens with halogens is a common bioisosteric substitution in the field of drug discovery (Brown, pg. 17), and claims 16 and 17 are therefore prima facie obvious.
Claim 19 limits the R1 of claim 1 to a cyclic group, such as cyclopropane. For the teachings of Cacatian and Pharmablock as they are relevant to claim 1, see the above ODP rejection for claim 1. Regarding the replacement of the R-1 isopropyl (see above) with a cyclopropyl, such a bioisosteric substitution is also known in the field of drug discovery (Brown, pg. 118), and claim 19 is thereby prima facie obvious.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 5, 7, 10, 18-19, 27, 30, 32-33, 42, 44, 46, 48, and 59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, 12, 17, 34-57, and 63-65 of copending Application No. 17/917,193 (US20230165858A1) in view of Pharmablock (Pharmablock, Tetrahydropyrans in Drug Discovery, White Paper, Accessed February 9th 2026, Published 2019).
The instant claims are directed towards a method of treating cancers via administration of a compound of Formula (0):
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One such compound is:
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The ‘193 Application teaches the treatment of lymphomas with compounds including:
N-ethyl-5-fluoro-N-isopropyl-2-((4-(7-(((1r,4r)-4-(methylsulfonamido)cyclohexyl)methyl)-2,7-diazaspiro[3.5]nonan-2-yl)pyrimidin-5-yl)oxy)benzamide (‘193 Application, claim 39):
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Applicant’s compound genus differs from said compound only in the replacement of the cyclohexyl moiety with a tetrahydropyran:
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Pharmablock teaches tetrahydropyrans as a common bioisosteric substitution for cyclohexanes (Pharmablock, pg. 1). One of ordinary skill in the art would therefore find the treatment of cancers with applicant’s compounds, and thus claims 1-3, 5, 7, 10, 18, 27, 30, 32-33, 42, 44, 46 (each further limiting the compound genus of claim 1) and claims 48 and 59 (limiting the cancer of claim 1 to a lymphoma) are prima facie obvious.
This is a provisional nonstatutory double patenting rejection.
Claims 16, 17, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, 12, 17, 34-57, and 63-65 of copending Application No. 17/917,193 (US20230165858A1) in view of Pharmablock and in further view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012).
Claims 16 and 17 further limit the R1 group of claim 1 to halogen-substituted ethyls. For the teachings of Cacatian and Pharmablock as they are relevant to claim 1, see the above ODP rejection for claim 1. Regarding the replacement of the R-1 ethyl (see above) with halogen-substituted ethyls, the replacement of hydrogens with halogens is a common bioisosteric substitution in the field of drug discovery (Brown, pg. 17), and claims 16 and 17 are therefore prima facie obvious.
Claim 19 limits the R1 of claim 1 to a cyclic group, such as cyclopropane. For the teachings of Cacatian and Pharmablock as they are relevant to claim 1, see the above ODP rejection for claim 1. Regarding the replacement of the R-1 isopropyl (see above) with a cyclopropyl, such a bioisosteric substitution is also known in the field of drug discovery (Brown, pg. 118), and claim 19 is thereby prima facie obvious.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 5, 7, 10, 18-19, 27, 30, 32-33, 42, 44, and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 19/458,303 in view of Pharmablock (Pharmablock, Tetrahydropyrans in Drug Discovery, White Paper, Accessed February 9th 2026, Published 2019).
The instant claims are directed towards a method of treating cancers via administration of a compound of Formula (0):
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One such compound is:
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The ‘303 Application teaches the treatment of cancer with compounds including:
N-ethyl-5-fluoro-N-isopropyl-2-((4-(7-(((1r,4r)-4-(methylsulfonamido)cyclohexyl)methyl)-2,7-diazaspiro[3.5]nonan-2-yl)pyrimidin-5-yl)oxy)benzamide (‘303 Application, claim 31):
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Applicant’s compound genus differs from said compound only in the replacement of the cyclohexyl moiety with a tetrahydropyran:
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Pharmablock teaches tetrahydropyrans as a common bioisosteric substitution for cyclohexanes (Pharmablock, pg. 1). One of ordinary skill in the art would therefore find the treatment of cancers with applicant’s compounds, and thus claims 1-3, 5, 7, 10, 18, 27, 30, 32-33, 42, 44, 46 (each further limiting the compound genus of claim 1) prima facie obvious.
This is a provisional nonstatutory double patenting rejection.
Claims 16, 17, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of of copending Application No. 19/458,303 in view of Pharmablock and in further view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012).
Claims 16 and 17 further limit the R1 group of claim 1 to halogen-substituted ethyls. For the teachings of Cacatian and Pharmablock as they are relevant to claim 1, see the above ODP rejection for claim 1. Regarding the replacement of the R-1 ethyl (see above) with halogen-substituted ethyls, the replacement of hydrogens with halogens is a common bioisosteric substitution in the field of drug discovery (Brown, pg. 17), and claims 16 and 17 are therefore prima facie obvious.
Claim 19 limits the R1 of claim 1 to a cyclic group, such as cyclopropane. For the teachings of Cacatian and Pharmablock as they are relevant to claim 1, see the above ODP rejection for claim 1. Regarding the replacement of the R-1 isopropyl (see above) with a cyclopropyl, such a bioisosteric substitution is also known in the field of drug discovery (Brown, pg. 118), and claim 19 is thereby prima facie obvious.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1For evidence of publishing date, see the attached 2019 Pharmablock promotional email referencing the above white paper (Pharmablock, promotion.pharmablock.com/20190318134956/index.html, Promotional Email, Accessed February 9th 2026, published 2019)
2For evidence of publishing date, see the attached Pharmablock Linkedin post referencing the above white paper (Pharmablock, linkedin.com/posts/celine-chen-2355a247_follow-pharmablock-on-linkedin-and-you-will-activity-6521027213083672576-V8wK, Linkedin Post, Accessed February 9th 2026, published 2020)