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 .
Election/Restrictions
A new search was performed for a species wherein variables A1 through A6 are each C, X and Y are each N, variables R1 and R2 combine to form a 3-, 4-, 5-, or 6-membered heterocycloalkyl (substituted or unsubstituted), and for all variables R3 through R6, with prior art retrieved (See Updated STN Search, Search Notes). The search was then stopped as prior art was retrieved.
Claims 5-9, 15, 18-27, and 29-31 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species and group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4 December 2025.
Current Status of 17/999,408
Claim 1 has undergone amendments. Claim 34 is newly added. Thus, Claims 1, 2, 4, 16, 33 and 34, submitted on 12 May 2026, represent all claims currently under consideration.
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.
Response to Arguments
The rejections over Luk (WO 00/35920) are withdrawn. The currently amended compounds require a non-hydrogen atom at the variable R3 position, and there is no teaching, suggestion, or motivation found in Luk to substitute out the hydrogen which is present in the analogous variable R3 position.
The rejection over Schiller (US 2022/0213089) is maintained. While Applicant has amended the claims to require that variable R3 is other than hydrogen, Schiller discloses several compounds which have the analogous variable R3 position containing cyano, halogen, and heterocycloalkyl.
The rejections over Chen (WO 2018/002848) are withdrawn. Applicant has amended the claims to require that variable R3 is not hydrogen, and Chen does not disclose or suggest a compound where the analogous variable R3 is not hydrogen.
The rejections over Simoneau (WO 2005/042530) are withdrawn. Applicant has amended the claims to require that only variables R1 and R2 can come together to form a heterocycloalkyl, with the compounds of Simoneau having analogous variables R3 and R4 coming together to form a heterocycloalkyl.
The rejections over Deshmukh are each withdrawn. The compounds of Deshmukh each have variable R3 as hydrogen, and there is no teaching, suggestion, or motivation found to replace this hydrogen with another group.
The provisional non-statutory double patenting rejection of Claims 1-2, 4, 16, and 33 over Claims 1, 3, 5, and 10 of co-pending application No. 19/140,283 is maintained as it is not the only rejection remaining.
Claim Rejections - 35 USC § 102- REJECTIONS MAINTAINED AND NEW GROUNDS OF REJECTION
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 4, 16, and 33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Schiller (US 2022/0213089; Publication Date: 7 July 2022; Priority to 15 March 2019).
Schiller discloses inhibitors of CBP/p300 bromodomains (Abstract). Compounds disclosed include
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(Figure 1, Sheet 61),
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(Figure 1, Sheet 62), and
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(Figure 1, Sheet 63). These compounds have variables A1-A6 each as C, variable R1 and R2 coming together to form a substituted heterocycloalkyl, variable R3 as halogen, cyano, or heterocycloalkyl, variable R4 as hydrogen, variable R5 as substituted alkyl, and variable R6 as substituted cycloalkyl. Another aspect of the present disclosure relates to a pharmaceutical composition comprising a compound of the invention and a pharmaceutically acceptable carrier (Paragraph 0024).
Claims 1, 2, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 1869989-84-3 (Entered STN: 18 February 2016).
STN Registry No. 1869989-84-3
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has variables R1 and R2 coming together to form a 5-membered heterocycloalkyl, variables R3 and R4 each as methoxy, and variables R5 and R6 each as hydrogen.
Claims 1, 2, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 1349431-61-3 (Entered STN: 6 December 2011).
STN Registry No. 1349431-61-3
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has variables R1 and R2 coming together to form a 5-membered heterocycloalkyl, variables R3 and R4 each as fluorine, variable R5 as H, and variable R6 as substituted thio.
Claims 1, 2, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 159724-75-1 (Entered STN: 22 December 1994).
STN Registry No. 159724-75-1
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has variables R1 and R2 coming together to form a 5-membered heterocycloalkyl, variable R3 as bromine, and variables R5 and R6 each as H.
Claims 1, 2, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 1350279-00-3 (Entered STN: 7 December 2011).
STN Registry No. 1350279-00-3
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has variables R1 and R2 coming together to form a 6-membered heterocycloalkyl, variable R3 as substituted amino, variable R5 as methyl, and variable R6 as trifluoromethyl.
Claims 1, 2, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 1350153-52-4 (Entered STN: 7 December 2011).
STN Registry No. 1350153-52-4
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has variables R1 and R2 coming together to form a 6-membered heterocycloalkyl, variable R3 as alkoxy, variable R5 as methyl, and variable R6 as cycloalkyl.
Claims 1, 2, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 1350042-43-1 (Entered STN: 7 December 2011).
STN Registry No. 1350042-43-1
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has variables R1 and R2 coming together to form a 6-membered heterocycloalkyl, variable R3 as alkoxy, variable R5 as methyl, and variable R6 as trifluoromethyl.
Claims 1, 2, 16, and 33-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grillot (WO 02/060879; Publication Date: 8 August 2002).
Grillot discloses the species
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(Page 18, Compound 25), which has variables R1 and R2 coming together to form a 6-membered substituted heterocycle, variable R3 as heteroaryl, variable R6 as substituted amino, and variables X and Y each as N. Pharmaceutical compositions of the invention are also disclosed (Page 56, Lines 23-26).
Claims 1, 2, 16, and 33-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gharat (WO 2012/055995; Publication Date: 3 May 2012).
Gharat discloses the species
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(Example 156, Page 167),
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(Example 161, Page 169), and
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(Example 162, Page 170), which each have variables R1 and R2 coming together to form a substituted heterocycloalkyl, variable R3 as substituted heteroaryl, and variable R6 as substituted amine. The present invention also provides a pharmaceutical composition that includes at least one compound described herein and at least one pharmaceutically acceptable excipient (Page 21).
Claims 1, 2, 16, and 33-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Palmer (WO 2008/095912; Publication Date: 14 August 2008).
Palmer discloses compounds which inhibit the secretion of gastric acid (Abstract). Palmer discloses compounds of the genus
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(Page 41), with variable R1 being alkyl, R2 being alkyl or H, and Ar being substituted phenyl groups (Table 1, Pages 41-66). These compounds have variable R1 and R2 coming together to form a 6-membered heterocycloalkyl, R3 being substituted heteroaryl, variable R5 as H or methyl, and variable R6 as alkyl. A further subject of the invention are medicaments which comprise one or more active compounds according to the invention. As medicaments, the active compounds are employed in combination with suitable pharmaceutical excipients (Page 100).
Claims 1, 2, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Palmer (Tetrahedron Letters, Vol. 50, Issue 27, 8 July 2009, 3920-3922).
Palmer discloses compounds such as
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, and
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(Schemes 2 and 3). These compounds have R1 and R2 coming together to form a substituted heterocycloalkyl, variable R3 as amine, substituted amine, or substituted heterocycle, and variables R5 and R6 each as methyl.
Double Patenting- REJECTIONS MAINTAINED
Claims 1, 2, 4, 16, and 33-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, and 10 of copending Application No. 19/140,283 (Amended Claims of 22 July 2025) (‘283).
Claim 1 of ‘283 is directed to a compound of structure 1A or 1B
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wherein X and Y are selected from C or N;
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. Claim 3 of ‘283 is directed to the compound of Claim 1 represented by formula IIA
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or IIB
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. Claim 5 of ‘283 claims the compound of claim 3 wherein R1 and R2 connect to form a five-membered, six-membered, seven-membered, or eight-membered ring. Claim 10 is directed to a pharmaceutical composition comprising the compound according to claim 1 and a pharmaceutically acceptable carrier, adjuvant, or excipient.
The claims are not identical but are not patentably distinct because the compounds of Claim 5 read on the species of the examined application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 2, 4, 16, 33 and 34 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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/P.M.R./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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