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 .
Status of the Claims and Response to Restriction Requirement
Claims 1-9, 11-18, 21-25, 27 and 29-31 are pending as of the response filed 05/22/2026. Claims 10,19-20, 26 and 28 are cancelled. Claims 29-31 are newly added. Applicant’s election of group I claims, is acknowledged. Claims 27 and 29-31 (the newly added claims read on group II claims) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election of a species of compound shown below is acknowledged.
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Claims 1-5, 11, 14-17, 21-22 and 24-25 encompass the elected species. Claims 6-9, 12-13, 18 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 1-5, 11, 14-17, 21-22 and 24-25 have been examined to the extent to which they are readable on the above identified elected species.
The examiner acknowledges that in the event the elected species is found allowable, examination will be extended to non-elected species, in accordance with MPEP § 803.02 (III).
Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement/election of species requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The elected species was examined and found to be free of prior art. Therefore, the examiner has extended the search to include the following species of compounds that render the compounds of formula (I) as in claim 1 anticipated.
In view of the pending claims, the following rejections are made as discussed below.
Priority
This application is a 371 of PCT/GB2022/051667 filed 06/29/2022 and claims foreign priority to UNITED KINGDOM 2109324.0 filed 06/29/2021 and UNITED KINGDOM 2208160.8 filed 06/01/2022.
The subject matter of claims 1-5, 11, 14-17, 21-22 and 24-25 are supported by the foreign priority applications and accordingly, have an effective filing date of 06/29/2021.
Information Disclosure Statement
The information disclosure statements submitted on 08/09/2024, 07/05/2024, 04/02/2024, 03/06/2024, 02/16/2024 and 01/25/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 21-22 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dai et al. (US 9,957,362 B2, 01 May 2018, hereinafter Dai, in the IDS).
Regarding instant claim 1, Dai teaches compounds of formula (I) and pharmaceutically acceptable salts thereof, with variables as defined and pharmaceutical compositions thereof (Abstract; Col. 2, Ln. 1 - Col. 5, Ln. 4).
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Dai teaches an exemplary compound, 4-[2-(2,6-dimethylphenoxy)-5-(methylsulfonyl)phenyl]-6-methyl-2-[3-(tetrahydro-2H-pyran-4-yl)-1,2,4-oxadiazol-5-yl]-1,6-dihydro-7H-pyrrolo[2,3-c]pyridin-7-one, having the following structure (Col. 30, Lns. 48-50).
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The compound of Dai falls within the scope of formula (I) of instant claim 1, wherein
Ring A is phenyl;
X4 is carbon;
X5 is carbon;
R1 is C1-C3 alkyl (methyl);
R2 is a 5-membered heterocyclyl (oxadiazolyl) substituted with 1 R2a, R2a being a 6-membered heterocyclyl (tetrahydropyranyl);
R3 is OR3b, R3b being C0-C3-alkylene-R3d, R3d being phenyl substituted with 2 R9, each R9 being C1-C4 alkyl (methyl);
m is 1;
R4 is C0-C4-alkylene-S(O)2R6, R6 being C1-C4 alkyl (methyl);
Rx is H;
Ry is H.
The above compound further reads on the limitations of instant claims 2-5, 21-22. Dai teaches pharmaceutical compositions comprising a therapeutically effective amount of a compound of formula (I), or a pharmaceutically acceptable salt thereof together with a pharmaceutically acceptable carrier, diluent, or excipient therefor (Col. 42, Lns. 40-44).
Therefore, Dai anticipates the limitations of instant claims 1-5, 21-22 and 25.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 11, 21-22 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (WO 2013/097052 A1, 04 July 2013, hereinafter Wang, in the IDS).
Regarding instant claim 1, Wang teaches bromodomain inhibitor compounds of formula (I) and pharmaceutically acceptable salts thereof, with variables as defined and pharmaceutical compositions thereof (Abstract; Pg. 1, Ln. 27 - Pg. 4, Ln. 22).
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Wang teaches an exemplary compound, 6-methyl-4-(2-phenoxyphenyl)-2-phenyl-1,6-dihydro-7H-pyrrolo[2,3-c]pyridin-7-one, having the following structure (Pg. 26, Ln. 7).
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The compound of Wang falls within the scope of formula (I) of instant claim 1, wherein
Ring A is phenyl;
X4 is carbon;
X5 is carbon;
R1 is C1-C3 alkyl (methyl);
R2 is phenyl;
R3 is OR3b, R3b being C0-C3-alkylene-R3d, R3d being phenyl;
m is 0;
Rx is H;
Ry is H.
The above compound of Wang further reads on the limitations of instant claims 2-5, 11 (wherein n13 is 0), 21-22. Wang teaches pharmaceutical compositions comprising a therapeutically effective amount of a compound of Formula I, or a pharmaceutically acceptable salt thereof together with a pharmaceutically acceptable carrier, diluent, or excipient therefor (Pg. 36, Lns. 19-22). Therefore, Wang anticipates the limitations of instant claims 1-5, 11, 21-22 and 25.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, 11, 14-17, 21-22 and 24-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7-15 and 17-18 of co-pending Application No 19/140,608.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compounds having similar core structures.
The instant claims are drawn to a compound of formula (I) or a pharmaceutically acceptable salt or N-oxide thereof, and a pharmaceutical composition thereof, with variables as defined in instant claim 1.
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The claims of the reference co-pending ‘608 application are drawn to a compound of formula (XI) or a pharmaceutically acceptable salt or N-oxide thereof, and a pharmaceutical composition thereof, with variables as defined in claim 1 of the reference application.
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The following compound of claim 17 of the reference ‘608 application,
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anticipates instant claim 1 wherein,
Ring A is pyridone;
X4 is carbon;
X5 is carbon;
R1 is C1-C3 alkyl (methyl);
R2 is phenyl substituted with two R2a, R2a is independently selected to be halo (fluoro) and C1-C4 alkyl (methyl);
R3 is OR3b, R3b being C0-C3-alkylene-R3d, R3d being phenyl substituted with 2 R9, each R9 is independently selected from C1-C4 alkyl (methyl);
m is 1, R4 is C1-C4 alkyl (methyl);
Rx is H;
Ry is H.
The above compound anticipates the limitations of instant claims 1-5, 11, 14-17, 21-22. The pharmaceutical composition of claim 18 of the reference ‘608 application anticipates the composition of instant claim 25.
The above compound is a positional isomer of the instantly elected species of compound, recited in instant claim 24. Looking into the specification of the reference ‘608 application for utility of the compounds, the compounds of the reference application are taught to be BET protein inhibitors (Para. [0029]). The instant compounds are taught to be BET protein inhibitors (Para. [0011] of the instant specification).
According to MPEP 2144.09 (I), “A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).” In the instant case, the compounds of the reference application have close structural similarity to the instant compounds and have the same utility (BET protein inhibitors), rendering the instant compound of claim 24 prima facie obvious.
Thus, claims 1, 3, 7-15 and 17-18 of the reference co-pending ‘608 application and instant claims 1-5, 11, 14-17, 21-22 and 24-25 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5, 11, 14-17, 21-22 and 24-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7-15 and 17-18 of co-pending Application No 19/677,944.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compounds having similar core structures.
The instant claims are drawn to a compound of formula (I) or a pharmaceutically acceptable salt or N-oxide thereof, and a pharmaceutical composition thereof, with variables as defined in instant claim 1.
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The claims of the reference co-pending ‘944 application are drawn to a compound of formula (XI) or a pharmaceutically acceptable salt or N-oxide thereof, and a pharmaceutical composition thereof, with variables as defined in claim 1 of the reference application.
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The following compound of claim 17 of the reference ‘944 application,
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anticipates instant claim 1 wherein,
Ring A is pyridone;
X4 is carbon;
X5 is carbon;
R1 is C1-C3 alkyl (methyl);
R2 is phenyl substituted with two R2a, R2a is independently selected to be halo (fluoro) and C1-C4 alkyl (methyl);
R3 is OR3b, R3b being C0-C3-alkylene-R3d, R3d being phenyl substituted with 2 R9, each R9 is independently selected from C1-C4 alkyl (methyl);
m is 1, R4 is C1-C4 alkyl (methyl);
Rx is H;
Ry is H.
The above compound anticipates the limitations of instant claims 1-5, 11, 14-17, 21-22. The pharmaceutical composition of claim 18 of the reference ‘944 application anticipates the composition of instant claim 25.
The above compound is a positional isomer of the instantly elected species of compound, recited in instant claim 24. Looking into the specification of the reference ‘944 application for utility of the compounds, the compounds of the reference application are taught to be BET protein inhibitors (Para. [0029]). The instant compounds are taught to be BET protein inhibitors (Para. [0011] of the instant specification).
According to MPEP 2144.09 (I), “A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).” In the instant case, the compounds of the reference application have close structural similarity to the instant compounds and have the same utility (BET protein inhibitors), rendering the instant compound of claim 24 prima facie obvious.
Thus, claims 1, 3, 7-15 and 17-18 of the reference co-pending ‘944 application and instant claims 1-5, 11, 14-17, 21-22 and 24-25 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-5, 11, 14-17, 21-22 and 24-25 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached 9:00-5:30pm EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PADMAJA S RAO/Examiner, Art Unit 1627
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