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 .
Current Status
This action is responsive to the amended claims of 12/04/2025. Claims 1 and 318-341 are pending. Claims 319-328, 330, 333-337, and 339-341 are withdrawn. Claims 1, 318, 329, 331-332, and 338 have been examined on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1 and 318-338) and compound no. 275
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in the reply filed on 12/04/2025 is acknowledged.
A search for compound no. 275 did not return any prior art (see SEARCH 6 of the attached search notes). Thus, the Markush search has been extended to the following species:
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and
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.
The extended species read on claims 1, 318, 329, 331-332, and 338.
Claims 319-328, 330, and 333-337 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of Formula I, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/04/2025.
Claims 339-341 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/04/2025.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 10/13/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/12/2023, 03/25/2024, and 12/04/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1, 318, 329, 331-332, and 338 are objected to because of the following informalities. Appropriate correction is required.
Claim 1 recites “the ring including B5A, B5B, B6A, B6B, and B6C is heteroaryl” on Pg. 6 line 6-7. The use of “including” is objected to. While it is clear that the “ring including” the B moieties is ring B Formula (B-III), it is preferred if Applicant use more explicit language here, such as: “the ring containing B5A, B5B, B6A, B6B, and B6C is heteroaryl”. Dependent claims 318, 329, 331-332, and 338 are similarly objected to since they do not rectify the underlying issue.
Claim 1 recites “ach R1 is selected from” on Pg. 6 line 15; please address the typographical error by replacing “ach” with “each”. Dependent claims 318, 329, 331-332, and 338 are similarly objected to since they do not rectify the underlying issue.
Note: withdrawn claims 327-328 and 336-337 would be objected to for the following reasons if not withdrawn:
Claims 327 and 328 further limit variables B7, B8, and Raa which are exclusive to ring B formulas (B-IV) and (B-V). However, these claims do not require ring B to be either of these formulas. If Applicant intends for the claim to limit the ring B to either formula (B-IV) or (B-V), it is recommended Applicant explicitly state ring B is chosen from Formula (B-IV) or (B-V) in both claims.
Claims 336-337 recites structures of compounds of Formula (I); however, many of the structures contain overlapping atoms/bonds making the structures difficult to read; e.g., compound 104
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. Please provide new structures wherein the alignment of all elements is improved. Due to the quantity of disclosed compound structures, Applicant is asked to review all structures of claims 336-337.
Claim Rejections - 35 USC § 112
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.
Claims 1, 318, 329, 331-332, and 338 are 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.
Claim 1 recites “Rz1 and Rz2 taken together with the phosphorous atom to which each is attached forms a ring including from 5-8 ring atoms” on Pg. 3 final paragraph. The use of “including from” to define the number of ring atoms is ambiguous. It is unclear if the ring is required to have only 5-8 ring atoms or if the ring has to include at least 5-8 atoms (e.g., a ring with 10 ring atoms includes 5, 6, 7, and 8 ring atoms). Thus, the metes and bounds of the claim are undefined rendering the claim indefinite. Dependent claims 318, 329, 331-332, and 338 are similarly rejected since they do not rectify the underlying issue.
To overcome: Applicant may consider amending as follows: -- Rz1 and Rz2 taken together with the phosphorous atom to which each is attached forms a ring having 5-8 ring atoms -- .
Claim 1 recites “(in addition to the phosphorous attached to Rz1 and Rz2)” on Pg. 3 last two lines. Since the recited limitation is enclosed by a set of parentheses, it is unclear whether the limitation is required by the claim or if it is merely exemplary. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite. Dependent claims 318, 329, 331-332, and 338 are similarly rejected since they do not rectify the underlying issue.
To overcome: Applicant may strike the parentheses from the recited limitation. In general, parentheses should only be used around acronyms and within chemical names/formulas.
Claim 1 recites wherein Rv is selected from “-N(Rs)2 3- to 8- membered heterocycloalkyl” on Pg. 4 line 9. It is unclear if the recited limitation is meant to recite two separate instances of Rv (i.e., -N(Rs)2 and 3- to 8- membered heterocycloalkyl) or one instance of Rv (i.e., -N(Rs)2 further bound to a 3- to 8- membered heterocycloalkyl). Thus, the metes and bounds of the claim are undefined rendering the claim indefinite. Dependent claims 318, 329, 331-332, and 338 are similarly rejected since they do not rectify the underlying issue.
To overcome: Based on exemplary compounds, Examiner understands these as two instances of Rv. If this is correct, please amend by adding a comma between the two moieties: “-N(Rs)2, 3- to 8- membered heterocycloalkyl”.
Claim 1 recites wherein Rv is selected from “(C1-C6)alkenyl” on Pg. 4 line 11. The moiety C1 alkenyl is chemically impossible; an alkene requires at least two carbon atoms. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite. Dependent claims 318, 329, 331-332, and 338 are similarly rejected since they do not rectify the underlying issue.
To overcome: Please replace the recited limitation with “(C2-C6)alkenyl”.
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 (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 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, 318, 329, 331-332, and 338 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CHEN (WO 2011/068821; provided in IDS of 04/12/2023).
Regarding claim 1, CHEN teaches compound
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(Pg. 35 Table Row 5 & Pg. 191 claim 9) wherein X1, X5, X6, X7, X8 are CH; X3 is C; X2 and X4 are N wherein at least two and no more than four of the X1-X8 are N; T1 is T3 wherein T3 is 6-membered heteroaryl substituted with 1 Rv wherein Rv is -N(Rs)2 wherein Rs is H; T2 is C4 alkyl; L1 and L2 are a bond; ring A is phenylene substituted with 1 RY wherein RY is CN; L3 is a bond; ring B is formula (B-III) wherein B6A, B5B, and B6B are N, B5A is C, and B6C is CR1 wherein R1 is H; in ring B at least one of the B variables is a heteroatom, at least one B variable is a C or CR1, and the ring B is a heteroaryl; L4 is a bond; ring C is phenyl; b is 1; and Rb is halogen (Cl).
Regarding claim 318, the compound of CHEN has the moiety
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.
Regarding claim 329, the compound of CHEN teaches L4 is a bond.
Regarding claims 331-332, the compound of CHEN teaches ring C is phenyl.
Regarding claim 338, CHEN further teaches a pharmaceutical composition comprising a compound of the invention (including the above compound) and a pharmaceutically acceptable excipient and/or carrier (Pg. 192 claim 10).
Further regarding claims 1, 318, 329, and 338, CHEN teaches another compound
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(Pg. 19 Table row 2 & Pg. 187 claim 9) wherein X1, X5, X6, X7, X8 are CH; X3 is C; X2 and X4 are N wherein at least two and no more than four of the X1-X8 are N; T1 is T3 wherein T3 is 6-membered heteroaryl substituted with 1 Rv wherein Rv is -N(Rs)2 wherein Rs is H; T2 is C4 alkyl; L1 and L2 are a bond; ring A is phenylene; L3 is a bond; ring B is formula (B-III) wherein B6A and B6B are N, B5A and B5B are C, and B6C is O; in ring B at least one of the B variables is a heteroatom, at least one B variable is a C or CR1, and the ring B is a heteroaryl; L4 is a bond; ring C is C3 cycloalkyl; and b is 0 therefore Rb is not present. CHEN further teaches a pharmaceutical composition comprising the compound and a pharmaceutically acceptable excipient and/or carrier (Pg. 192 claim 10).
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, 318, 329, 331-332, and 338 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/856,543 (reference application – claims of 10-11-2024). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 1 recites many compounds, all of which fall under the instant Formula (I) of instant claim 1. For example,
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wherein X1, X5, X7, X8 are CH; X6 is CRw wherein Rw is halogen (F); X3 is C; X2 and X4 are N wherein at least two and no more than four of the X1-X8 are N; T1 is T3 wherein T3 is C(=O)(OH); T2 is
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; L1 is C1 alkyl; L2 is a bond; ring A is
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wherein W1 is N and W2 is CRY2 wherein RY2 is H; L3 is a bond; ring B is formula (B-IV) or (B-V); B10-B12 and B9 are CR1 and C(Raa) respectively, wherein R1 is H and Raa is H; B7-B8 are O; L4 is a bond; ring C is phenyl; b is 2; and Rb is halogen (F & Cl). This exemplary compound reads on at least the instantly examined claims 1, 318, 329, 331-332, and 338. The other compounds of reference claim 1 map to instant Formula (I) if the moieties of the reference compounds are mapped to the instant formula in the following manner:
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. Reference claim 2 is drawn to a pharmaceutical composition thereof comprising a pharmaceutically acceptable excipient. Reference claims 3-9 teach a method of use thereof. To practice the method the artisan would have to be in possession of the compound. Thus, since reference claim 1 is drawn to a series of compounds which are species of the instant Formula (I), the reference claims anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 318, 329, 331-332, and 338 are rejected.
Note: document WO 2022042691 (provided in IDS of 03/25/2024) was retrieved incidental to the search for the elected/expanded species above. WO ‘691 shares inventors and the applicant with the instant application; however, it is by another so it was briefly considered as prior art. WO ‘691 teaches one compound
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(Pg. 60 compound 141) which is analogous to instant Formula (I). The compound 141 differs from the instant in that ring B does not fall under any of instant formulas (B-I)-(B-V). Further, WO ‘691 was published 03 March 2022 (i.e., after the instant EFD) and the CN priority document (filed 28 August 2020, i.e., before the instant EFD) does not disclose the above compound 141. Thus, WO ‘691 compound 141 cannot be considered prior art against the instant claims.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625