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
Claims 1-7, 11, 15, 54, 91, 98-100 and 104 are pending. Claims 99 and 100 are withdrawn. Claims 1-7, 11, 15, 54, 91, 98, and 104 are rejected.
Election/Restrictions
Applicant’s election of Group I and the species Example 60:
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, in the reply filed on 5/6/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-7, 11, 15, 54, 91, 98, and 104 embrace Applicant’s elected species and are therefore under examination. The elected species is not allowable. The elected species is free of the prior art, but rejected below under double patenting. Non-elected species have been discovered incidental to the search of the elected species and are presented below in the interest of compact prosecution.
Claims 99 and 100 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 1-7, 11, 15, 54, 91, 98, and 104 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, p. 6, line 25 recites a “moiety Q” wherein there is no other corresponding variable “Q” within claim 1 or Formula (I). L1 is more clearly a linker between “Ring B” and variable “E”. It is unclear if Applicant intended Formula (I) to have a corresponding “moiety Q”. Examiner recommends changing “moiety Q” to “Ring B” in claim 1, p. 6, line 25. Claims 4-7, 11, 15, 54, 91, 98, and 104 are additional rejected for depending from claim 1 and failing to remedy the deficiencies.
Claim 2, p. 11, line 18 recites a “moiety Q” wherein there is no other corresponding variable “Q” within claim 2 or Formula (I). L1 is more clearly a linker between “Ring B” and variable “E”. It is unclear if Applicant intended Formula (I) to have a corresponding “moiety Q”. Examiner recommends changing “moiety Q” to “Ring B” in claim 2, p. 11, line 18.
Claim 3, p. 16, line 10 recites a “moiety Q” wherein there is no other corresponding variable “Q” within claim 3 or Formula (I). L1 is more clearly a linker between “Ring B” and variable “E”. It is unclear if Applicant intended Formula (I) to have a corresponding “moiety Q”. Examiner recommends changing “moiety Q” to “Ring B” in claim 3, p. 16, line 10.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7, 11, 15, 54, 91, and 104 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schenkel et al (WO2020257416).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Schenkel teaches quinazolinones and related compounds which degrade PARP14 and are useful in the treatment of cancer and inflammatory diseases (see abstract). Schenkel discloses the following genus in claim 1:
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. Schenkel specifically teaches the following compounds/species in claim 53
(EXAMINER is calling this compound “53a”.):
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(EXAMINER is calling this compound “53c”.):
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and the following pharmaceutical compositions in claim 54:
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.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art differs from the instant claims in the placement of the “L1-E” moiety. Additional dependent limitations will be addressed below.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 1-6, 11, 15, 54, 91, and 104, the prior art compound (“53a” supra) is similar to a compound of instant Formula (I):
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, wherein Ring A = 6 membered heterocycloalkyl:
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; Y2 = -S-; R1 and R2 = H; W = -C-F; X and Z = -CH; Y1 = -NH-, R3 = H; m = 0; Ring B = 5 membered cycloalkyl:
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; L1 =
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(embraced by the following of instant claim 54:
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, wherein a = 1, G1 =
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, b = 1; c = 0; d = 1; G3 = -NH-, e = 1; f =0); E =
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. Regarding the alternative placement of the “L1-E” moiety, the prior art compound and a compound of the instant claims are considered positional (and constitutional) isomers. “ ‘Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.’ In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).” See MPEP 2144.09(II). The prior art compound and the instantly claimed compound are both PARP14 degraders. It would have been obvious to arrive at the instantly claimed compounds, which are positional isomers with identical function of the prior art compound, with a reasonable expectation of success in a useful compound and pharmaceutical composition.
Regarding instant claim 7, the prior art compound (“53c” supra) is similar to a compound of the instant claims, wherein Y1 = -O- and is a positional isomer. It would have been obvious to a PHOSITA to arrive at the positional isomer of instant claim 7 for the same reasons as mentioned supra.
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.
(1 of 3) Claims 1-7, 11, 15, 54, 91, 98, and 104 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 -115 of copending Application No. 19445156 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1-7, 11, 15, 54, 91, 98, co-pending application 19445156 is drawn to product and methods (the instant claims are only drawn to products) and teach the following genus (claim 1):
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(identical variable placement to instant claims) and species (claim 101, top of p. 35, which is identical to applicant’s instant elected species):
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, drawn to the following structure:
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, as a PARP14 degrader (see title). The co-pending species drawn above is embraced by a compound of instant formula (I) wherein Ring A =
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; Y2 = -S-; R1, R2, R6 and R7 = H; W = C-F; X and Z = -CH; Y1 = -O-; m = 1; Ring B =
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; L1 =
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; E =
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.
Regarding instant claim 104, the copending application teaches the following in claim 104 also:
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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(2 of 3) Claims 1-7, 11, 15, 54, 91, and 104 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 12-13, 19-24, 70-78 and 80 of copending Application No. 18227643 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1-7, 11, 15, 54, and 91, the copending application teaches the following genus (claim 1), which has the “L1-E” moiety in a different position from the instant genus of formula (I):
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and the following species (claim 78, second from bottom on p. 21):
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, drawn to the following structure:
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, wherein Ring A =
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; Y2 = -S-; R1, R2, R6, and R7 = H; W = C-F; X and Z = -CH; Y1 = O; Ring B =
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; L1 =
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; E =
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. Regarding the co-pending application teaching positional isomers, it would have been obvious to a skilled artisan to arrive at the instant claims with a reasonable expectation of success. “ ‘Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.’ In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).” See MPEP 2144.09(II). The co-pending compound and the instantly claimed compound are both PARP14 degraders.
Regarding instant claim 104, the copending case teaches the following in claim 80:
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(3 of 3) Claims 1-7, 11, 15, 54, 91, and 104 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8, 45-54 and 56 of copending Application No. 19216120 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1-7, 11, 15, 54, and 91, the copending case discloses the following genus in claim 1:
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. The copending case specifically teaches the following compounds/species in claim 53
(EXAMINER is calling this compound “53a”.):
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(EXAMINER is calling this compound “53c”.):
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and the following pharmaceutical compositions in claim 54:
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Regarding instant claims 1-6, 11, 15, 54, 91, and 104, the copending case compound (“53a” supra) is similar to a compound of instant Formula (I):
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, wherein Ring A = 6 membered heterocycloalkyl:
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; Y2 = -S-; R1 and R2 = H; W = -C-F; X and Z = -CH; Y1 = -NH-, R3 = H; m = 0; Ring B = 5 membered cycloalkyl:
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; L1 =
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(embraced by the following of instant claim 54:
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, wherein a = 1, G1 =
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, b = 1; c = 0; d = 1; G3 = -NH-, e = 1; f =0); E =
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. Regarding the alternative placement of the “L1-E” moiety, the copending case compound and a compound of the instant claims are considered positional (and constitutional) isomers. “ ‘Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.’ In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).” See MPEP 2144.09(II). The prior art compound and the instantly claimed compound are both PARP14 degraders. It would have been obvious to arrive at the instantly claimed compounds, which are positional isomers with identical function of the copending case compound, with a reasonable expectation of success in a useful compound and pharmaceutical composition.
Regarding instant claim 7, the copending compound (“53c” supra) is similar to a compound of the instant claims, wherein Y1 = -O- and is a positional isomer. It would have been obvious to a PHOSITA to arrive at the positional isomer of instant claim 7 for the same reasons as mentioned supra.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
Prosecution Insights