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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/9/2026 has been entered.
Status of the Claims
Claims 1, 3-7, and 9-17 are pending. Claims 9-14 and 17 are withdrawn. Claims 1, 3-7 and 15-16 are rejected.
Election/Restrictions
Applicant’s election without traverse of Group I and the following species:
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, in the reply filed on 4/23/2025 is acknowledged.
Since claims 1, 3-7 and 15-16 embrace Applicant’s elected species, these claims are under examination.
The elected species is not allowable; the elected species is free of the prior art but it has been rejected under double patenting below. Incidental to the search of the elected species, prior art over non-elected species was discovered and, in the interest of compact prosecution, is presented below. Additionally, claim 15 has been searched in full and while rejected under double patenting, is free of the prior art.
Claims 9-14 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Response to Amendments/Arguments
Applicant’s arguments and amendments, filed 1/9/2026, with respect to the rejection(s) and objections of claim(s) 1-7 and 15-16 under Improper Markush, 35 USC 112(d), 102, 103 and double patenting have been fully considered and are persuasive. Specifically:
Amendments overcame objection to claim 15.
Amendments overcame 112(d) rejection to claim 7.
Claim 2 was cancelled by amendments.
Amendments overcame the improper Markush rejection of claims 1 and 16.
Declaration under 37 CFR 1.130a has overcome the 35 USC 102 and 103 rejections of claims 1-7 and 15-16 specifically over WO2019/040573.
Terminal Disclaimer over US11365206 overcame the double patenting rejection of claims 1-7 and 15-16, specifically over this patent.
Therefore, the rejections mailed by the Office on 10/10/2025 have been withdrawn and arguments will not be addressed. However, upon further consideration for the RCE and in view of 1/9/2026 amendments, new ground(s) of rejection have been made below.
Claim Objections
Claim 1 is objected to because of the following informalities:
On p. 3: Rd definition includes both “=O” and “oxo”, which are identical and repetitive;
On p. 4: Re definition includes both “=O” and “oxo”, which are identical and repetitive;
Appropriate correction is required.
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.
Claim 4 is 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.
On p. 7 of claim 4 is shown the following (arrows added by Examiner) for Formula (A-3):
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. There is no clear dashed bond, as indicated there should be by the bottom arrow. Formula (A-3) on instant specification p. 11 shows the follow (arrow added again by Examiner):
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, which clearly has a dashed line in the location of the arrow. In the interest of compact prosecution, Examiner is interpreting the location of the top arrow(s) to be the dashed line, as indicated by the figure shown supra from the instant specification. Examiner recommends amending the claims so that Formula (A-3) matches that from the specification, with the dashed line clearly drawn (in the Q5 ring location).
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 3-7 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 2290611-38-8 (which entered the STN database on 3/20/2019).
Regarding instant claims 1 and 3, CAS Registry No. 2290611-38-8 is drawn to the following structure:
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, which is embraced by a tautomer of instant Formula (A-1):
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, wherein R9 = R9A= heterocycloalkyl:
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; L= -L1-L2-, L1 = bond, L2 = alkyl; Z1 = N(H); Q7 = 6 membered aryl:
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; W= O; g = 0; R8 = nitro; k = 1; Q1 = 7 membered heterocycloalkyl; Q2 = 6 membered heteroaryl; two R11 combine to form a heteroaryl; R10 = alkyl (-CH3); j = 0; Q5 = 6 membered heterocycloalkyl:
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; s = 1; R3, R4 = H; n = 2; R2 = alkyl; Q4 = heterocycloalkenyl:
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; m = 1; R1 = halo (Cl). Regarding instant claim 4, W1 and W2= N and the dashed bond is absent (single bond) on Q5 (see 112b supra). Regarding instant claims 5 and 6, W1= N. Regarding instant claim 7,
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is
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, specifically:
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, wherein Z2 = -O-; f = 1; other variables described supra.
Regarding instant claim 16, which is drawn to a composition comprising the compound or tautomer in a pharmaceutically acceptable carrier, the CAS Registry entry includes predicted properties including mass and molar solubilities at varying pH values. MPEP 2131.02(III) states:
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015).
In this situation, a person having ordinary skill in the art in viewing the properties of the Registry entry would at once envisage a composition with the tautomer and water, which is a pharmaceutically acceptable carrier. For example, the mass solubility of 0.00000029 g/L (at pH 9) would convey to a PHOSITA a composition comprising 0.00000029 grams of the tautomer above in 1L of water.
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 9) Claims 1, 3-7, and 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12220419. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1, 3-7 and 15, US12220419 teaches the following genus in claim 1 as BCL-2 inhibitors:
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and the following species in claim 27 (see column 402, 4th structure down):
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, which is drawn to the following structure (arrow added by Examiner):
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, which is similar to the second structure from the bottom of p. 14 in instant claim 15. The prior art tautomer differs from the instantly claimed compound in claim 15:
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, by the lack of one methyl group at the position of the added arrow. The compounds as taught by the patent and the compounds/tautomers in the instant claims are considered structural analogs and hydrogen and methyl are deemed obvious variants. It is well established that the substitution of hydrogen for methyl on a known compound is not a patentable modification absent unexpected or unobvious results. In re Wood, Whittaker, Stirling, and Ohta, 582 F.2d 638, 199 U.S.P.Q 137 (C.C.P.A. 1978). In the instant case, a person having ordinary skill in the art at the time the invention was filed would have been motivated to synthesize the instantly claimed analogs with the reasonable expectation that it would have the same utility as the closest structurally related compounds taught by the patent and with the motivation of obtaining additional useful compounds. A person of ordinary skill in the art would have expected them to be useful in the same utilities and been motivated to apply them in the same methods. Additionally, the compounds of the patent are drawn to BCL-2 inhibitors, as are those instantly claimed.
Specifically regarding instant claims 1 and 3, the prior art compound is embraced by a tautomer of instant formulas (A-1):
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and (A-2):
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, wherein R9 = R9B =
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; L = -L1-L2- = bond and alkyl; Z1 = NH; Q7 = 6 membered aryl; g = 0; R8 = nitro; W= O; Q1 and Q2 =
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; j = 0; Q5 =
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, s = 1, R3 and R4 = H; Q4 =
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; R1 = Cl. Regarding instant claims 4-6, the dashed line is a single bond and W1, W2 =N. Regarding instant claim 7, Z2 = O and f = 1.
Regarding instant claim 16, US1220419 teaches the following in claim 28:
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.
Regarding instant claims 1, 3-7 and 15-16, it would have been obvious to a skilled artisan to arrive at the instant claims from the species of the patent shown supra, with the analogous function of inhibiting BCL-2. The compound is a lead compound, as claimed, and is a representation of both the patent genus and the instant claims genus. A PHOSITA would have been motivated to select identical species, embraced by both the patent and the instant claims/genus, with a reasonable expectation of success in inhibiting BCL-2.
(2 of 9) Claims 1, 3-7, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11903950. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim 1, US11903950 claim 1 teaches the following genus as BCL-2 inhibitors:
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and particularly the following compound in claim 23 (first compound listed), which is drawn to the following structure:
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. Regarding instant claims 1 and 3, said compound is embraced by a compound of instant formulas (A-1):
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and (A-2):
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, wherein R9 = R9A=
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; L = bond and alkyl; Z1 = N(H); g = 0; Q7 = 6 membered aryl; R8 = nitro; W = O; Q1 and Q2 =
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; Q5=
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; s = 1; R3 and R4 = H; Q4 =
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; R1 = Cl. Regarding instant claims 4-6, dashed line is a single bond and W1 and W2 = N. Regarding instant claim 7, Z2 = S and f = 0. Regarding instant claim 16, the patent teaches the following in claim 24:
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.
Regarding instant claims 1, 3-7 and 16, it would have been obvious to a skilled artisan to arrive at the instant claims from the species of the patent shown supra, with the analogous function of inhibiting BCL-2. The compound is a lead compound, as claimed, and is a representation of both the patent genus and the instant claims genus. A PHOSITA would have been motivated to select identical species, embraced by both the patent and the instant claims/genus, with a reasonable expectation of success in inhibiting BCL-2.
(3 of 9) Claims 1, 3-7 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12410190. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1 and 3, the patent teaches the following compound as the first compound in claim 1 as a BCL-2 inhibitor, drawn to the following structure:
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, which is embraced by a compound of instant formulas (A-1):
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and (A-2):
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, wherein R9 = R9A=
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; L = bond and alkyl; Z1 = N(H); g = 0; Q7 = 6 membered aryl; R8 = nitro, W = O; Q1 and Q2 =
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; j = 0; Q5=
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; s = 1; R3 and R4 = H; Q4 =
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; R1 = Cl. Regarding instant claims 4-6, dashed line is a single bond and W1 and W2 = N. Regarding instant claim 7, Z2 = O and f = 0. Regarding instant claim 16, the patent teaches the following in claim 7:
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.
Regarding instant claims 1, 3-7 and 16, it would have been obvious to a skilled artisan to arrive at the instant claims from the species of the patent shown supra, with the analogous function of inhibiting BCL-2. The compound is a lead compound, as claimed, and is embraced by the instant claims genus. A PHOSITA would have been motivated to select identical species, embraced by both the patent and the instant claims/genus, with a reasonable expectation of success in inhibiting BCL-2.
(4 of 9) Claims 1, 3-7 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11680072. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1 and 3, the patent teaches the following compound in claim 2 as a BCL-2 inhibitor, drawn to the following structure:
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, which is embraced by a compound of instant formulas (A-1):
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and (A-2):
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, wherein R9 = R9A=
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; L = bond and alkyl; Z1 = N(H); g = 0; Q7 = 6 membered aryl; R8 = nitro, W = O; Q1 and Q2 =
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; j = 0; Q5=
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; s = 1; R3 and R4 = H; Q4 =
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; R1 = Cl. Regarding instant claims 4-6, dashed line is a single bond and W1 and W2 = N. Regarding instant claim 7, Z2 = O and f = 0. Regarding instant claim 16, the patent teaches the following in claim 3:
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.
Regarding instant claims 1, 3-7 and 16, it would have been obvious to a skilled artisan to arrive at the instant claims from the species of the patent shown supra, with the analogous function of inhibiting BCL-2. The compound is a lead compound, as claimed, and is embraced by the instant claims genus. A PHOSITA would have been motivated to select identical species, embraced by both the patent and the instant claims/genus, with a reasonable expectation of success in inhibiting BCL-2.
(5 of 9) Claims 1, 3-7 and 16 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11279711. Although the claims at issue are not identical, they are not patentably distinct from each other.
The patent teaches the following genus in claim 1:
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, as a BCL-2 inhibitor. Regarding instant claims 1 and 3, US11279711 teaches the following as the first compound of claim 15, drawn to the following structure:
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which is embraced by a compound of instant formulas (A-1):
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and (A-2):
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, wherein R9 = R9A =
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; L = bond and alkyl; Z1 = N(H); Q7 = 6-membered aryl; g = 0; R8 = nitro; W = O; Q1 and Q2 =
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; Q5 =
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; s = 1, R3 and R4 = H; Q4 =
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; R1 = Cl. Regarding instant claims 4-6, dashed line is a single bond and W1 and W2 = N. Regarding instant claim 7, Z2 = O and f = 1. Regarding instant claim 16, the patent teaches the following in claim 16:
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.
Regarding instant claims 1, 3-7 and 16, it would have been obvious to a skilled artisan to arrive at the instant claims from the species of the patent shown supra, with the analogous function of inhibiting BCL-2. The compound is a lead compound, as claimed, and is a representation of both the patent genus and the instant claims genus. A PHOSITA would have been motivated to select identical species, embraced by both the patent and the instant claims/genus, with a reasonable expectation of success in inhibiting BCL-2.
(6 of 9) Claims 1, 3-7 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19027649 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The co-pending application teaches the following genus in claim 1, as BCL-2 inhibitors:
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. Regarding instant claims 1 and 3, the co-pending case specifically lists the following species as the first compound of claim 15, drawn to the following structure:
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which is embraced by a compound of instant formulas (A-1):
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and (A-2):
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, wherein R9 = R9A=
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; L = bond and alkyl; Z1 = N(H); Q7 = 6 membered aryl; g = 0; R8 = nitro; W = O, Q1 and Q2 =
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; Q5 =
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; s = 1, R3 and R4 = H; Q4 =
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; R1 = Cl. Regarding instant claims 4-6, dashed line is a single bond and W1 and W2 = N. Regarding instant claim 7, Z2 = O and f = 0. Regarding instant claim 16, the copending case teaches the following in claim 16:
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.
Regarding instant claims 1, 3-7 and 16, it would have been obvious to a skilled artisan to arrive at the instant claims from the species of the copending case shown supra, with the analogous function of inhibiting BCL-2. The compound is a lead compound, as claimed, and is a representation of both the copending case genus and the instant claims genus. A PHOSITA would have been motivated to select identical species, embraced by both the copending case and the instant claims/genus, with a reasonable expectation of success in inhibiting BCL-2.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(7 of 9) Claims 1, 3-7 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 7, 9, 12, 19-21, 26, 41, and 50-61 of copending Application No. 17798904 in view of Birtalan et al. (US20120108590).
In claim 1, the co-pending application teaches the following genus as a BCL2 inhibitor, in solid dispersion form:
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. Regarding instant claims 1 and 3, the copending case discloses the following compound as the first compound listed in claim 5, drawn to the following structure:
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which is embraced by a compound of instant formulas (A-1):
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and (A-2):
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, wherein R9 = R9A=
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; L = bond and alkyl; Z1 = N(H); Q7 = 6 membered aryl; g = 0; R8 = nitro; W = O, Q1 and Q2 =
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; Q5 =
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; s = 1, R3 and R4 = H; Q4 =
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; R1 = Cl. Regarding instant claims 4-6, dashed line is a single bond and W1 and W2 = N. Regarding instant claim 7, Z2 = O and f = 0. Regarding instant claim 16, the copending case teaches the solid dispersion containing surfactants, which are pharmaceutically acceptable carriers.
The instant claims differ from those of the co-pending case in that the instant claims are not drawn specifically to solid dispersion forms of the compound. However, Birtalan et al. specifically provide motivation for increasing drug solubility and increasing bioavailability, specifically for BCL-2 binding compounds by using solid dispersions (see para. [0019], [0020]). A skilled artisan would have been motivated to use the compounds taught by the co-pending case in various forms, with a reasonable expectation of success, due to routine optimization.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(8 of 9) Claims 1, 3-7, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11993610. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1 and 3, the patent teaches the following compound in claim 1, drawn to the following structure:
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as a BCL-2 inhibitor, which is embraced by a compound of instant formulas (A-1):
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and (A-2):
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, wherein R9 = R9A =
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; L = bond and alkyl; Z1 = NH; Q7 = 6 membered aryl; W = O; Q1 and Q2 =
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; Q5 =
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; s = 1; R3 and R4 = H; Q4 =
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; R1 = Cl. . Regarding instant claims 4-6, dashed line is a single bond and W1 and W2 = N. Regarding instant claim 7, Z2 = O and f = 0. Regarding instant claim 16, the patent discloses the following:
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.
Regarding instant claims 1, 3-7 and 16, it would have been obvious to a skilled artisan to arrive at the instant claims from the species of the patent shown supra, with the analogous function of inhibiting BCL-2. The compound is a lead compound, as claimed, and is embraced by the instant claims genus. A PHOSITA would have been motivated to select identical species, embraced by both the patent and the instant claims/genus, with a reasonable expectation of success in inhibiting BCL-2.
(9 of 9) Claims 1, 3-7 and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/641,869 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The co-pending case teaches the following genus in claim 1, as BCL-2 inhibitors:
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. Regarding instant claims 1 and 3, the copending case teaches the following compound as the third compound down on p. 7 (claim 15), drawn to the following structure:
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, which is embraced by a compound of instant formulas (A-1):
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and (A-2):
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, wherein R9 = R9A =
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; L = bond and alkyl; Z1 = NH; Q7 = 6 membered aryl; W = O; Q1 and Q2 =
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; Q5 =
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; s = 1; R3 and R4 = H; Q4 =
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; R1 = Cl. . Regarding instant claims 4-6, dashed line is a single bond and W1 and W2 = N. Regarding instant claim 7, Z2 = O and f = 0. Regarding instant claim 16, claim 16 of the copending case recites the following:
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.
Regarding instant claims 1, 3-7 and 16, it would have been obvious to a skilled artisan to arrive at the instant claims from the species of the copending case shown supra, with the analogous function of inhibiting BCL-2. The compound is a lead compound, as claimed, and is a representation of both the copending case genus and the instant claims genus. A PHOSITA would have been motivated to select identical species, embraced by both the copending case and the instant claims/genus, with a reasonable expectation of success in inhibiting BCL-2.
Regarding instant claim 15, the compound of the copending case differs from the elected species of instant claim 15 by an extra alkyl group connected to the -CF3 on Q1, rendering the compounds homologs. “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its
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homologs because
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homologs
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often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” In re Deuel 34 USPQ2d 1210 at 1214. Furthermore MPEP 2144.09 (II) states: “Compounds which are […] homologs (…) 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).” The instant elected species and the prior art differ in the R10 location by an alkyl chain length (one carbon in the prior art and four carbons in the instant species). Such compounds are homologs and therefore a PHOSITA would have been motivated to explore various alkyl chain lengths with the expectation of arriving at compounds having similar utility and properties (BCL-2 inhibitors).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/MEGHAN C HEASLEY/Examiner, Art Unit 1626