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 1-12, 14-15, 18-21, 30-42, 45-50, 54, and 57-65 are pending. Claims 3-5, 7-12, 14-15, 18-21, 30-34, 38-39, 45-47, 50, 54, and 57-65 are withdrawn. Claims 1, 2, 6, 35-37, 40-42, and 48-49 are rejected.
Information Disclosure Statement
The Information Disclosure Statements (IDS’s) from 12/15/2023 (six) were considered by the Examiner.
Election/Restrictions
Applicant’s election without traverse of Group I and the species:
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262
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, which is embraced by a compound of instant Formula (I):
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233
223
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, wherein X = N; R1 = -Q-heterocyclyl, Q = bond:
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61
75
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, R2 = oxo and C1 alkyl (methyl); R12= H; R3 = C1 alkyl (methyl); R8 = C1 alkyl (methyl); R4 = aryl:
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74
83
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, R5 = halogen and haloalkyl, in the reply filed on 4/2/2026 is acknowledged.
Claims 1, 2, 6, 35-37, 40-42, and 48-49 embrace Applicant’s elected species and are therefore under examination. The elected species is allowable. As per MPEP 803.02, “Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability.” The examination of the Markush-type claims has been extended to include the non-elected species cited below under 35 USC 102 and 103 and double patenting, which are not allowable.
Claims 3-5, 7-12, 14-15, 18-21, 30-34, 38-39, 45-47, 50, 54, and 57-65 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 Objections
Claim 48 is objected to because of the following informalities: Line 1 on p. 18 should read: “A compound selected from the group consisting of” and the last line on p. 21 should read: “or a pharmaceutically acceptable salt thereof.”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 42 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 42 defines the “R4” variable and is not further limiting from claim 1, from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 49 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 42 depends from claim 1 and in line 3 includes “solvate thereof”, wherein claim 1 does not teach solvates. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 35, 40-42, and 49 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Toshiyuki et al. (WO2007066615).
Regarding instant claims 1, 35, and 40-42, Toshiyuki teaches the following compound in para. [0019]:
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101
182
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, which is embraced by a compound of instant Formula (I):
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233
223
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, wherein X = CH; R3= heterocyclyl:
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71
67
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; R1, R12 = H; R8 = C1 alkyl (methyl); R4 = aryl:
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74
74
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.
Regarding instant claim 49, Toshiyuki teaches the following in para. [0014]:
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102
728
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.
Claim(s) 1, 35, 40-42 and 49 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fiorelli et al. (US20240002371-earliest priority date of 11/27/2020).
Regarding instant claims 1, 35, and 40-42, Fiorelli discloses the following compound in Table 1, p. 7:
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169
412
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, which is embraced by a compound of instant Formula (I):
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, wherein X = CH; R1 = heteroaryl:
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70
96
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; R12 = H; R3 = cycloalkyl:
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49
50
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; R8 = C1 alkyl (methyl); R4 = heteroaryl, R5 = C1 alkyl:
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76
93
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.
Regarding instant claim 49, Fiorelli teaches the following in para. [0034]:
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.
Claim(s) 1, 6, 35-37, 40-42, and 49, is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Li et al. (WO2022017339-earliest priority date of 7/20/2020).
Regarding instant claims 1, 6, 35-37, and 40-42, Li et al. discloses the following compound in claim 17:
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, which is embraced by a compound of instant Formula (I):
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, wherein X = C, R7 = alkoxy (-O-CH3); R1 = Q-heterocyclyl:
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112
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, R2 = -C(O)C1 alkyl, Q = bond; R12 = H; R3, R8 = C1 alkyl (methyl); R4 = aryl:
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95
109
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, R5 = halogen and haloalkyl.
Regarding instant claim 49, see Eng. Translation p. 36 of Li (second para. from bottom):
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731
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.
Claim(s) 1, 2, 6, 35-37, 40-42 and 49 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Haling et al. (US20220395507- earliest priority date is 5/27/2021).
Regarding instant claims 1, 2, 6, 35-37, and 40-42, Haling discloses the following compound in claim 20:
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, which is embraced by a compound of instant Formula (I):
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, wherein X = N; R12 = H; R1 = -Q-heterocyclyl:
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86
86
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, Q = bond; R3, R8 = C1 alkyl (methyl); R4 = aryl:
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, R5 = cyano and methyl.
Regarding instant claim 49, Haling discloses the following in para. [0101]:
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298
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.
Claim(s) 1, 2, 6, 35-37, 40-42 and 49 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Haling et al. (US12280055- earliest priority date is 5/27/2021).
Regarding instant claims 1, 2, 6, 35-37, and 40-42, Haling discloses the following compound in claim 14:
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, which is embraced by a compound of instant Formula (I):
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233
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, wherein X = N; R12 = H; R1 = -Q-heterocyclyl:
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86
86
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, Q = bond; R3, R8 = C1 alkyl (methyl); R4 = aryl:
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, R5 = cyano and methyl.
Regarding instant claim 49, Haling discloses the following in column 90, lines 5-10:
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306
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.
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) 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haling et al. (US20220395507- earliest priority date is 5/27/2021).
**The 102 rejection supra over Haling et al. (US20220395507- earliest priority date is 5/27/2021) of claims 1, 2, 6, 35-37, 40-42 and 49, is incorporated herein by reference.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The compound taught by Haling is designated to treat KRAS G12C cancers (see abstract).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art compound shown above has a hydrogen in place of a methyl of instant compound on bottom left of p. 20, instant claim 48 (arrow added by Examiner):
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.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claim 48, the compounds of the instant claims (see instant claim 60) are also useful in treating KRAS G12C cancers. The prior art compound differs from a compound of the instant claims in a hydrogen vs. methyl difference, rendering the compounds analogs. The compounds as taught by the prior art and the compounds 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 prior art 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.
Claim(s) 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haling et al. (US12280055- earliest priority date is 5/27/2021).
**The 102 rejection supra over Haling et al. (US12280055- earliest priority date is 5/27/2021) of claims 1, 2, 6, 35-37, 40-42 and 49, is incorporated herein by reference.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The compound taught by Haling is designated to treat KRAS G12C cancers (see abstract).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art compound shown above has a hydrogen in place of a methyl of instant compound on bottom left of p. 20, instant claim 48 (arrow added by Examiner):
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.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claim 48, the compounds of the instant claims (see instant claim 60) are also useful in treating KRAS G12C cancers. The prior art compound differs from a compound of the instant claims in a hydrogen vs. methyl difference, rendering the compounds analogs. The compounds as taught by the prior art and the compounds 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 prior art 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.
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) Claim 1, 2, 6, 35-37, 40-42, and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 12280055. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1, 2, 6, 35-37, and 40-42, U.S. Patent No. 12280055 discloses the following compound in claim 14, as useful in a method for inhibiting KRAS G12C activity in a cell and used in combination with adagrasib:
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, which is embraced by a compound of instant Formula (I):
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, wherein X = N; R12 = H; R1 = -Q-heterocyclyl:
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86
86
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, Q = bond; R3, R8 = C1 alkyl (methyl); R4 = aryl:
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119
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, R5 = cyano and methyl. While the claims of US12280055 are drawn to use of the compound shown supra in combination with another drug, the instant disclosure allows for combinations (see para. [0173]). Additionally, the instant disclosure recites the following in para. [0007]: “Thus, the compounds of the present invention that block the interaction between SOS1 and Ras-family members prevent the recycling of KRas into the active GTP-bound form and, therefore, may provide therapeutic benefit for a wide range of cancers, particularly Ras family member-associated cancers”.
Regarding instant claim 48, the compounds of the instant claims (see instant claim 60) are also useful in treating KRAS G12C cancers. The prior art compound differs from a compound of the instant claims in a hydrogen vs. methyl difference, rendering the compounds analogs. The compounds as taught by the prior art and the compounds 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 prior art 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.
(2 of 3) Claim 1, 2, 6, 35-37, 40-42, and 48-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-81 of U.S. Patent No. 12304915. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1, 2, 6, 35-37, and 40-42, U.S. Patent No. 12304915 discloses the following compound in claim 68, as useful in a method for treating cancer in a cell:
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, which is embraced by a compound of instant Formula (I):
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, wherein X = N; R12 = H; R1 = -Q-heterocyclyl:
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86
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, Q = bond; R3, R8 = C1 alkyl (methyl); R4 = aryl:
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, R5 = cyano and methyl. Regarding instant claim 49, the end of claim 68 from US12304915 recites the following:
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. The instant disclosure recites the following in para. [0007]: “Thus, the compounds of the present invention that block the interaction between SOS1 and Ras-family members prevent the recycling of KRas into the active GTP-bound form and, therefore, may provide therapeutic benefit for a wide range of cancers, particularly Ras family member-associated cancers”.
Regarding instant claim 48, the compounds of the instant claims (see instant claim 60) are also useful in treating cancers. The prior art compound differs from a compound of the instant claims in a hydrogen vs. methyl difference, rendering the compounds analogs. The compounds as taught by the prior art and the compounds 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 prior art 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.
(3 of 3) Claim 1, 2, 6, 35-37, 40-42, and 48-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-72 of U.S. Patent No. 11702418. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1, 2, 6, 35-37, and 40-42, U.S. Patent No. 11702418 discloses the following compound in claim 70, as a SOS1 inhibitor (see abstract):
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, which is embraced by a compound of instant Formula (I):
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, wherein X = N; R12 = H; R1 = -Q-heterocyclyl:
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86
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, Q = bond; R3, R8 = C1 alkyl (methyl); R4 = aryl:
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, R5 = cyano and methyl. Regarding instant claim 49, claim 69 from the patent recites the following:
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.
Regarding instant claim 48, the compounds of the instant claims are also SOS1 inhibitors (See title). The prior art compound differs from a compound of the instant claims in a hydrogen vs. methyl difference, rendering the compounds analogs. The compounds as taught by the prior art and the compounds 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 prior art 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.
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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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
