DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims and Response to Restriction Requirement
Claims 93-94, 98, 103-110, 116-129 are pending as of the response filed 07/01/2026. Claims 1-92, 95-97, 99-102, 111-115 are cancelled. Claims 116-129 are newly added. Applicant’s election of group I claims 93-94, 98, 103-110, 116-129 (that includes the newly added claims) without traverse, is acknowledged. The examiner notes that the group II claims 111-115 drawn to the nonelected invention have been cancelled.
Applicant’s election of a species of compound as compound 413 of example 314 without traverse, is acknowledged.
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Applicant indicates claims 93, 94, 98, 103-110 and 116-126 encompass the elected species. The examiner respectfully disagrees and notes that claims 93-94, 98, 103-107, 109-110, 116-119, 121-122, 124-126 encompass the elected species. Claims 108, 120, 123 and 127-129 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim (claim 108 does not allow for EII and L2-II to both be either a bond or absent simultaneously). Claims 93-94, 98, 103-107, 109-110, 116-119, 121-122 and 124-126 have been examined to the extent to which they are readable on the above identified elected species.
The elected species was found to be free of prior art. Therefore, the examiner has extended the search to the full scope of the compounds of Formula (I-c). In view of the pending claims, the following objections and rejections are made.
Priority
This application is a 371 of PCT/US2021/057300 filed 10/29/2021 and claims priority to PRO 63/256,991 filed 10/18/2021 and PRO 63/108,109 filed 10/30/2020.
Applicant’s claim for the benefit of a prior filed application under 35 U.S.C. 119(e) or under or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or earlier-filed nonprovisional application or provisional application for which benefit is claimed). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/108,109 filed 10/30/2020 fails to provide adequate support and enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The ‘109 application does not disclose RA is halo-C1-C6 alkoxy-C1-C6 alkylene (required to support the instantly elected species of compound). Accordingly, the instant claims 93-94, 98, 103-107, 109-110, 116-119, 121-122 and 124-126, have an effective filing date of 10/18/2021, the subject matter of which is supported in PRO 63/256,991 filed 10/18/2021.
Information Disclosure Statement
The information disclosure statements submitted on 10/01/2024 and 07/01/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 94 is objected to because of the following informalities:
In claim 94, there are two occurrences of “and” appearing within the definition of the variable “D”. It is suggested that the first occurrence of “and” be removed from the claim.
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.
Claims 93-94, 98, 103-107, 116-119, 121-122 and 124 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.
Regarding claim 93, the claim recites “R2 is hydrogen or C1-C6 alkyl” (Pg. 3 of claim set dated 07/01/2026); “each RZ is independently selected from the group …” (Pg. 6 of claim set dated 07/01/2026); and “each RG is independently hydrogen, …”(Pg. 7 of claim set dated 07/01/2026). However, claim 93 does not define any of the variables or functional groups that include R2, RZ and RG within its scope, introducing ambiguity regarding the scope of the claim. Therefore, the metes and bounds of the claim are indefinite.
For the purpose of applying prior art, claim 93 has been interpreted without the definition of the limitations R2, RZ and RG appearing in the claim.
Claims 94, 98, 103-107, 116-119, 121-122 and 124 depend from claim 93 either directly or indirectly and are similarly rejected since they do not remedy the indefiniteness.
Regarding claim 106, the claim recites “each of D, R1, RW2, RX, and RA is defined as for Formula (I-c)” and further recites the following within the claim.
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It is not clear if these have been struck off from the claim or are definitions of the variable D. Therefore, the metes and bounds of the claim are indefinite.
For the purpose of applying prior art, claim 106 has been interpreted without the above structures appearing in the claim.
Regarding claim 124, the claim recites “wherein W is substituted with 2 RW2”. However, the compound of Formula (I-c) in claim 93 does not have a “W” variable as amended, introducing ambiguity regarding the scope of the claim. Therefore, the metes and bounds of the claim are indefinite.
For the purpose of applying prior art, claim 124 has been interpreted to read “wherein the compound of Formula (I-c) is substituted with 2 RW2”.
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.
Claims 94, 104, 119 are 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.
Regarding claim 94, the claim depends from claim 93 and recites “D is selected from the group consisting of” that includes the groups shown below.
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However, the above groups do not show the attachment points for the above groups within the compound of Formula (I-c), while the D groups of claim 93 does. This broadens the scope of claim 93, which is improper.
Regarding claim 104, the claim depends from claim 93 and recites “wherein each RY is independently selected from the group consisting of … phenyl, …. and cyclopropyl”. However, the options of “phenyl” and “cyclopropyl” is not supported by the definition of RY in claim 93. This broadens the scope of claim 93, which is improper.
Regarding claim 119, the claim depends from claim 93 and recites “wherein each RY is independently selected from the group consisting of … and cyclopropyl”. However, the option of “cyclopropyl” is not supported by the definition of RY in claim 93. This broadens the scope of claim 93, which is improper.
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 § 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 109 is rejected under 35 U.S.C. 103 as being unpatentable over Martin et al. (US 2020/0347043 A1, 05 November 2020, hereinafter Martin, in the IDS). (Martin with partial joint inventors and partial common ownership qualifies as prior art under 35 U.S.C. 102(a)(1)/35 U.S.C. 102(a)(2) with a publication date of 05 November 2020 and a filing date of 30 April 2020, that is before the effective filing date of 18 October 2021)
Regarding instant claim 109, Martin teaches compounds useful for modulating the integrated stress response (ISR) and for treating related diseases, disorders and conditions (Abstract). Martin teaches compounds of Formula (I), or a pharmaceutically acceptable salt, solvate, hydrate, tautomer, N-oxide, or stereoisomer thereof, with variables as defined (Paras. [0006]-[0041]).
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Martin teaches the following exemplary compounds, compounds 346 and 347 (TABLE 2, Pg.81).
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The above compounds of Martin have the same structure as that of the following compound of instant claim 109 (Pg. 22 of the claim set dated 07/01/2026) but differs in the configuration of the various stereocenters.
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According to MPEP 2144.09 (III), “Prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979). See also In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (claimed and prior art compounds used in a method of treating depression would have been expected to have similar activity because the structural difference between the compounds involved a known bioisosteric replacement)”.
Further according to MPEP 2144.09 (I), “A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).”
In the instant case, Martin teaches compounds of Formula (I), or a stereoisomer thereof as modulators of the integrated stress response (ISR). The instant compounds are taught to be modulators of the integrated stress response (ISR) (Title, Pg. 2, Lns. 15-24 of the instant specification). Therefore, one of ordinary skill in the art would have been motivated to synthesize various stereoisomers of the cited compound to arrive at the compound of the instant claims, with a reasonable expectation of success. Doing so would have been well within the skill of one of ordinary skill in the pharmaceutical arts, through routine experimentation.
In the absence of any unexpected results or criticality of the specific stereoisomer, the instantly claimed compound of claim 109 is prima facie obvious.
Miscellaneous
The examiner would like to bring Applicant’s attention to the following:
A power of attorney document is not present in the application file.
Allowable Subject Matter
The compounds of Formula (I-c) as in instant claim 93 and the compound of claim 110 are free of prior art.
The following is a statement of reasons for the indication of allowable subject matter:
The instant claims are drawn to a compound of Formula (I-c) as in instant claim 93 or a pharmaceutically acceptable salt thereof and a compound of claim 110 or a pharmaceutically acceptable salt thereof.
The closest prior art of record is Martin et al. (US 2020/0347043 A1, 05 November 2020, hereinafter Martin, in IDS). Martin teaches compounds useful for modulating the integrated stress response (ISR) and for treating related diseases, disorders and conditions (Abstract). Martin teaches compounds of Formula (I), or a pharmaceutically acceptable salt, solvate, hydrate, tautomer, N-oxide, or stereoisomer thereof, with variables as defined (Paras. [0006]-[0041]).
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Martin teaches the following exemplary compound, compound 346 (TABLE 2, Pg.81).
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Compound 346 of Martin overlaps the scope of the compound of Formula (I-c) wherein
RW2 is 1, being halo (Cl);
R1 is H;
D is
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, Rx is 0;
E is absent;
L2 is a bond;
A is a 5-membered heteroaryl (pyrazole) substituted with 1 Ry,
However, Ry being
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does not fall within the scope of the definition of Ry of instant claim 93 (the closest RY is halo-C1-C6 alkoxy-C1-C6 alkylene that accounts for the CF3-O-CH2-, but the cyclopropyl group is unaccounted for in the definition of RY). The prior art of record does not teach or suggest the compounds of the instant invention of Formula (I-c).
Conclusion
Claims 93-94, 98, 103-107, 109, 116-119, 121-122 and 124 are rejected.
Claim 94 is objected to.
Claims 110, 125-126 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached 9:00-5:30pm EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PADMAJA S RAO/Examiner, Art Unit 1627
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