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 1 and 90-108 are pending as of the response filed 04/24/2026. Claims 2-89 are cancelled. Applicant’s election of group I claims 1 and 90-107 without traverse, is acknowledged. Claim 108 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election of a species of compound as Compound 229 without traverse, is acknowledged.
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Claims 1, 90-91 and 98-107 encompass the elected species. Claims 92-97 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 1, 90-91 and 98-107 have been examined to the extent to which they are readable on the above identified elected species.
The elected species was examined and found to be free of prior art. The examiner has expanded the search of the Markush claim to the following species that anticipates instant Formula I.
In view of the pending claims, the following rejections are made, as discussed below.
Priority
This application is a 371 of PCT/CN2022/112674 filed 08/16/2022 and claims foreign priority to PCTCN2021112906 filed 08/17/2021.
The subject matter of claims 1, 90-91 and 98-107 are supported by the ‘906 foreign priority application and accordingly, have an effective filing date of 08/17/2021.
Information Disclosure Statement
The information disclosure statement submitted on 01/11/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112 – Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 90-91 and 98-105 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is drawn to a compound having the structure of Formula I, or a pharmaceutically acceptable salt thereof, with variables as defined in claim 1.
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The genus of compounds of Formula I as claimed, encompass a highly divergent variety of core structures as defined by the variables R1, R2, Z, L1, L2, L3, X, ring A and ring B, with various sub-genus. Each of the variables R1 and R2 can be selected to be a hydrogen, halogen, CN, OR10, SR11, S(O)R12 S(O)₂R13, optionally substituted alkyl, optionally substituted alkenyl, optionally substituted alkynyl, optionally substituted carbocyclyl, optionally substituted heteroaryl, or optionally substituted heterocyclyl; L1 and L2 can independently be null, O, S, S(O), S(O)2, NR16, C(O), C(O)O, C(O)NR16, OC(O)NR16 S(O)2NR16, NR17C(O)NR16 NR 17S(O)₂NR16, optionally substituted alkylene, optionally substituted alkenylene, optionally substituted alkynylene, optionally substituted heteroalkylene, optionally substituted carbocyclylene, optionally substituted heterocyclylene, optionally substituted phenylene, or optionally substituted heteroarylene; ring A is an optionally substituted carbocyclic or heterocyclic ring; ring B is an optionally substituted aryl or heteroaryl ring, etc.. The variables R10, R11, R12, R13, R16 and R17 can further be selected from a divergent set of functional groups. The compounds include pharmaceutically acceptable salts thereof. The instant specification teaches these pyridazinone and pyridinone compounds as poly(ADP-ribose)polymerases (PARP) inhibitors (Para. [0004] of instant specification).
Therefore, the scope of the claims is extremely broad and the genus/sub-genus of compounds of Formula I encompassed by the claims, includes species that do not share both a substantial structural feature and a common function that flows from the substantial feature. The different groups would be presumed by one of ordinary skill in the art to have different physical properties (e.g. solubility, stability, etc.) that would lead to different biological activities (e.g. ADME and PK/PD, efficacy, toxicity, etc.). Moreover, the specification does not provide a reasonably representative disclosure of the compounds of Formula I overall. Specifically, the specification discloses the synthesis of a limited number of species listed in Table A, wherein an overwhelming majority of the compounds have piperazinyl for ring A and pyrimidinyl for ring B (Para. [0135]; instant claim 106; Paras. [0224]-[0447]). All pharmacological data with respect to PARP7 inhibitory assays, pertain to these very same compounds (Para. [0448], Table 2). The specification discloses the inhibitory activity of a subset of these compounds on Non-Small Cell Lung Cancer cell lines (Paras. [0449]-[0450]). These are not viewed as being reasonably representative of the genus in its claimed scope because no readily apparent combination of identifying characteristics is provided, other than the disclosure of those specific species as examples of the claimed genus. It is not readily apparent that the genus of compounds claimed have a structural entity in common, that leads to their PARP7 inhibitory activity.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. Whether the specification shows that the inventor was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See MPEP 2163 (II) 3 (a) (i).
A chemical genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has substantial variance, the disclosure must describe a sufficient number of species to reflect the variation within that genus. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615. "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed. See MPEP 2163 (II) 3 (a) (ii).
In the instant case, there is no evidence Applicants had possession of the full genus of compounds at the time of filing, because the specification does not conclusively demonstrate the structure-activity relationship of the claimed vast array of compounds, towards their PARP7 inhibitory activity. The instant specification does not describe enough species of compounds having the PARP7 modulating function within the scope of the claimed invention. Thus, the written description requirement for the claimed genus of compounds has not been met.
In response to this rejection, the Applicant can amend the claim(s) to recite only individual species or grouping of species that share a substantial structure as well as a common function that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claim(s) in fact share a common function that flows from the substantial structural feature.
Claims 90-91 and 98-105 are similarly rejected for depending from a rejected base claim and are drawn to a broad genus of compounds.
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, 90-91 and 98-107 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 1, the claim recites “Z is N or C, preferably N”, “preferably, L1 and L2 are not both null”. The recitation of the limitation “preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Thus, the metes and bounds of the claims are unclear.
For the purpose of applying prior art, claim 1 has been interpreted to
exclude the language that follows the limitation “preferably”.
Regarding claim 90, the claim recites “R1 is C1-4 alkyl … each of which is optionally substituted with one or more (e.g., 1-3) substituents independently selected from F …”. The claim also recites “R1 is methyl, ethyl, isopropyl, … CF3”. The claim includes multiple instances of exemplary claim language, “(e.g., 1-3)”. The recitation of the limitation in parentheses and “e.g.,” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP 2173.05 (c). In the present instance, claim 90 recites the broad recitation C1-4 alkyl optionally substituted with one or more substituents for the variable R1, and the claim also recites a narrower recitation of methyl, ethyl, isopropyl, … CF3 for the variable R1, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Therefore, the metes and bounds of claim 90 are indefinite.
For the purpose of applying prior art, claim 90 has been given the broadest reasonable interpretation for the functional groups defining the variable R1 and without the limitations appearing in parentheses.
Regarding claim 91, the claim recites “R2 is C1-4 alkyl C2-4 alkenyl, C2-4 alkynyl, or C3-6 cycloalkyl, each of which is optionally substituted with one or more (e.g., 1-5 or 1-3) substituents independently selected from (1) halo (preferably, F) …”. The claim also recites “R2 is methyl, CF3, …”. The claim includes multiple instances of exemplary claim language, (e.g., 1-5 or 1-3)”, “(preferably, F)”, etc.. The claim includes the recitation of the limitation “such as
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” The recitation of the limitation in parentheses, “e.g.,”, “preferably” and “such as” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP 2173.05 (c). In the present instance, claim 91 recites the broad recitation C1-4 alkyl optionally substituted with one or more substituents for the variable R2, and the claim also recites a narrower recitation of methyl, CF3 for the variable R2, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Therefore, the metes and bounds of claim 91 are indefinite.
For the purpose of applying prior art, claim 91 has been given the broadest reasonable interpretation for the functional groups defining the variable R2, without the limitations appearing in parentheses and without the limitations following “such as”.
Regarding claim 99, the claim recites “wherein L2 is null, O, optionally substituted C1-4 alkylene … preferably, L2 is null CH2, CH2CH2, …”.
The recitation of the limitation in “preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Moreover, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP 2173.05 (c). In the present instance, claim 99 recites the broad recitation of C1-4 alkylene for the variable L2, and the claim also recites a narrower recitation of CH2, CH2CH2 for the variable L2, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Therefore, the metes and bounds of claim 99 are indefinite.
For the purpose of applying prior art, claim 99 has been given the broadest reasonable interpretation for the functional groups defining the variable L2 and without the limitations following “preferably”.
Regarding claim 100, the claim recites “R6 at each occurrence is independently F, Cl, Br, CN, C1-4 alkyl optionally substituted with 1-5 (e.g., 1, 2, or 3) GC …”. The recitation of the limitation in parentheses and “e.g.,” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
For the purpose of applying prior art, claim 100 has been interpreted without the limitations appearing in parentheses.
Regarding claim 102, the claim recites “A is … substituted with 1-5 (e.g., 1, 2, or 3) GA, wherein GA at each occurrence is independently halo (preferably, F) … two substituents of the piperazine or pyrrolidine, together with the intervening atom(s), are joined to form a 3-4 membered ring, such as cyclopropyl, … e.g., ring A can be …”. The claim has multiple instances of parentheses, “e.g.,”, “preferably” and “such as” recited in the claims. The recitation of the limitation in parentheses, “preferably”, “e.g.,” and “such as” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
For the purpose of applying prior art, claim 102 has been interpreted without the limitations appearing in parentheses and without the limitations following “preferably” and “e.g.,”.
Regarding claim 106, the claim reads “A compound selected from Compound Nos. 1-353, or compounds in Table A below”. However, the compounds are not labeled as compound nos. 1-353, and rely on the specification for the identity of the compounds. Claims should be complete and cannot rely on the specification to describe what is being claimed. See MPEP 2173.05(s), which states, “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).” The reference to the specification renders the metes and bounds of the claim indefinite.
For the purpose of applying prior art, claim 106 has been interpreted as “A compound selected from compounds in Table A below, or a pharmaceutically acceptable salt thereof:” without the reference to Compound Nos. 1-353.
Claims 98, 101, 103-105 and 107 are similarly rejected as depending from a rejected base claim and do not remedy the indefiniteness.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 99 and 101-104 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Javaid et al. (US 2006/0063767 A1, 23 March 2006, hereinafter Javaid, in the IDS).
Regarding instant claim 1, Javaid teaches phthalazinone compounds of formula (I) with variables as defined, for use in treating cancer (Abstract) having PARP inhibitory activity (Para. [0195]).
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Javaid teaches an exemplary compound, compound 50 (Para. [0312]). Compound 50 has the following structure -
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, R being
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.
Compound 50 of Javaid falls within the scope of Formula I of instant claim 1, wherein
R1 and R2 together with the intervening atoms are joined to form a cyclic structure (phenyl);
Z is N;
L1 is optionally substituted alkylene (methylene);
L2 is optionally substituted heteroarylene (thiophenyl);
X is C(O);
A is an optionally substituted heterocyclic ring (piperazinyl);
L3 is null;
Ring B is an optionally substituted heteroaryl ring (pyridinyl).
Compound 50 of Javaid further reads on the limitations of instant claims 99 and 101-104.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 98-103 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ji et al. (US 2015/0368205 A1, 24 December 2015, hereinafter Ji, in the IDS).
Regarding instant claim 1, Ji teaches phthalic hydrazide (phthalazine ketone) compounds, and a pharmaceutical composition comprising the same as a DNA repair enzyme poly (ADP-ribozyme) polvmerase inhibitor (Abstract). Ji teaches compounds of Formula (I) with variables as defined (Paras. [0025]-[0038]).
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Ji teaches the exemplary compound, compound 110 (Para. [0073], Pg. 36).
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Compound 110 of Ji falls within the scope of Formula I of instant claim 1, wherein
R1 and R2 together with the intervening atoms are joined to form a cyclic structure (phenyl);
Z is N;
L1 is O;
L2 is optionally substituted phenylene (fluorophenyl);
X is C(O);
A is an optionally substituted heterocyclic ring (piperazinyl);
L3 is null;
Ring B is an optionally substituted aryl (fluorophenyl).
Compound 110 of Ji further reads on the limitations of instant claims 98-99, 100 (Formula I-D-1), 101-103.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 99 and 101-104 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gandhi et al. (US 2014/0212509 A1, 31 July 2014, hereinafter Gandhi).
Regarding instant claim 1, Gandhi teaches Inhibitors of poly(ADP-ribose)polymerase (Abstract; Para. [0002]). Gandhi teaches PARP inhibitors of formula I, with variables as defined (Paras. [0006]-[0040]).
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Gandhi teaches the following exemplary compound (Pg. 31, Table 3).
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The compound of Gandhi falls within the scope of Formula I of instant claim 1, wherein
R1 and R2 together with the intervening atoms are joined to form a cyclic structure (cyclohexyl);
Z is N;
L1 is alkylene (methylene);
L2 is optionally substituted phenylene (fluorophenyl);
X is C(O);
A is a heterocyclic ring (piperazinyl);
L3 is null;
Ring B is heteroaryl (pyrimidinyl).
The compound of Gandhi further reads on the limitations of instant claims 99 and 101-104.
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)(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.
Claims 1, 90-91, 99, 101-107 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Li et al. (WO 2022/253101 A1, which claims priority to CN 202110605018.4 with a effectively filed date of 31 May 2021, hereinafter Li) (citations are made to the attached English translation of Li).
Li qualifies as prior art under 35 U.S.C. 102(a)(2) since it is a disclosure by another with no common Applicant or inventive entity and has an effectively filed date of 31 May 2021, that precedes the effective filing date of the instant claims, 17 August 2021. Moreover, the subject matter relied upon in this rejection is described in the CN 202110605018.4 foreign priority application of Li (Pg. 29, synthesis of compound 6; Pg. 7, third row, second compound – priority document can be obtained from WIPO Patentscope).
Regarding instant claim 1, Li teaches pyridazinone compounds or a pharmaceutically acceptable salt thereof as PARP7 inhibitors (Abstract; Pg. 13, first full paragraph). Li teaches a pharmaceutical composition comprising the pyridazinone compound or a pharmaceutically acceptable salt thereof (Pg. 13, seventh full paragraph) with a pharmaceutically acceptable excipient (Pg. 40, eleventh to thirteenth full paragraphs). Li teaches compounds of formula I, with variables as defined (Pg. 13 last paragraph - Pg. 15, continued paragraph).
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Li teaches the exemplary compound, compound 6 (Pg. 48, synthesis scheme).
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Compound 6 of Li falls within the scope of Formula I of instant claim 1, wherein
R1 is substituted alkyl (CF3);
R2 is hydrogen;
Z is N;
L1 is optionally substituted heterocyclylene (pyrrolidinyl);
L2 is optionally substituted alkylene (ethylene);
X is C(O);
A is an optionally substituted heterocyclic ring (piperazinyl);
L3 is null;
Ring B is an optionally substituted heteroaryl ring (pyrimidinyl substituted with CF3).
Compound 6 of Li further reads on the limitations of instant claims 90-91, 99, 101-106. Specifically Li anticipates the following compound of instant claim 106 (Pg. 21, second compound in row 2 of claim set dated 09/10/2024).
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Compound 6 of Li Compound of instant claim 106
Therefore, Li anticipates the compounds of instant claims 1, 90-91, 99, 101-106 and the pharmaceutical composition of instant claim 107.
Conclusion
Claims 1, 90-91 and 98-107 are rejected.
No claims 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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/PADMAJA S RAO/Examiner, Art Unit 1627
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