DETAILED ACTION
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 1-3, 6, 10, 11, 13, 15-19, 23, and 24 are pending. Claims 4, 5, 7-9, 12, 14, and 20-22 are cancelled.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/CN2023/093538, filed on May 11, 2023. This application also claims the benefits of foreign priority to:
CN202210520744.0, filed on May 13, 2022,
CN202210878192.0, filed on July 25, 2022,
CN202211183092.2, filed on September 27, 2022,
CN202211537992.2, filed on December 2, 2022,
CN202310071265.X, filed on January 16, 2023,
CN202310288871.7, filed on March 22, 2023, and
CN202310475180.8, filed on April 27, 2023.
Specification - Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class.
Specification - Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1-3, 6, 10, 11, 13, 15-19, 23, and 24 are objected to because of the following informalities:
To avoid 112a issues and to ensure proper format, in claims 1-3, 6, 10, 11, 13, 15-19, and 23:
“…or pharmaceutically acceptable salts, stereoisomers, isotope isomers, prodrugs, hydrates, or solvates of the compound…” in claim 1 should be written in singular form as follows:“…or a pharmaceutically acceptable salt[[s]], stereoisomer[[s]], isotope isomer[[s]], hydrate[[s]], or solvate[[s]] of the compound…”
“…or the pharmaceutically acceptable salts, the stereoisomers, the isotope isomers, the prodrugs, the hydrates, or the solvates of the compound…” in claims 2, 3, 6, 10, 11, 13, 15-19, and 23 should be written in singular form as follows:“…or the pharmaceutically acceptable salt[[s]], the stereoisomer[[s]], the isotope isomer[[s]], the hydrate[[s]], or the solvate[[s]] of the compound…”
To be consistent with claim 10, in claim 1 on pg. 272:
“OR Ra and Rb, together with an atom attaching to the OR Ra and the Rb, form a 3-6-membered saturated or unsaturated ring…” should read:“or Ra and Rb, together with an atom attaching to the [[OR]] Ra and the Rb, form a 3-6-membered saturated or unsaturated ring…”
Claim 1 also recites the following on pg. 271:
“…the Cy2 is optionally substituted with 0-3 substituents selected from the following: halogen, C1-C6 haloalkyl, C1-C6 haloalkyl, hydroxy(C1-C6 alkyl)…”
Note: “C1-C6 haloalkyl” appears twice.
To avoid repetition and to ensure the claims are written concisely, claim 1 should read:“…the Cy2 is optionally substituted with 0-3 substituents selected from the following: halogen, C1-C6 haloalkyl, hydroxy(C1-C6 alkyl)…”
Claim 13 recites a list of Cy1 groups, wherein the list contains many Cy1 duplicates. Some of the many other duplicates are shown below:
Entry no.
Cy1 structure
Where in claim 13 this Cy1 structure can be found
1
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Pg. 274, row 4, col. 4 and
Pg. 276, row 4, col. 3
2
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99
109
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Pg. 274, row 1, col., 3 and
Pg. 278, row 1, col. 1
3
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95
114
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Pg. 274, row 2, col. 1 and
Pg. 278, row 1, col. 2
4
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97
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Pg. 274, row 2, col. 4 and pg. 278, row 1, col. 3
5
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99
112
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Pg. 276, row 1, col. 2 and
Pg. 278, row 1, col. 4
6
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100
115
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Pg. 276, row 2, col. 2 and
Pg. 278, row 2, col. 1
7
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100
113
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Pg. 276, row 3, col. 2,
Pg. 278, row 3, col. 2, and
Pg. 280, row 3, col. 2
8
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Pg. 276, row 3, col. 4,
Pg. 278, row 3, col. 3,
Pg. 278, row 3, col. 4,
Pg. 280, row 3, col. 3
9
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99
109
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Pg. 277, row 3, col. 2,
Pg. 279, row 3, col. 2, and
Pg. 281, row 3, col. 2
10
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Pg. 277, row 3, col. 4,
Pg. 279, row 3, col. 3,
Pg. 279, row 3, col. 4, and
Pg. 281, row 3, col. 3
Also in claim 13, not all Cy1 groups recited show two points of attachment:
For example, on pg. 275, row 5, col. 1, the Cy1 group,
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, only shows one point of attachment. This group should be re-drawn as:
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.
Please ensure that all Cy1 groups recited in instant claim 13 are drawn in a way that indicates there are two points of attachment.
Also in claim 13, please ensure that all atoms have proper valency:
E.g.,
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(pg. 284, row 1, col. 1) should be re-drawn as
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to ensure that the N atom has proper valency.
In claim 23, the Cy2 group,
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, appears twice (on pg. 287 and on pg. 288, 1st row, 1st col.).
To avoid repetition and ensure conciseness of the claims, please delete one of the
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groups.
Claim 24 is objected to because of the following informalities:
Rule 1.141(a) states:
Two or more independent and distinct inventions may not be claimed in one national application, except that more than one species of an invention, not to exceed a reasonable number, may be specifically claimed in different claims in one national application, provided the application also includes an allowable claim generic to all the claimed species and all the claims to species in excess of one are written in dependent form (§ 1.75) or otherwise include all the limitations of the generic claim.
Claim 24 claims a large number of species of the generic claim, but in independent format. Multiple inventions may not be claimed in a single application unless they are species claims which are dependent upon the larger, generic claim. In the past, the Office has held a “reasonable number” to be five (5) species. The present claim contains well over this number of species. One could envision forty pages of species compounds in a single claim which is not dependent upon any genus claim. This would cause undue burden to the Office in examining such a large claim. Therefore, it is recommended that Claim 24 either be dependent from a larger, genus claim, or that claim 24 incorporates all of the limitations of the genus claim. Applicants are invited to contact the examiner if further clarification is needed. No new matter is permitted.
Note: There are some compounds recited in instant claim 24 that are not encompassed by instant claim 1 (e.g., instant compound 16 has Cy2 = -NH-C(CH3)2-CH2-OH which is not a cyclic structure; according to instant claim 1, Cy2 has to be a ring structure). Therefore, if claim 24 is amended to be dependent from a larger, genus claim (i.e., instant claim 1), or if claim 24 incorporates all of the limitations of the genus claim (i.e., instant claim 1), please ensure that all the compounds recited in instant claim 24 properly depends from instant claim 1.
Appropriate correction is required.
Claim Rejections – Improper Markush Grouping
Claims 1-3, 6, 10, 11, 13, 15-19, 23 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if: (1) the species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the Specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons:
The claimed Markush group encompasses compounds having substantially different core structures. Some example core structures are depicted below:
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,
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, and
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.
Clearly no ‘‘single structural similarity’’ can be seen amongst the different core structures described above which are ring structures linked together wherein, the rings possess different molecular geometries as well as electronic (and, therefore, chemical) properties.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. § 134 and 37 CFR41.31 (a) (1) (emphasis provided)
Claim Rejections - 35 USC § 112(a)
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.
Written Description
Claims 1-3, 6, 10, 11, 13, 15-19, and 23 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(s) 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.
Currently, the claims are broad insofar as the instant claims recite a compound of instant formula I wherein the compound can possess a structurally diverse range of chemical substituents and substantially different core scaffolds.
Although the instant claims are broad, the instant specification provides limited working examples.
According to MPEP § 2163:
“Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’ Such correlations may be established ‘by the inventor as described in the specification,’ or they may be ‘known in the art at the time of the filing date.’ See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014).
The instant specification provides specific examples of compounds encompassed by instant claim 1 (see pg. 22-29 for structures). The working examples do not adequately represent the full breadth of the claimed genus which was established to be broad. For example, according to instant claim 1, the compound of Formula I can possess many different core structures, wherein each of these core structures can be substituted with structurally diverse substituents. However, in the instant case, the specific examples consistently possess the following structural features:
R1 =
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or L3 – R3
wherein L3 – R3 = -NRa-SO2-(C1-6 alkyl)
wherein Ra = H and C1-6 alkyl is optionally substituted with 0-3 OH
W1 = CRW1 or N
Wherein RW1 = H
W2 = CRW2 or N
Wherein RW2 = H
R2 = H
Z =
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L1 = 5-membered heteroaryl
Cy1 = phenyl or 6-10 membered heteroaryl
Wherein the Cy1 is optionally substituted with 0-3 substituents selected from the following:
halogen, C1-C6 alkyl, hydroxy(C1-C6 alkyl),
ORa,
Wherein Ra = C1-C6 alkyl, H, or hydroxy(C1-C6 alkyl),
5-6-membered heteroaryl, nitro,
NRaRb,
Wherein Ra and Rb each independently represent H, C1-C6 alkyl, and hydroxy(C1-C6 alkyl)
or -NH-(C0-C6 alkyl)-RM
Wherein RM = 6-membered heterocyclyl or 6-membered heteroaryl
Cy2 = a 5-8 membered saturated or unsaturated monocyclic or bicyclic ring
the 5-8 membered saturated or unsaturated monocyclic or bicyclic ring optionally contains 0-2 heteroatoms selected from O, N, and S; the Cy2 is optionally substituted with 0-3 substituents selected from the following: halogen, C1-6 alkyl, or OH
Note: Instant claim 1 does not state that Cy2 can be substituted with C1-6 alkyl. Instead, instant claim 1 states that Cy2 can be substituted with C1-C6 haloalkyl (and recites this twice, back-to-back). It seems as if one of the “C1-C6 haloalkyl” should have been written as “C1-C6 alkyl” instead. However, for this office action, Examiner still reads claim 1 as not allowing Cy2 to be substituted by C1-C6 alkyl.
As such, significant portions of the claimed structural space remain unexplored by the working examples. According to MPEP § 2163 (see above), a narrow subgenus of compounds does not adequately reflect a claimed genus that is structurally diverse. For example, in all the working examples provided in the instant specification:
RW1 = RW2 = R2 = H
and, therefore, cannot adequately represent compounds wherein:
RW1 = RW2 = R2 = halogen, cyano, nitro, hydroxy(C1-C6 alkyl), C1-C6 alkyl, C3-C8 cycloalkyl, C1-C6 haloalkyl, -ORa, -SO3Ra, -S(O)Ra, -O-, -SRa, -SF5, or -NRaRb.
Accordingly, the disclosed species do not adequately reflect the structural diversity of the claimed genus and do not demonstrate possession of the full scope of compounds recited in instant claims 1-3, 6, 10, 11, 13, 15-19, and 23.
Scope of Enablement
Claims 1-3, 6, 10, 11, 13, 15-19, and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
A compound having a structure of formula (I), or a pharmaceutically acceptable salt, stereoisomer, isotope isomer, hydrate, or solvate of the compound:
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wherein:
R1 =
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or L3 – R3
wherein L3 – R3 = -NRa-SO2-(C1-6 alkyl)
wherein Ra = H and C1-6 alkyl is optionally substituted with 0-3 OH
W1 = CRW1 or N
Wherein RW1 = H
W2 = CRW2 or N
Wherein RW2 = H
R2 = H
Z =
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L1 = 5-membered heteroaryl
Cy1 = phenyl or 6-10 membered heteroaryl
Wherein the Cy1 is optionally substituted with 0-3 substituents selected from the following:
halogen, C1-C6 alkyl, hydroxy(C1-C6 alkyl),
ORa,
Wherein Ra = C1-C6 alkyl, H, or hydroxy(C1-C6 alkyl),
5-6-membered heteroaryl, nitro,
NRaRb,
Wherein Ra and Rb each independently represent H, C1-C6 alkyl, and hydroxy(C1-C6 alkyl)
or -NH-(C0-C6 alkyl)-RM
Wherein RM = 6-membered heterocyclyl or 6-membered heteroaryl
Cy2 = a 5-8 membered saturated or unsaturated monocyclic or bicyclic ring
the 5-8 membered saturated or unsaturated monocyclic or bicyclic ring optionally contains 0-2 heteroatoms selected from O, N, and S; the Cy2 is optionally substituted with 0-3 substituents selected from the following: halogen, C1-6 alkyl, or OH
Note: Instant claim 1 does not state that Cy2 can be substituted with C1-6 alkyl. Instead, instant claim 1 states that Cy2 can be substituted with C1-C6 haloalkyl (and recites this twice, back-to-back). It seems as if one of the “C1-C6 haloalkyl” should have been written as “C1-C6 alkyl” instead. However, for this office action, Examiner still reads claim 1 as not allowing Cy2 to be substituted by C1-C6 alkyl,
does not reasonably provide enablement for elements that are outside the scope of the enabling elements listed above. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
As stated in the MPEP 2164.01(a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
In evaluating the enablement question, several factors are to be considered. According to In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988), these factors include:
1) The nature of the invention,
2) the state of the prior art,
3) the predictability or lack thereof in the art,
4) the amount of direction or guidance present,
5) the presence or absence of working examples,
6) the breadth of the claims, and
7) the quantity of experimentation needed to make and use the invention based on the content of the disclosure, and
8) the level of the skill in the art.
In the instant case, the Wands factors are relevant for the following reasons:
The nature of the invention
The nature of the invention claims a kinesin KIF18A inhibitor that regulates the KIF18A protein, influencing cell cycle and proliferation processes for the treatment of cancers and cancer-related diseases, along with its applications, are provided. Pharmaceutical compositions containing the compounds and their use as therapeutic agents, and methods for treating conditions associated with KIF18A activity are also provided.
The level of the skill in the art
The level of ordinary skill in the art is relatively high. A person of ordinary skill would typically have formal training in medicinal chemistry and organic synthesis and would be familiar with standard methods for evaluating therapeutic efficacy of compounds.
The presence or absence of working examples
The instant specification provides specific examples of compounds encompassed by instant claim 1 (see pg. 22-29 for structures).
The breadth of the claims
The claims are broad insofar as the instant claims recite a compound of instant formula I wherein the compound can possess a structurally diverse range of chemical substituents and substantially different core scaffolds.
State of the prior art and the predictability or lack thereof in the art; The amount of direction or guidance present; and the quantity of experimentation needed to make and use the invention based on the content of the disclosure
The quantity of experimentation needed to make or use the invention must be considered to determine if undue experimentation is present. With regard to quantity of experimentation needed, (note Wolff et. al., "Burger's Medicinal Chemistry and Drug Discovery," 5th Ed. Part 1, pp. 975-977 (1995) provided with this action), which emphasizes the many experimental factors for consideration for a successful prodrug as well as the difficulty in extrapolating data from one species to another. See p.975-977. “Extensive development must be undertaken to find the correct chemical modification for a specific drug. Additionally, once a prodrug is formed, it is a new drug entity and therefore requires extensive and costly studies to determine safety and efficacy.” Banker, et. al., (1996), Modern Pharmaceutics, p.596, section “B. Prodrugs”, last paragraph. In view of all these factors undue experimentation would be required to practice the invention.
The scope of prodrugs is not adequately enabled or defined. Applicants provide no guidance as how the compounds are made more active in vivo. The choice of a prodrug will vary from drug to drug. Therefore, more than minimal routine experimentation would be required to determine which prodrug moiety will be suitable for the instant invention. The application does not provide any guidance for one skilled in the art on how the prodrug is converted to active compounds, by what mechanisms and at what site the prodrug will be activated, what in vivo enzymes are likely involved in cleaving the protected group, etc.
Applicants provide no reasonable assurance that any and all known prodrugs will have the ability to regenerate in vivo to the instant compounds by one or more biological processes. It is not the norm that one can predict with any degree of accuracy a particular prodrug form of an active compound will be more soluble, more easily handled in formulations or more bioavailable without actual testing in vivo. Pursuant to In re Wands, 8 USPQ2d 1400, factors such as direction or guidance are not seen in the specification.
Many functional groups (e.g., hydroxy, amino groups) present in drugs are capable at least in theory to being derivatized but determining what is a prodrug and what is not requires knowledge of an intended effect (i.e. modification of an undesirable property in the parent drug- poor solubility, poor bioavailability, poor shelf-life) which is never identified by the specification.
Claim Rejections - 35 USC § 112(b)
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 1-3, 6, 10, 11, 13, 15-19, and 23 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.
Claims 1-3, 6, 10, 11, 13, 15-19, and 23 recite “prodrugs.” The term “prodrugs” render claims 1-3, 6, 10, 11, 13, 15-19, and 23 indefinite as “prodrugs” does not have a defined structure known in the art. For example, one would not be apprised of the pharmacologically inactive form of the claimed compound from the simple recitation of “prodrug” as the compound itself has multiple sites to which a prodrug moiety could bind. Moreover, one could not ascertain as to which prodrug moieties are within the scope of the claim, resulting in millions of combinations of prodrug moieties associated with the claimed compound at different locations on its structure. One could not possibly envisage all the possibilities of a prodrug of any compound of the instant invention. Likewise, a person of ordinary skill in the art would not be able to predict all possible structural forms of complexes based solely on the structure of the parent compound.
Claim 1 recites:
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(on pg. 270) and
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(on pg. 271).
However, the definitions of variables Y1, Y2, Y3, A and B are crossed out in claim 1 (see pg. 271, 2nd and 3rd line).
It is unclear whether Applicant intends to include or exclude the rings comprising variables Y1, Y2, Y3, A and/or B in claim 1.
Since the definitions of variables Y1, Y2, Y3, A and B are crossed out in claim 1, for this office action, Examiner also interprets the rings comprising variables Y1, Y2, Y3, A and/or B (on pg. 270 and 271 of claim 1) to be deleted. Therefore, Examiner interprets claim 1 to recite Z =
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only.
Claim 1 also recites:
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.
See pg. 271.
It is unclear whether Applicant intended to include or exclude the following as alternatives of L1:
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For this office action, Examiner interprets “
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” (which appears after “L1 represents 5-6-membered heteroaryl”) to mean that all alternatives after “5-6-membered heteroaryl” is deleted. Therefore, Examiner interprets claim 1 to recite “L1 represents 5-6-membered heteroaryl” only.
Claim 11 recites:
“wherein Z represents:
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It is unclear whether Applicant intended Z to be:
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, only, or
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or
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.
Consistent with what Examiner wrote above, Examiner will interpret “—” in
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to mean that all alternatives after the first
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is deleted. Therefore, Examiner interprets claim 11 to recite “wherein Z represents:
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” only.
Claim Rejections - 35 USC § 112(d)
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 6, 13, 15, 19, and 23 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.
Claim 6 recites: “…wherein R3 represents C1-C6 alkyl substituted with 0-3 substituents selected from halogen, -ORa, -NRaRb, cyano, and -O-C1-C6 haloalkyl.” Claim 6 is dependent on claim 1 which recites: “…wherein, R3 represents C1-C6 alkyl, wherein the C1-C6 alkyl is optionally independently substituted with 0-3 substituents selected from halogen and -ORa…” Claim 1 does not state that R3 can be substituted with -NRaRb, cyano, and -O-C1-C6 haloalkyl. Therefore, claim 6 fails to further limit the subject matter of the claim upon which it depends and, instead, broadens the scope of claim 1.
Note: Amending claim 6 by removing the “-NRaRb, cyano, and -O-C1-C6 haloalkyl” limitation would result in claim 6 being a substantial duplicate of instant claim 1. To avoid an objection, please ensure that claim 6 is amended properly such that it further limits the subject matter of claim 1.
Claim 13 fails to further limit the subject matter of the claim upon which it depends (i.e., instant claim 1) as explained in the table below.
Entry no.
Cy1 structure recited by claim 13
Location of Cy1 structure in instant claims
Substituent on Cy1 ring structure
Reason why claim 13 is rejected under 112(d):
1
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119
159
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Pg. 282, row 6, col. 3
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97
137
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Claim 13 is dependent on claim 1. However, claim 1 does not recite that Cy1 can be substituted with -C(=NH)-NH2. Therefore, claim 13 fails to further limit the subject matter of the claim upon which it depends and, instead, broadens the scope of claim 1.
2
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86
87
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Pg. 284, row 1, col. 3
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113
75
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Claim 13 is dependent on claim 1. However, claim 1 does not recite that Cy1 can be substituted with -N=CH2. Therefore, claim 13 fails to further limit the subject matter of the claim upon which it depends and, instead, broadens the scope of claim 1.
3
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60
79
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Pg. 284, row 1, col., 4
NA (this Cy1 is not a cyclic structure with a substituent)
Claim 13 is dependent on claim 1. However, claim 1 does not recite that Cy1 can possess a non-cyclic structure. Therefore, claim 13 fails to further limit the subject matter of the claim upon which it depends and, instead, broadens the scope of claim 1.
Claim 15 recites: “wherein L1 represents one of the following groups: …
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80
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…” Claim 15 is dependent on claim 1. As explained in the “Claim Rejections - 35 USC § 112(b)” section above: Examiner interprets claim 1 to recite “L1 represents 5-6-membered heteroaryl” only. Therefore, claim 1 does not recite that L1 can be
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80
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. Thus, claim 15 fails to further limit the subject matter of the claim upon which it depends and, instead, broadens the scope of claim 1.
Claim 19 fails to further limit the subject matter of the claim upon which it depends (i.e., instant claim 1) as explained in the table below.
Entry no.
Cy1 structure recited by claim 19
Location of Cy1 structure in instant claim 19
Substituent on Cy1 ring structure
Reason why claim 19 is rejected under 112(d):
1
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Pg. 286, row 1, col. 3 and
Pg. 286, row 3, col. 4
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164
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Claim 19 is dependent on claim 1. Claim 1 states that “Cy1 is optionally substituted with 0-3 substituents selected from the following:… 5-6 membered heteroaryl…” Claim 1 does not state that the 5-6 membered heteroaryl can be substituted. In the instant specification, it also does not state that a heteroaryl can be substituted (see pg. 31, last paragraph for definition of “heteroaryl”). Therefore, the Cy1 structure being substituted with a substituted 5-membered heteroaryl is not encompassed by instant claim 1. Thus, claim 19 fails to further limit the subject matter of the claim upon which it depends and, instead, broadens the scope of claim 1.
2
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137
99
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Pg. 286, row 3, col., 3
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179
164
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Same reason as example 1 above.
3
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102
126
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Pg. 287, row 1, col., 1
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179
164
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Same reason as example 1 above.
4
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94
135
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Pg. 287, row 1, col., 2
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179
164
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Greyscale
Same reason as example 1 above.
5
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106
126
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Pg. 287, row 1, col., 3
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148
143
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Greyscale
Same reason as example 1 above.
6
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102
126
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Pg. 287, row 1, col., 4
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139
135
media_image46.png
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Same reason as example 1 above.
7
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102
147
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Pg. 287, row 2, col., 1
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110
160
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Same reason as example 1 above.
8
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88
143
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Pg. 287, row 2, col., 2
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107
166
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Same reason as example 1 above.
9
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100
133
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Pg. 287, row 2, col., 3
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138
141
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Greyscale
Same reason as example 1 above.
10
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98
126
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Pg. 287, row 2, col., 4
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140
137
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Same reason as example 1 above.
11
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129
174
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Pg. 287, row 3, col., 1
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203
221
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Same reason as example 1 above.
12
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104
129
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Pg. 287, row 3, col., 2
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145
143
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Same reason as example 1 above.
13
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116
214
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Pg. 287, row 6, col., 3
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128
176
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(i.e., -C(O)NRaRb wherein Ra = H and Rb =
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164
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).
Claim 19 is dependent on claim 1. Claim 1 states that “Cy1 is optionally substituted with 0-3 substituents selected from the following:… -C(O)NRaRb…” Claim 1 does not state that Ra or Rb can be a substituted 5-membered heteroaryl. Therefore, the Cy1 structure being substituted with
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128
176
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is not encompassed by instant claim 1. Thus, claim 19 fails to further limit the subject matter of the claim upon which it depends and, instead, broadens the scope of claim 1.
14
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89
111
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Pg. 287, row 6, col., 4
=O
Claim 19 is dependent on claim 1. Claim 1 does not state that Cy1 can optionally be substituted with an oxo group (i.e., =O). Therefore, the Cy1 structure being substituted with an oxo group is not encompassed by instant claim 1. Thus, claim 19 fails to further limit the subject matter of the claim upon which it depends and, instead, broadens the scope of claim 1.
Claim 23 recites: “…wherein Cy2 represents…
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92
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…
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87
87
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…
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88
91
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…
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79
89
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…
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80
93
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…
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90
148
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.” Claim 23 is dependent on claim 1 which recites: “wherein, Cy2 represents a 3-12-membered saturated or unsaturated monocyclic or bicyclic ring, the 3-12-membered saturated or unsaturated monocyclic or bicyclic ring optionally contains 0-3 heteroatoms selected from O, N, and S; the Cy2 is optionally substituted with 0-3 substituents selected from the following: halogen, C1-C6 haloalkyl, C1-C6 haloalkyl, …” Claim 1 does not state that Cy2 can be substituted with C1-C6 alkyl. Claim 1 also does not state that Cy2 can be substituted with 4 substituents (i.e.,
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has four substituents). Therefore, claim 23 fails to further limit the subject matter of the claim upon which it depends and, instead, broadens the scope of claim 1.
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.
Note on 35 USC § 102 and § 103 Rejections
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Rejection Part 1:
Claims 1-3, 6, 10, 11, 13, 15, 16, 23, and 24 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by:
Zhang et al. (Zhang) (US 2025/0250264 A1)
This patent application claims the benefits of foreign priority to CN202210400226.5, filed on April 15, 2022.
One of the KIF18A inhibitors disclosed by Zhang is the following:
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365
576
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(see pg. 28, compound I-52; this compound is also identified as compound I-52 in the foreign priority document: CN202210400226.5, filed on April 15, 2022). Compound I-52 is encompassed by the instant claims wherein:
R1 = L3 – R3
L3 = -NRaSO2-
Ra = H
R3 = C2 alkyl substituted with 1 -ORa
Ra = H
W1 = CRW1
RW1 = H
W2 = CRW2
RW2 = H
R2 = H
Z =
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367
171
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Ra and Rb, together with an atom attaching to the Ra and the Rb, form a 3-membered saturated ring containing 0 heteroatoms
L1 = 5-membered heteroaryl (i.e.,
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191
249
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)
Cy1 = 6-membered heteroaryl substituted with 1 substituent
6-membered heteroaryl = pyridinyl
1 substituent = C1 alkyl
L2 = absence
Cy2 = 6-membered saturated monocyclic ring containing 1 N heteroatom and is substituted with 2 F (i.e.,
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294
201
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).
Compound I-52 of Zhang is the same as compound 24 in instant claim 24.
Therefore, compound I-52 of Zhang anticipates instant claims 1-3, 6, 10, 11, 13, 15, 16, 23, and 24.
Rejection Part 2:
Claims 1-3, 6, 10, 11, 15-17, and 23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by:
Zhang et al. (Zhang) (US 2025/0250264 A1)
This patent application claims the benefits of foreign priority to CN202210400226.5, filed on April 15, 2022.
One of the KIF18A inhibitors disclosed by Zhang is the following:
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358
570
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(see pg. 31, compound I-70; this compound is also identified as compound I-70 in the foreign priority document: CN202210400226.5, filed on April 15, 2022). Compound I-70 is encompassed by the instant claims wherein:
R1 = L3 – R3
L3 = -NRaSO2-
Ra = H
R3 = C2 alkyl substituted with 1 -ORa
Ra = H
W1 = CRW1
RW1 = H
W2 = CRW2
RW2 = H
R2 = H
Z =
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367
171
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Ra and Rb, together with an atom attaching to the Ra and the Rb, form a 3-membered saturated ring containing 0 heteroatoms
L1 = 5-membered heteroaryl (i.e.,
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206
295
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)
Cy1 = 6-membered heteroaryl substituted with 1 substituent
6-membered heteroaryl = pyridinyl
1 substituent = C1 alkyl
L2 = absence
Cy2 = 6-membered saturated monocyclic ring containing 1 N heteroatom and is substituted with 2 F (i.e.,
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294
201
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).
Therefore, compound I-70 of Zhang anticipates instant claims 1-3, 6, 10, 11, 15-17, and 23.
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.
Rejection Part 1:
Claims 1-3, 6, 10, 11, 13, 15, 16, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over:
Tamayo et al. (Tamayo) (WO2020132648A1; published June 25, 2020) and
Kumari et al. (Kumari) (Kumari, S. et al. Amide Bond Bioisosteres: Strategies, Synthesis, and Successes. J Med Chem. 2020, 63, 12290-12358.)
Similar to the instant invention, Tamayo discloses KIF18A inhibitors (see abstract). One of the KIF18A inhibitors disclosed by Tamayo is the following:
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(see Tamayo, pg. 79, para. 0312; herein, referred to as Tamayo-example-4).
Tamayo does not disclose a KIF18A inhibitor wherein the -NH-C(O)- moiety linking the pyrimidinyl and the phenyl ring is replaced with a triazole moiety. Kumari discloses that triazole is a bioisostere of an amide bond.
Kumari defines “isosteric or bioisosteric replacement” as the “process of replacement or modification of functional groups, having similar properties” (pg. 3, 2nd paragraph, last sentence). Kumari explains that lead drug compounds frequently exhibit deficiencies in potency, selectivity, pharmacokinetic properties, or pharmacodynamic properties that impede their development as clinical candidates. To address such deficiencies, Kumari teaches that “one of the most frequently employed strategies in hit to-lead and lead optimization involves the replacement of a selected fragment within a compound of interest with another fragment that is known to closely mimic the properties of the original fragment or functional group (pg. 3, 2nd paragraph, 2nd-to-last sentence). Specifically, Kumari teaches that the “triazole moiety has repeatedly shown potential application in refining the therapeutic ability of amide bond-containing molecules and therefore is considered an excellent nonclassical bioisostere” (pg. 4, last paragraph, 1st sentence). Figure 2 of Kumari (on pg. 78 of Kumari document and reproduced below) shows how the “1,4-disubstituted 1,2,3-triazole scaffold is isosteric to the trans amide bond and has gained widespread use” (pg. 4, last paragraph, last sentence which continues to pg. 5):
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1019
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.
Therefore, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the claimed invention to modify Tamayo-example-4 by replacing the -NH-C(O)- moiety with a triazole moiety to obtain the following compound:
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546
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(note: this compound is instant compound 89 which is recited in instant claim 24).
Instant compound 89 is a compound encompassed by instant claims 1-3, 6, 10, 11, 13, 15, 16, 23, and 24 wherein:
R1 = L3 – R3
L3 = -NRaSO2-
Ra = H
R3 = C2 alkyl substituted with 1 -ORa
Ra = H
W1 = CRW1
RW1 = H
W2 = CRW2
RW2 = H
R2 = H
Z =
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367
171
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Ra and Rb, together with an atom attaching to the Ra and the Rb, form a 3-membered saturated ring containing 0 heteroatoms
L1 = 5-membered heteroaryl (i.e.,
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177
272
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)
Cy1 = 6-membered heteroaryl substituted with 1 substituent
6-membered heteroaryl = pyrimidinyl
1 substituent = C1 alkyl
L2 = absence
Cy2 = 6-membered saturated monocyclic ring containing 1 N heteroatom and is substituted with 2 F (i.e.,
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294
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).
A POSITA would have had a reasonable expectation that the resulting compound (i.e., instant compound 89) would retain KIF18A-inhibitory activity because Kumari identifies 1,2,3-triazole as an amide bioisostere having similar properties and teaches its successful use in refining the therapeutic properties of amide-containing compounds.
Rejection Part 2:
Claims 1-3, 6, 10, 11, 13, 15-17, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over:
Zhang et al. (Zhang) (US 2025/0250264 A1)
This patent application claims the benefits of foreign priority to CN202210400226.5, filed on April 15, 2022.
One of the KIF18A inhibitors disclosed by Zhang is the following:
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570
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(see pg. 31, compound I-70; this compound is also identified as compound I-70 in the foreign priority document: CN202210400226.5, filed on April 15, 2022). Compound I-70 is encompassed by the instant claims as discussed above in “Rejection Part 2” of the “Claim Rejections - 35 USC § 102” section. Compound I-70 has a structure very similar to the structure of instant compound 25 (see instant claim 24 for structure):
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386
622
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. The main difference between compound I-70 and instant compound 25 is that in the latter compound, the moiety linking the phenyl and pyridinyl rings together is
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, whereas in compound I-70, that moiety is
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instead.
According to MPEP 2144.09:
I. REJECTION BASED ON CLOSE STRUCTURAL SIMILARITY IS FOUNDED ON THE EXPECTATION THAT COMPOUNDS SIMILAR IN STRUCTURE WILL HAVE SIMILAR PROPERTIES
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). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c).
II. HOMOLOGY AND ISOMERISM ARE FACTS WHICH MUST BE CONSIDERED WITH ALL OTHER RELEVANT FACTS IN DETERMINING OBVIOUSNESS
Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.).
Therefore, a person or ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to modify the
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moiety in compound I-70 (i.e., a KIF18A inhibitor) of Zhang to
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in order to obtain instant compound 25 (i.e., also a KIF18A inhibitor). A POSITA would have had a reasonable expectation that instant compound 25 would also be effective in being a KIF18A inhibitor since, absent of any data stating otherwise, position isomers are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. See MPEP 2144.09 (also pasted above).
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.
Claims 1-3, 6, 10, 11, 13, 15, 23, and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1, 9, 10, 12, 14, and 18-21 of U.S. Patent Application No. 18/865,350 (‘350) in view of:
Kumari et al. (Kumari) (Kumari, S. et al. Amide Bond Bioisosteres: Strategies, Synthesis, and Successes. J Med Chem. 2020, 63, 12290-12358.)
Instant claims 1-3, 6, 10, 11, 13, 15, 23, and 24 are generally encompassed by co-pending claims 1, 9, 10, 12, 14, and 18-21. The main difference between the two claim sets is that in the instant claims, L1 is interpreted to represent 5-6-membered heteroaryl only (see the “Claim Rejections - 35 USC § 112(b)” section above for explanation), whereas in the co-pending application, L1 can be -C(O)NH- or -HNC(O)-. However, -C(O)NH- or -HNC(O)- and a triazole ring (i.e., a 5-membered heteroaryl) are obvious variations of each other. A more detailed example is discussed below.
The co-pending application (‘350) discloses the following compound as a KIF18A inhibitor:
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(see claim 21, compound 63).
The co-pending application does not disclose a KIF18A inhibitor wherein the -C(O)-NH- moiety linking the quinoline and the phenyl ring is replaced with a triazole moiety. Kumari discloses that triazole is a bioisostere of an amide bond.
Kumari defines “isosteric or bioisosteric replacement” as the “process of replacement or modification of functional groups, having similar properties” (pg. 3, 2nd paragraph, last sentence). Kumari explains that lead drug compounds frequently exhibit deficiencies in potency, selectivity, pharmacokinetic properties, or pharmacodynamic properties that impede their development as clinical candidates. To address such deficiencies, Kumari teaches that “one of the most frequently employed strategies in hit to-lead and lead optimization involves the replacement of a selected fragment within a compound of interest with another fragment that is known to closely mimic the properties of the original fragment or functional group (pg. 3, 2nd paragraph, 2nd-to-last sentence). Specifically, Kumari teaches that the “triazole moiety has repeatedly shown potential application in refining the therapeutic ability of amide bond-containing molecules and therefore is considered an excellent nonclassical bioisostere” (pg. 4, last paragraph, 1st sentence). Figure 2 of Kumari (on pg. 78 of Kumari document and reproduced below) shows how the “1,4-disubstituted 1,2,3-triazole scaffold is isosteric to the trans amide bond and has gained widespread use” (pg. 4, last paragraph, last sentence which continues to pg. 5):
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.
Therefore, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the claimed invention to modify compound 63 of the co-pending application by replacing the -C(O)-NH- moiety with a triazole moiety to obtain the following compound:
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(note: this compound is instant compound 94 which is recited in instant claim 24).
Instant compound 94 is a compound encompassed by instant claims 1-3, 6, 10, 11, 13, 15, 23, and 24 wherein:
R1 = L3 – R3
L3 = -NRaSO2-
Ra = H
R3 = C2 alkyl substituted with 1 -ORa
Ra = H
W1 = CRW1
RW1 = H
W2 = CRW2
RW2 = H
R2 = H
Z =
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Ra and Rb, together with an atom attaching to the Ra and the Rb, form a 3-membered saturated ring containing 0 heteroatoms
L1 = 5-membered heteroaryl (i.e.,
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)
Cy1 = 10-membered heteroaryl (i.e., quinolinyl)
L2 = absence
Cy2 = 6-membered saturated monocyclic ring containing 1 N heteroatom and is substituted with 2 F (i.e.,
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).
A POSITA would have had a reasonable expectation that the resulting compound (i.e., instant compound 94) would retain KIF18A-inhibitory activity because Kumari identifies 1,2,3-triazole as an amide bioisostere having similar properties and teaches its successful use in refining the therapeutic properties of amide-containing compounds.
Thus, the instant claims represent an obvious variation of the claims of the co-pending application as they are directed to an obvious variation of the KIF18A inhibitors claimed in the co-pending application.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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