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 .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to claims 1, 3, 8, 11, 24, 35-37, 42, 46, 57-58, 63, and 65-67 in the reply filed on 09/01/2026 is acknowledged. It is additionally acknowledged that claim 2 was previously canceled and is not included in this examination. Further, Applicant’s election without traverse of the following compound, drawn to claims 1, 3, 8, 11, 24, 37, 42, 46, 57, 58, 66, and 67, in the reply filed on 09/01/2026 is acknowledged:
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Examiner respectfully notes that the above compound is designated as I-34 in the reply filed on 09/01/2026; however, it is designated as I-334 in the Instant Specification (page 294) and will be referred to as such hereinafter.
Claims 35-36, 63, 65, 68-71 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/01/2026.
After a careful review of the prior art, the elected species I-334 is free of the prior art. A claim directed to compound I-334 in independent form would be allowable over the prior art. The Examiner has expanded the search to include Formula I and subsequent examination is based on this species expansion.
Status of the Claims
The status of the claims are as follows:
Claims 1, 3, 8, 11, 24, 35-37, 42, 46, 57-58, 63, and 65-71 are pending.
Claims 35-36, 63, 65, 68-71 are withdrawn.
Claims 1, 3, 8, 11, 24, 37, 42, 46, 57, 58, 66, and 67 are rejected
Priority
Acknowledgement is made that Instant Application 18/752,702, filed on 06/24/2024, claims benefit from Provisional Application 63/510,039, filed on 06/23/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/20/2025 and 09/01/2026 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections – Improper Markush Grouping
Claims 1, 3, 8, 11, 24, 37, 42, 46, 57, 58, 66, and 67 are rejected on the 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). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of the claims is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
The claims are directed to compounds of Formula I, or a pharmaceutically acceptable salt thereof,
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wherein PBM, L, and DIM may be any of a very large number of patentably distinct functional groups, which do not in their current form present any common chemical structure that can be attributed to the asserted utility of the compounds. See claim 1.
The claims of Formula (I) do not share a single structural similarity regarding PBM in the Markush group. Moiety PBM is defined as an Akt binding moiety thereby forming a compound of Formula I-a’
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Formula I-a’ is comprised of at least three different ring systems, each of which can fall within different classes. For example, rings A and B are independently fused and may be selected from, for example, a 4-7 membered saturated carbocyclyl. Meanwhile, Ring C, may be selected from, for example, a partially unsaturated bridged bicyclic heterocyclylenyl with 1-3 heteroatoms. Meanwhile, Ring D may be selected from, for example, a phenyl. See claims 3, 8, and 11. Each of the provided examples are distinct functional groups that fall within different patent classes. The claims additionally do not recite any compound as a preferred embodiment of Formula I-a’.
Additionally, the claims of Formula I do not share a single structural similarity regarding DIM in the Markush group. Moiety DIM is defined as a deubiquitinase binding moiety (DBM), which is drawn to 12 different formulae. See claim 24. A non-exhaustive list of disclosed DIM alternatives is shown below, with each example being directed to a different patent class.
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The structure of deubiquitinase binding moiety is directly relevant to its function. For example, Sprott (WO 2022/272133 A2, published 12/29/2022) teaches a class of USP7 targeting ligands include
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, while Sprott (WO 2023/122298 A1, published 06/29/2023) teaches compounds that target USP28 and USP25, including
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To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112
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.
Claim 1 is 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. Specifically, the claim is directed to a protein binding moiety capable of binding Akt.
There is insufficient written description for this claim limitation in the disclosure. M.P.E.P. § 2163 states:
"An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention...one must define a compound by 'whatever characteristics sufficiently distinguish it'. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process."
To provide adequate written description of a claimed genus, the specification must describe sufficient distinguishing identifying characteristics of binding Akt. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, structure/function correlation, methods of making the claimed compounds or any combination thereof.
It is generally accepted in the art that Akt has multiple, well-defined binding regions with no universal binding structure. For example, Morrow (Recent Development of Anticancer Therapeutics Targeting Akt. Recent Pat. Anticancer Drug Discov. 2011, 6(1), 146-159. Doi: 10.2174/157489211793980079) teaches isoforms of the Akt family are characterized by an amino terminal pleckstrin-homology (PH) domain, a kinase domain, a linker domain connecting the two, and a C-terminal regulatory domain. The most common Akt target is the central kinase domain with structurally related inhibitors, for example A-443654, GSK690693, and XL418 (Table 1).
ATP Binding Site Inhibitor
A-443654
GSK690693
XL418
Structure
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However, targeting other sites, such as the T-loop of the kinase domain, the PH domain, or the Link domain requires compounds that are structurally distinct from those above (Table 2).
Akt Target
T-loop of kinase domain
PH domain
Link Domain
Name
WAY-178210-A-1
Perifosine
Merck-Akt-I-2
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One of ordinary skill in the art would not expect, for example, a compound that binds the PH domain to have the same physical and chemical characteristics as a compound that binds the kinase domain. Accordingly, Akt inhibitors encompass broad structural and binding site variability that a skilled artisan could not readily predict.
While it is recognized that adequate written description of a limitation is not required to be stated in haec verba in the specification or claims as originally filed, adequate written support for all claim limitations must arise from either an explicit or an implicit suggestion by the disclosure to show that such a concept as now claimed was actually in possession of the Applicant at the time of the invention.
In the Instant case, the specification positively recites compounds that resemble ATP binding site inhibitors of Akt, for example, compounds of formula I-b (page 15, paragraph 0050)
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However, the Instant specification fails to teach compounds that may bind any other site. The lack of presented examples is not considered representative of the exceedingly vast number of possible Akt binding moieties that are encompassed by the claims.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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, 8, 11, 57, 58, 66, and 67 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. Specifically, the phrase “deubiquitination inducing moiety” renders the scope of the claim ambiguous.
The above phrase renders the scope of the claim ambiguous because it allows for multiple interpretations. For example, ubiquitination homeostasis of insulin-like growth factor 2 messenger RNA (mRNA)-binding protein 2 (IGF2BP2) is dynamically regulated by the opposing actions of USP9X deubiquitinase and WWP1 E3 ligase (see Xia (The Deubiquitinase USP9X and E3 Ligase WWP1 Orchestrate IGF2BP2 Ubiquitination Homeostasis to Drive TNBC Progression and Cisplatin Sensitivity. Cell Death Dis, 2025, 16, 703. Doi 10.1038/s41419-025-08038-5). Therefore, deubiquitination of IGF2BP2 is induced by WWP1 ligase activity. As such, some ligands that induce ubiquitination fall within the presently claimed term “deubiquitination inducing moiety”, rendering the claim scope unclear. Furthermore, the Instant specification fails to provide a definition of the phrase “deubiquitination inducing moiety.” Accordingly, the metes and bounds of the claimed invention are unclear.
Claim Rejections – 35 USC § 103
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.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Sprott (WO 2022/272133 A2. Published 12/29/2022; Priority claim to Provisional Application 63/215,405, filed on 06/24/2021) in view of Stevers (Characterization and Small-Molecule Stabilization of the Multisite Tandem Binding Between 14-3-3 and the R domain of CFTR, Proc. Natl. Acad. Sci USA, 2016, 113, E1152-E1161. Doi: 10.1073/pnas.1516631113) as evidenced by Powell (Identification of 14-3-3ζ as a Protein Kinase B/Akt Substrate. Journal of Biological Chemistry, 2002, 277, 21639-21642. Doi: 10.1074/jbc.M203167200).
Claim 1 is directed to compounds of Formula I, or a pharmaceutically acceptable salt thereof:
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wherein
PBM is a protein binding moiety capable of binding Akt;
L is a bivalent moiety that connects PBM to DIM; and
DIM is a deubiquitination inducing moiety.
Sprott teaches protein stabilizing compounds, compositions, and methods of use thereof, that include a USP7 targeting ligand, a protein targeting ligand, and optionally a linker for the restoration of a target ubiquinated protein to treat a disorder mediated by deficiencies of the target protein (abstract). The protein stabilizing compounds are of general Formula II (page 4, lines 15-28), or a pharmaceutically acceptable salt thereof
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wherein
The ubiquitinated protein targeting ligand is a ligand that binds a target ubiquitinated protein;
The linker is a bond or a bivalent moiety that links the protein targeting ligand and the USP7 targeting ligand; and
The USP7 targeting ligand is a ligand that targets deubiquitinase USP7.
Sprott further teaches the ubiquitinated protein targeting ligand may be a pharmaceutically active compound or a fragment thereof that binds to the target ubiquitinated protein (for example an approved drug or a compound in development with known binding affinity for the target ubiquitinated protein in either the ubiquitinated or nonubiquitinated form (page 12, lines 13-18).
The difference between the above teaching and the Instant Application is that Sprott fails to teach where the ubiquitinated protein targeting ligand is a ligand that binds to Akt ubiquitinated protein.
However, Stevers teaches the 14-3-3 protein binds to the CFTR regulatory domain and enhances CFTR trafficking to the plasma membrane (abstract). Of the 14-3-3 protein family, 14-3-3γ binds the strongest followed by η, β, ζ, e, τ, and σ, respectively (page E1154, left column, paragraph 1).
One of ordinary skill in the art would have been motivated to combine the teaching of Sprott with the teaching of Stevers as evidenced by Powell because they teach the same field of endeavor of targeting at least CFTR proteins. Additionally, Sprott points to the teaching of Stevers to provide additional examples of ligands to bind a target ubiquitinated protein (page 18, lines 28-30). Accordingly, said artisan would have found it prima facie obvious to apply prong (B) of the KSR rationale to arrive at a compound comprised of [14-3-3ζ protein targeting ligand]–Linker–[USP7 targeting ligand]. Because the 14-3-3ζ protein is an Akt substrate (see Powell), a compound of the described arrangement reads on the instant claim.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sprott in view of Cao (Role of K63-Linked Ubiquitination in Cancer. Cell Death Discovery, 2022, 8. Doi: doi.org/10.1038/s41420-022-01204-0).
Hereinafter is a rejection of claim 1 under 35 U.S.C. 103 that is separate from the above rejection of claim under 35 U.S.C. 103.
The teaching of Sprott are discussed above and incorporated herein by reference.
Sprott further teaches that USP7 can cleave at least 5 of the major polyubiquitin bonds, including K63-linked modifications (page 3, lines 7-8).
The difference between Sprott and the Instant Application is that Sprott fails to teach the specific ubiquitinated protein target is Akt.
However, Cao teaches the role of K63-linked ubiquitination in controlling the initiation, development, invasion, metastasis, and therapy of diverse cancers (abstract). A number of signaling pathways are often altered in tumorigenesis, including PI3K/Akt signaling (page 2, left column, paragraph 2). The K63-linked polyubiquitination and activation of Akt has been found to initiate tumorigenesis (page 2, left column, paragraph 3).
One of ordinary skill in the art would have been motivated to combine the above teachings because they teach the same field of endeavor of targeting deubiquitination pathways to modulate protein levels for the treatment of cancer. Said artisan would have had a reasonable expectation of success to use the conjugated moieties of Sprott with an Akt targeting ligand to treat K63-linked ubiquitination cancers, thus arriving at the current invention.
Claim(s) 3, 8, 11, 24, 37, 42, 46, 57-58 and 66-67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sprott in view of Cao in view of Mitchell (WO 2008/006040 A1. Published 01/10/2008).
The teachings of Sprott in view of Cao are discussed above and incorporated herein by reference
Claim 3 is directed to compounds of Formula I, wherein PBM is an Akt binding moiety thereby forming a compound of Formula I-a’ or a pharmaceutically acceptable salt thereof
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The difference between the teachings of Sprott in view of Cao and the Instant Application is the combined teachings fail to teach an Akt binding moiety that is derived of Formula I-a’.
However, Mitchell teaches compounds, including resolved enantiomers, resolved diastereomers, solvates, and pharmaceutically acceptable salts thereof and their methods of use as AKT protein kinase inhibitors for the treatment of hyperproliferative diseases, such as cancer (abstract). Mitchell provides at least Example 5, as an Akt binding moiety that is encompassed by Formula I-a’ (page 87, line 1)
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One of ordinary skill in the art would have been motivated to combine the teaching of Mitchell with the combined teaching of Sprott in view of Cao because they teach the same field of endeavor of targeting Akt for the treatment of cancer. The combined teachings of Sprott in view of Cao render it prima facie obvious to treat e.g., cancer by targeting Akt for deubiquitination, but fail to teach any specific Akt binding ligands to do so. One of ordinary skill in the art would have had a reasonable expectation of success in using the Akt inhibitors taught by Mitchell, such as Example 5, to act as the Akt binding ligand.
Claims 8 and 11 are directed to compounds of Formula I-a’, wherein Ring D is phenyl and Ring C is
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, wherein X1 and X2 are independently carbon or nitrogen
Example 5 of Mitchell comprises a phenyl as ring D and
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as Ring C, wherein both X1 and X2 are nitrogen.
Claim 24 is directed to compounds of Formula I-a’, wherein DIM is a deubiquitinase binding moiety (DBM), thereby forming a compound or a pharmaceutically acceptable salt of one of 12 different formulae, including Instant Formula I-cc:
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A non-limiting example of a deubiquitinase binding moiety rendered obvious by Sprott is shown below as compound I (page 29, row 2):
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Compound I reads on at least Instant Formula I-cc when:
LB is a straight C1 hydrocarbon chain, wherein 1 methylene units is replaced by -O-;
Ring X is 6-membered heteroarylenyl with 1 heteroatom selected as nitrogen;
L2 is a bond;
Ring Y is a 6-membered heteroarylenyl with 1 heteroatom selected as nitrogen;
(Ry)y is two, wherein one of Ry is selected as NR2, wherein both R is H and the other of Ry is RB, wherein RB is C2 aliphatic;
Ring Z is phenyl
(Rz)Z is one, wherein Rz is -OR, wherein R is H.
Claim 37 is directed to the compounds of claim 24, wherein Ring Y is selected from the group consisting of phenylenyl,
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Sprott further teaches compound I-a, which reads on Formula I-gg:
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at least when:
LB is a straight C1 hydrocarbon chain, wherein 1 methylene units is replaced by -O-;
Ring Y is phenylenyl;
L1’ is a covalent bond;
Ring Z is a 6-membered heteroaromatic ring with 1 heteroatom selected as nitrogen;
Subscript z of (Rz)z is selected so that z = 3;
One of Rz is selected as RB, wherein RB is selected as an optionally substituted 6-membered heteroaryl ring having 1 heteroatom selected from nitrogen, wherein the substituted 6-membered heteroaryl ring is substituted with OH;
Another of Rz is selected as -NR2, wherein both R are selected as hydrogen; and
The final Rz is selected as RB, wherein RB is selected as C2 aliphatic.
In the case described above, Ring Y is selected as phenylenyl.
Claim 42 is directed to compounds of claim 24, wherein ring Z is a phenyl or cyclopropyl.
Compound 1 comprises a phenyl as Ring Z.
Claim 46 is directed to compounds of claim 24, wherein said compound is a compound of any of the provided formulae.
Compound I reads on Formula I-cc-1:
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Claims 57-58 are directed to compounds of Formula I-a’ of claim 3, wherein L is selected as a group from the provided list, wherein L is selected from -C(O)-, CH2-Cy-CH2-Cy-, -C(O)-CH2-Cy-O-Cy-, -C(O)-CH2-Cy-, -Cy-CH2-Cy, and -Cy-O-Cy-.
Sprott teaches suitable linkers include
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(page 140, middle). A prima facie case of obviousness may be made when chemical compounds have very close structural similarities (e.g., positional isomers and homologs) and similar utilities. As stated by MPEP 2144.09:
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).
In the present case, the resulting linker
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when CH2 = 0 differs only from the instantly claimed linker -C(O)- by a single CH2 unit. Accordingly, the linker
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is an obvious homolog of the linker -C(O)-.
Claims 66 and 67 are directed to pharmaceutical compositions comprising a compound of claim 1 and a pharmaceutically acceptable carrier, adjuvant, and vehicle, and further comprising an additional therapeutic agent.
Sprott teaches pharmaceutical compositions comprising an effective amount of protein stabilizing compound or its pharmaceutically acceptable salt together with at least one pharmaceutically acceptable carrier, and further teaches the compositions may include at least one additional active agent (page 83, lines 14-18).
Conclusions
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paul Arcoria whose telephone number is (571)272-8719. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
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/P.A./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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