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 .
Priority
The instant application filed claims benefit to domestic provisional application No. 63/519,379 filed on August 14, 2023.
Status of Claims
Acknowledgement is made of original (1-2, 4, 7, 12, 19, 21, 25, 27, 30, 32-33, 45, 50-51), amended (3, 5-6, 8-11, 14-18, 20, 22-24, 26, 28-29, 31, 34-44, 46-49, 52), and cancelled (53-59) claims filed on December 2, 2024. Claims 1-52 are pending in instant application.
Information Disclosure Statement
The IDS statement filed June 24, 2026 has been considered.
Claim Interpretation
Instant claims 8-9 discuss limitations of R2b but do not require R2b to be present. Similarly, claim 14 discuses limitations of R10 but does not require R10 to be present. Claim 28 discusses limitations of R9b but does not require R9b to be present.
Accordingly if no R2b, R10, R9b is present in a prior art compound that reads on claim 1, the compound also reads on claims 8-9, 14, 28.
Claim Objections
Claims 18, 31-33, 35-44 objected to because of the following informalities:
Regarding claims 18, 31-33, 35-44, The claims recite redundant limitations. For example, claim 35 says “…are as defined in claim 1” twice, which is redundant since the claim already depends from claim 1, “The compound…according to claim 1”. Applicant does not need to re-specify limitations not further limited in the dependent claim. Similarly, re-referencing the parent claim for not further limited variables also occurs in claims 18, 31-33, 36-44 at least once.
Appropriate correction is required.
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 1-44, 46-52 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 claims 1-2, 6-7, 20-22, 30, 35-36, 38-44, the phrase "e.g." renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The follow is a non-exhaustive list of the use of e.g. in parentheses in the claims.
Claim 1 - e.g. fully saturated heterocyclyl, e.g. fluoro
Claims 2-14, 20-32, 34, 36, 38, 40, 42, 44, 46-52 depend from claim 1 and do not resolve the issues of indefiniteness and are thus included in instant rejection.
Claims 15-19, 33, 35, 37, 39, 41, 43 depend from claim 1 and only partially resolve one issue of indefiniteness (R2a) and are thus included in instant rejection.
Claim 2 - e.g. fully saturated heterocyclyl, e.g. fluoro
Claim 6 - e.g. fully saturated heterocyclyl
Claim 7 - e.g. fully saturated heterocyclyl
Claim 20 - e.g. fully saturated heterocyclyl
Claim 21 - e.g. fully saturated heterocyclyl
Claim 22 - e.g. fully saturated heterocyclyl, e.g. fluoro
Claim 30 – e.g. 0 (twice)
Claim 35 – e.g. 0 to 1, e.g. each Rsb is independently selected from O-C1-C3alkyl and 6 membered heterocyclyl comprising 1 heteroatom which is O
Claim 36 - e.g. fully saturated heterocyclyl, e.g. fluoro, e.g. 0 to 1, e.g. each Rsb is independently selected from O-C1-C3alkyl and 6 membered heterocyclyl comprising 1 heteroatom which is O
Claim 38 - e.g. fully saturated heterocyclyl, e.g. fluoro
Claim 39 - e.g. each Rsb is independently selected from O-C1-C3alkyl and 6 membered heterocyclyl comprising 1 heteroatom which is O
Claim 40 - e.g. fully saturated heterocyclyl, e.g. fluoro, e.g. each Rsb is independently selected from O-C1-C3alkyl and 6 membered heterocyclyl comprising 1 heteroatom which is O
Claim 41 - e.g. each Rsb is independently selected from O-C1-C3alkyl and 6 membered heterocyclyl comprising 1 heteroatom which is O
Claim 42 - e.g. fully saturated heterocyclyl, e.g. fluoro, e.g. each Rsb is independently selected from O-C1-C3alkyl and 6 membered heterocyclyl comprising 1 heteroatom which is O
Claim 43 - e.g. each Rsb is independently selected from O-C1-C3alkyl and 6 membered heterocyclyl comprising 1 heteroatom which is O
Claim 44 - e.g. fully saturated heterocyclyl, e.g. fluoro, e.g. each Rsb is independently selected from O-C1-C3alkyl and 6 membered heterocyclyl comprising 1 heteroatom which is O
For the purposes of applying art, any exemplary limitations are interpreted as not being required.
Further regarding claims 43-44, the phrase "(particularly R9a)" renders the claims indefinite because it is unclear whether the limitations following the phrase “particularly” are part of the claimed invention. See MPEP § 2173.05(d).
For the purposes of applying art, any preferred limitations are interpreted as not being required.
Regarding claims 31-33, claim 31 recites “wherein X, R1, R2, R3, R9b, and each R10 are as defined in claim 29” is confusing and unnecessary. Claim 29 does not define these variables, claim 1 does.
Claims 32, 33 have the same issue, the phrases “wherein X, R1, R2, R3, R9b and each R10 independently are as defined in claim 31” and “wherein R1, each R2b independently, R3, R9b, and each R10 independently are as defined in claim 32” are confusing an unnecessary. Claims 31 and 32 do not define these variables, claim 1 does.
The dependency of the claims establishes any not further limited variables, it is not necessary to refer to a parent claim twice in a dependent claim.
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.
Claim(s) 1-5, 8-11, 14, 23, 28, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN1.
Regarding claims 1-5, 8-11, 14, 23, 28, and a compound of formula I, STN teaches CAS# 2451098-20-5. CAS# 2451098-20-5 reads on instant formula I when X is CR6 and R6 is hydrogen (X is CH), R1 is hydrogen, R2 is R2a and R2a is hydrogen, R3 is hydrogen, R5 is
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, m is 0, R8 is hydrogen, R9 is R9a and R9a is hydrogen.
CAS# 2451098-20-5
Instant
Instant Claim 44
Formula XI
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Allowable Subject Matter
Claim 45 is allowed.
Claims 12-13, 15-19, 24-27, 29, 31-34, 37, 46-52, would appear to be free of the prior art if all 35 U.S.C. 112 issues were corrected.
Regarding claim 29-34, 37-38, 46-47 and Formulas Ic or Id or IV, the closest prior art appears to be FR 2761069 A1 to Halazy et. al.2 Halazy teaches CAS# 216577-02-5, which is structurally similar to the instantly claimed species (see Serge at p. 15 Exemple 1).
Halazy
CAS# 216577-02-5
Instant Claim 31
Formula Ic
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However, the species of Halazy differ from the instant application in connectivity, and notably differ from the instantly claimed genus in that they have spiro rings. No reasonable suggestion or motivation was found to modify a species of Halazy to remove the spiro rings and change the connectivity to arrive a species of instant application.
Regarding claims 35-36, 39-40 and Formulas II-III or VI-VII, the closest prior art is US 2007/0027163 A1 to Bissantz et. al.3 Bissantz teaches species such as CAS# 923295-46-9 (see Bissantz at p. 34 Example 42). CAS# 923295-46-9 is a structurally similar compound to instant Formula I wherein R5 is indole.
Bissantz
CAS# 923295-46-9
Instant Claim 36
Formula III
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However, CAS# 923295-46-9 contains a methoxy group in lieu of the instant –(C=O)NR2 moiety and differs in connectivity to the indole moiety. No reasonable suggestion or motivation was found to modify a species of Bissantz from methoxy to –(C=O)NR2 and change the connectivity to arrive at a species of instant application.
Regarding claims 41, 45-52 and Formula VIII and methods, the closest prior art is WO 2007/076423 A2 to Seefeld et. al.4 Seefeld teaches compounds and compositions for treating cancer and arthritis by inhibiting protein kinase B (see Seefeld at Abstract and claims 1, 9). Seefeld teaches CAS# 1236227-14-7 (see Seefeld at pp. 98-100 Example 31).
Seefeld
CAS# 1236227-14-7
Instant Claim 41
Formula VIII
Instant Claim 45 Species
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While CAS# 1236227-14-7 has an azaindole moiety as in instant Formula VIII, CAS# 1236227-14-7 notably differs in connectivity. No reasonable suggestion or motivation was found to modify a species of Seefeld to change the connectivity to arrive at a species of instant application.
Regarding claims 13, 43-44 and Formulas X-XI, the closest prior art is STN. Claim 44 requires R2a to be heterocyclyl, whereas CAS# 2451098-20-5 R2a is hydrogen. No reasonable suggestion or motivation was found in the art to modify CAS# 2451098-20-5’s hydrogen to a heterocyclyl. Claim 13 requires the indoline ring to be substituted with R10, which must be halo, and while an H for F swap might be obvious to an artisan developing a pharmaceutical compound, no known utility of CAS# 2451098-20-5 is disclosed by STN.
CAS# 2451098-20-5
Instant Claim 44
Formula XI
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Conclusion
Claim 45 is allowed.
Claims 18, 31-33, 35-44 are objected to.
Claims 1-44, 46-52 are rejected.
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/S.R./Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 CAS 2451098-20-5. CAS Registry File Accessed from STN and July 7, 2026, entered into STN July 28, 2020 (Year: 2020). Hereinafter STN.
2 Published September 25, 1998. Hereinafter Halazy.
3 Published February 1, 2007. Hereinafter Bissantz.
4 Published July 5, 2007. Hereinafter Seefeld.
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