DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Claims 1, 8, 17-22, 24-26, 37, 46, 48-49, 51, 55-56, 63-64, 75, 79-80, 83, 87, 89, 112-113, 117, 123, 125 and 142 are pending in the application as of the preliminary amendment submitted 05/22//2024. Claims 2-7, 9-16, 23, 27-36, 38-45, 47, 50, 52-54, 57-62, 65-74, 76-78, 81-82, 84-86, 88, 90-111, 114-116, 118-122, 124 and 126-141 are cancelled. Claims 1, 8, 17-22, 24-26, 37, 46, 48-49, 51, 55-56, 63-64, 75, 79-80, 83, 87, 89, 112-113, 117, 123, 125 and 142 are examined herein.
The compounds of formula (A) as in instant claim 1 have been found to be free of prior art.
In view of the pending claims, the following objections and rejections are made, as discussed below.
Priority
This application claims priority to PRO 63/593,454 filed 10/26/2023, PRO 63/585,565 filed 09/26/2023 and PRO 63/435,496 filed 12/27/2022.
The subject matter of claims 1, 8, 17-22, 24-26, 37, 46, 48-49, 51, 55-56, 63-64, 75, 79-80, 83, 87, 89, 112-113, 125 and 142 are supported by the ‘496 provisional application and accordingly, have an effective filing date of 12/27/2022. The subject matter of claims 117, 123 are supported in the ‘565 provisional application and accordingly, have an effective filing date of 09/26/2023.
Information Disclosure Statement
The information disclosure statement submitted on 05/22/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in Para. [0507], Para. [0513], Para. [0517] and Para. [0534] of the instant specification. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 117 and 123 are objected to because of the following informalities:
In claim 117, line 3 and line 8, there should be a “to” between “subsequent” and “the compound”. Claim 123 depends from claim 117 and is thus objected to.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 83 and 89 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 83, the claim depends from claim 75 and recites “(a) the subject comprises a solid tumor “; “(b) the subject comprises at least one of: melanoma, colon cancer, …”; “(c) the subject comprises at least one of: pulmonary fibrosis, …”. Para. [0302] of the instant specification defines “a subject” to mean a mammal. The use of the phrase “subject comprises” renders the scope of the claim unclear. Further, the use of the open ended transitional phrase “comprises” is inclusive or open-ended and does not exclude additional recited elements or method steps. See MPEP 2111.03 (I). Therefore, the metes and bounds of the claim are indefinite.
For the purpose of applying prior art, claim 83 has been interpreted to read “(a) the subject [[comprises]]has a solid tumor “; “(b) the subject [[comprises]]has at least one of: melanoma, colon cancer, …”; “(c) the subject [[comprises]]has at least one of: pulmonary fibrosis, …”. This is supported by Para. [0514] of the instant specification.
Regarding claim 89, the claim depends from claim 87 and recites “(b) the subject comprises melanoma, colon cancer, …”. Para. [0302] of the instant specification defines “a subject” to mean a mammal. The use of the phrase “subject comprises” renders the scope of the claim unclear. Further, the use of the open ended transitional phrase “comprises” is inclusive or open-ended and does not exclude additional recited elements or method steps. See MPEP 2111.03 (I). Therefore, the metes and bounds of the claim are indefinite.
For the purpose of applying prior art, claim 89 has been interpreted to read “the subject [[comprises]]has at least one of melanoma, colon cancer, …”. This is supported by Para. [0514] of the instant specification.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 125 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 125, the claim depends from claim 112 and claim 1, which is improper. Claim 112 depends from claim 1 and includes all the limitations of claim 1.
A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. See MPEP 608.01(n). Thus the inclusion of “the compound of claim 1” is redundant.
Claim 125 may be amended to read “The method of claim 112, wherein the effective amount of the compound [[of claim 1]], or a pharmaceutically acceptable salt thereof, is a therapeutically effective amount”.
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.
Allowable Subject Matter
The compounds of formula (A) as in claim 1 and the compounds of claim 46 have been found to be free of prior art. Except for the objections and rejections discussed above, all claims would be allowable.
The following is a statement of reasons for the indication of allowable subject matter:
The instant application relates to a compound of general formula A or a pharmaceutically acceptable salt thereof, with variables as defined in instant claim 1, a pharmaceutical composition, a kit, and methods of use of the compound of formula A thereof.
The closest prior art of record is Cha et al. (US 2020/0109141 A1, 09 April 2020, hereinafter Cha, in the IDS). Cha teaches compounds of formula (I) or a salt thereof as inhibitors of αvβ1, integrin and αvβ6 integrin and methods of use thereof (Abstract; Paras. [0476]-[0482]).
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Cha teaches the exemplary compounds, Compound 66 (example 82) (Para. [0764]; Pg. 4, FIG. 1) and Compound 160 (example 206) (Para. [1033]; Pg. 10, FIG. 1) shown below.
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Compound 66 and Compound 160 of Cha overlaps the core structure of instant formula (A), wherein
R1 is 5,6,7,8-tetrahydro-1,8-naphthyridin-2-yl;
R2 and R3 together with the carbon atom to which they are attached form a C3 cycloalkyl (cyclopropyl);
Compound 66 and Compound 160 of Cha differs in R4 being a phenyl/isoquinolinyl versus a 5-to 6- membered heteroaryl as required by the instant claims and the linker -L1-O-L2-Y-L3- being
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versus the instantly claimed
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.
While Cha teaches embodiments in which G can be -C(O)R2 as an option, R2 can be C3-C8 cycloalkyl optionally substituted by R2b as an option, R2b can be R4 as an option, R4 can be 5- to 10-membered heteroaryl as an option [Paras. [0072]-[0073]; Paras. [0081]-[0082]) and the linker may be
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as an option (Para. [0106]), there is too much picking and choosing in going from the compounds of Cha to arrive at the compounds of the instant invention. Therefore, the instant compounds are novel and non-obvious over the closest prior art of record.
Conclusion
Claims 83, 89 and 125 are rejected.
Claims 117 and 123 are objected to.
Claims 1, 8, 17-22, 24-26, 37, 46, 48-49, 51, 55-56, 63-64, 75, 79-80, 87, 112-113 and 142 are allowed.
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/PADMAJA S RAO/Examiner, Art Unit 1627