DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims and Response to Restriction Requirement
Claims 1-10, 12-20 and 23 are pending as of the response filed 04/01/2026. Claims 11, 21-22 and 24-26 are cancelled. Applicant’s election of group I claims 1-10 and 12-19 without traverse is acknowledged. Claims 20 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election of a species of compound, Compound 20, shown below without traverse is acknowledged.
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Claims 1-4, 9-10, 12-13 and 19 encompass the elected species. Claims 5-8 and 14-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.
Therefore, claims 1-4, 9-10, 12-13 and 19 have been examined to the extent to which they are readable on the above identified elected species.
The elected species was examined and was found to be free of prior art. The following prior art that anticipates the Markush compound of formula (I) as in claim 1 was found, as discussed below.
Priority
This application is a 371 of PCT/US2022/012926 filed 01/19/2022, which claims priority to PRO 63/139,555 filed 01/20/2021.
The subject matter of claims 1-4, 9-10, 12-13 and 19 are supported by the ‘555 provisional application and accordingly, have an effective filing date of 01/20/2021.
Information Disclosure Statement
The information disclosure statement submitted on 07/19/2023 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 on Pg. 64, Ln. 10 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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 9-10, 12 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites “R17 and R18 are each independently selected from hydrogen, deuterium, C1-12 alkyl, … optionally substituted C3-C8 cycloalkyl …”. The instant specification defines alkyl to refer to “straight chain and branched alkyl groups and cycloalkyl groups having from 1 to 40 carbon atoms” (Pg. 10, Lns. 6-8 of the instant specification).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05 (c). In the present instance, claim 1 recites the broad recitation C1-12 alkyl for the variables R17 and R18, and the claim also recites optionally substituted C3-C8 cycloalkyl as an option for R17 and R18 (note that cycloalkyl is encompassed by the definition of C1-12 alkyl) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
For the purpose of applying prior art, claim 1 has been interpreted with the broader limitation of C1-12 alkyl for the variables R17 and R18 as an option, without the narrower optionally substituted C3-C8 cycloalkyl appearing in the claim.
Regarding claim 9, the claim depends from claim 1 and recites “R37 and R38 are each independently selected from hydrogen, deuterium, optionally substituted C1-12 alkyl (see 35 U.S.C. 112(d) rejection below), … optionally substituted C3-C8 cycloalkyl …”. The instant specification defines alkyl to refer to “straight chain and branched alkyl groups and cycloalkyl groups having from 1 to 40 carbon atoms” (Pg. 10, Lns. 6-8 of the instant specification).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05 (c). In the present instance, claim 9 recites the broad recitation C1-12 alkyl for the variables R37 and R38, and the claim also recites optionally substituted C3-C8 cycloalkyl as an option for R37 and R38 (note that cycloalkyl is encompassed by the definition of C1-12 alkyl) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
For the purpose of applying prior art, claim 9 has been interpreted with the broader limitation of C1-12 alkyl for the variables R37 and R38 as an option, without the narrower optionally substituted C3-C8 cycloalkyl appearing in the claim.
Claims 2-4, 10, 12 and 19 are similarly rejected because they depend from the rejected base claim and do not remedy the indefiniteness.
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.
Claim 9 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 9, the claim depends from claim 1 and recites “R37 and R38 are each independently selected from hydrogen, deuterium, optionally substituted C1-12 alkyl, …”. The variables R37 and R38 correspond to R17 and R18 of claim 1. However, claim 1 does not recite “optionally substituted” C1-12 alkyl. This broadens the scope of the claim 9, which is improper.
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.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 9-10 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bhagwat et al. (US 2002/0103229 A1, hereinafter Bhagwat, in the IDS).
Regarding instant claim 1, Bhagwat teaches indazole derivatives having the following structure (I) (Para. [0013]).
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Bhagwat teaches the exemplary compound of Example 72, 3-(4-Fluorophenyl)-5-Pyrazol-3-Y1-1H-Indazole (Para. [0409]).
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Example 72 falls within the scope of formula (I) of instant claim 1, wherein
R10 is hydrogen;
R11 is absent;
R12 is substituted C6 aryl (4-fluorophenyl);
R13 is C5 heteroaryl (pyrazol-3-yl).
Example 72 of Bhagwat further reads on the limitations of instant claim 2 ( R12 is phenyl substituted with a halogen).
Bhagwat teaches the exemplary compound of Example 80, 4-{[3-(4-Fluorophenyl)-1H-Indazol-5-yl]Carbonylamino} Benzoic Acid (Para. [0437]).
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Example 80 falls within the scope of formula (I) of instant claim 1, wherein
R10 is hydrogen;
R11 is absent;
R12 is substituted C6 aryl (4-fluorophenyl);
R13 is
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;
R14 is hydrogen;
n is 1, R15 is -CO2H.
Example 80 of Bhagwat further reads on the limitations of instant claim 2 (R12 is phenyl substituted with a halogen), claim 4 (satisfies subsection (i)), claim 9 (R30 is hydrogen; R31 is absent; R32 is substituted C6 aryl (4-fluorophenyl); R34 and R35 are each hydrogen; R36 is -CO2H), claim 10 (R32 is phenyl substituted with a halogen).
Bhagwat teaches the exemplary compound of Example 171, 1-(5-(1H-1,2,3,4-Tetraazol-5-yl)(1H-Indazol-3-yl))-4-Methoxybenzene (Para. [0829]).
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Example 171 falls within the scope of formula (I) of instant claim 1, wherein
R10 is hydrogen;
R11 is absent;
R12 is substituted C6 aryl (4-methoxyphenyl);
R13 is C5 heteroaryl (tetrazolyl).
Example 171 of Bhagwat further reads on the limitations of instant claim 2 (R12 is phenyl substituted with C1 alkoxy), claim 3 (R12 is
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).
Bhagwat teaches the compounds formulated as a pharmaceutical composition
which contains an effective dosage amount of one or more of such compounds in combination with one (or more) pharmaceutically acceptable carrier(s) (Para. [0015]). Thus, Bhagwat anticipates the limitations of claim 19.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN 1349590-84-6 (1 of 24), entered 06 December 2011; RN 1349225-27-9 (9 of 24), entered 05 December 2011 and RN 1349004-38-1 (11 of 24), entered 05 December 2011.
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The database registry compounds fall within the scope of formula (I) of instant claim 1, wherein
R10 is hydrogen;
R11 is absent;
R13 is -C(=O)NHR16;
R16 is C3 alkyl (isopropyl) or C4 alkyl (sec-butyl);
R12 is substituted aryl (1/24), substituted heteroaryl (9/24); unsubstituted heteroaryl (11/24).
Allowable Subject Matter
The compounds of claim 13 are free of prior art. Claim 13 is objected to as being dependent from a rejected base claim.
Miscellaneous
The examiner would like to bring Applicant’s attention to the following:
A power of attorney document is not present in the application file.
An inventor’s oath or declaration signed by the inventors is not present in the application file.
Conclusion
Claims 1-4, 9-10, 12 and 19 are rejected.
Claim 13 is objected to.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached 9:00-5:30pm EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PADMAJA S RAO/Examiner, Art Unit 1627
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