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
Per Applicant’s amendment to the claims, submitted on 11/19/2024, claims 8-9 are amended, and claims 10-20 are canceled. Currently, claims 1-9 are pending in the instant application.
Priority
The instant application is a 371 of PCT/US2023/022912 filed on 05/19/2023, and claims priority to provisional application 63/344,233 filed on 05/20/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/19/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112 – Second Paragraph
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 2, 4, and 9 is 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.
Claim 2 is indefinite for reciting the compound of claim 1 wherein “R10 is hydrogen”, because a person of ordinary skill in the art would not reasonable be able to understand the metes and bounds of the claim. Parent claim 1 does not recite R10 as hydrogen. Accordingly, the instant claim provides a broader limitation for R10 and provides improper antecedence to the parent claim.
Claim 4 is indefinite for reciting the compound of claim 1 wherein “R10 is hydrogen”, because a person of ordinary skill in the art would not reasonable be able to understand the metes and bounds of the claim. Parent claim 1 does not recite R10 as hydrogen. Accordingly, the instant claim provides a broader limitation for R10 and provides improper antecedence to the parent claim.
Claim 9 is indefinite for reciting the phrase “preventing sickle cell disease”, because a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim. By reciting the term “preventing”, the instant claim encompasses a population of patients having sickle cell disease as well as those not having sickle cell disease. As the instant claim would essentially encompasses all people, it is unclear what the target population is.
Claim 9 is indefinite for reciting the phrase “or related condition”, because a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim. The recitation of a “related condition” is unclear as to what conditions would be encompassed by the claim.
Claim Rejections - 35 USC § 112 – First Paragraph
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.
Claims 1-4 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 compounds SCAS2_01 and SCAS2_05, does not reasonably provide enablement for the full structural genera of the formulas of claims 1-4. 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 use of the invention commensurate in scope with these claims.
Claims 1-4 provide the following formulas, respectively:
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Support for the claimed structures appears to be provided in specification pages 10-17, wherein the relevant formulas are described alongside working example compounds. However, only two example compounds appear to have been provided:
2-(3-(5-chloro-2-methoxyphenyl)ureido)-N,N- dimethyl-6,7-dihydrothiazolo[5,4-c]pyridine-5(4H)-sulfonamide (SCAS2_01)
1-(5-chloro-2-methoxyphenyl)-3-(5- (cyclopropylsulfonyl)-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)urea (SCAS2_05)
While the two provided compounds fall within the bounds of each of the structures of claims 1-4, they cannot be considered as representative of the whole genus of compounds being claimed, especially when the genera in question encompass such a wide variety of permutations and combinations of moieties, including compounds not sharing the bicyclic ring scaffold of the provided example compounds. Furthermore, given the limited amount of direction provided, a person of ordinary skill in the art would likely require an undue amount of experimentation to predict whether each possible compound falling within the bounds of the aforementioned claims would yield similar biological results to the exemplary compounds SCAS2_01 and SCAS2_05.
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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bellail (WO 2019/217509 A1).
Claim 1 recites a compound having the following formula:
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Bellail teaches compounds and methods of use of said compounds in the treatment of cancer. Of particular relevance to the instant claim is the following compound 52 (page 131):
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The above compound anticipates a compound of the instant claim wherein:
R1 is aryl, substituted with a single R10, wherein R10 is cyano
R2 is H
R3 is H
R4 and R5 come together to form a heterocyclic ring substituted with a single R10, wherein R10 is alkyl
Claim 2 further limits the compound of claim 1 wherein the compound is of the following formula:
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The compound of Bellail anticipates a compound of the instant claim wherein:
R1 is aryl, substituted with a single R10, wherein R10 is cyano
R2 is H
R3 is H
R10 is alkyl
R12 is H
R13 is H
Claim(s) 3 and 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goguen (US 8,716,283 B2).
Claim 3 further limits the compound of claim 1 wherein the compound is of the following formula:
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Goguen teaches compounds for use in inhibiting Type III secretion systems in pathogenic bacteria. Of particular relevance to the instant claims is the following compound 10 (Col. 87):
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The above compound anticipates a compound of the instant claim wherein:
R2 is H
R3 is H
R4 is H
R5 is H
R6 is H
R7 is H
R8 is H
R9 is H
Claim(s) 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bellail.
Claim 4 further limits the compound of claim 1 wherein the compound is of the following formula:
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The above compound anticipates a compound of the instant claim wherein:
R2 is H
R3 is H
R6 is H
R7 is cyano
R8 is H
R9 is H
R10 is alkyl
R12 is H
R13 is H
Claim(s) 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 1448071-69-9 (entered 09 Aug 2013).
Claim 5 recites a compound which is 2-(3-(5-chloro-2-methoxyphenyl)ureido)-N,N- dimethyl-6,7-dihydrothiazolo[5,4-c]pyridine-5(4H)-sulfonamide(SCAS2_01).
CAS Registry No. 1448071-69-9 is represented by the following structure:
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The above compound appears to be identical to the compound recited in the instant claim.
Claim(s) 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 1421468-43-0 (entered 20 Feb 2013).
Claim 6 recites a compound of 1-(5-chloro-2-methoxyphenyl)-3-(5- (cyclopropylsulfonyl)-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)urea (SCAS2_05).
CAS Registry No. 1421468-43-0 is represented by the following structure:
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The compound appears to be identical to the compound recited in the claim.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seguin (Journal of Biomolecular Screening 17(2) 194 –203).
Claim 7 recites the compound 6-(piperidin-1-ylsulfonyl)benzo[d)thiazol-2-amine (SCAS-02).
Seguin teaches compounds as inhibitors of SV40 large T antigen ATPase activity. Of particular relevance to the instant claim is the following compound SID 85281217 (page 199, Fig. 2):
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The compound of Seguin appears to be identical to the compound recited in the instant claim.
Claim 8 recites a pharmaceutical composition comprising a compound of claim 7 and a pharmaceutical excipient.
Seguin indicates that compounds disclosed in their study were subject to a primary activity assay, including SID 85281217 (page 200)1. Said primary activity assay was carried out in the following general protocol (page 195):
250 nL of test compound in 5% DMSO/assay buffer (100 mM Tris-HCl, 20 mM KCl, 6 mM MgCl 2 , and 0.1 mg/mL bovine serum albumin (BSA), pH 7.4) is added to assigned plate wells
750 nL of large T antigen (TAg) is added to each plate well and incubated for 30 minutes
Following incubation, 250 nL of 5 mM ATP in assay buffer was added to the respective wells and incubated for 120 min at ambient temperature.
The teachings of Seguin teach at least the use of a composition comprising test compound (i.e., SID 85281217), DMSO, and assay buffer, which meets the limitations of a composition of the instant claim.
Allowable Subject Matter
While none of the claims are currently in allowable condition, at least claim 9 may contain allowable subject matter. More specifically a method of treating sickle cell disease by administration of a compound of 6-(piperidin-1-ylsulfonyl)benzo[d)thiazol-2-amine (SCAS-02).
Conclusion
Claims 1-9 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC TRAN whose telephone number is (571)272-7854. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 “Three compounds (Fig. 2) were selected for further evaluation using targeted, mechanistic secondary assays (detailed below). These compounds (PubChem SIDs 85281215, 85281217, and 85281218) were purchased from commercial sources, purified, and retested in the primary assay for confirmation of activity.”
