DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Claims 1 and 28 – 56 are pending.
Claims 36 – 38 and 40 are rejected.
Claims 1, 28 – 35, 39 and 41 – 56 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 29 – 56, in the reply filed on November 14, 2025 is acknowledged. Applicant further specifically elected the compound 2-(3-cyano-4-phenoxyphenyl)-7-hydroxythiazolo[5,4-d]pyrimidine in claim 56. The compound is presented below:
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.
The compound reads on the structure of General Formula (I):
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426
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, wherein:
R1 represents an unsubstituted phenyl group,
R2 represents a cyano group,
R3 represents a hydrogen atom,
X represents an oxygen atom, and
Y represents a sulfur atom.
Applicant further elected a method for treatment or prevention of retinitis pigmentosa as the single method of use of the pharmaceutical composition comprising the compound represented by General Formula (I).
Examination: Claims 36 – 38 and 40 read on the elected species. The elected species of the compound and the method are no allowable. Examination of the Markush-type claim has not been extended to include the scope of non-elected species. Claims 1, 28 – 35, 39 and 41 – 56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/ species, there being no allowable generic or linking claim.
Priority
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382
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Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on June 6, 2023, October 9, 2024 and April 28, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 36 is objected to because of the following informalities:
Claim 36 is directed a method for treatment or prevention of an ATP-related eye disease, comprising an effective amount of the pharmaceutical composition according to claim 1 to a subject in need thereof. Claim 36 is directed to a different group of invention compared to the invention of claim 1. Applicant is requested to recite claim 36 in independent form and incorporate all limitations of the pharmaceutical composition comprising the compound represented by General Formula (I).
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.
Claim 38 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.
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 38 recites the broad recitations: a retinal degenerative disease (page 4, line 7 of the claim), demyelinating optic neuropathy disease (page 5, line 6), and toxic optic neuropathy (page 5, line 6). The claim also recites the limitations: “including a drug-induced (including chloroquine) retinal disorder” (page 4, lines 7-8 of the claim), “(including multiple sclerosis)” (page 5, line 6), and “(including ethambutol, methanol, and thinner)” (page 5, lines 6-7), which is the narrower statements of the range/limitation. The claim is 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.
In order to overcome the rejection, Applicant may amend to delete all of the narrower limitations in the 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.
(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.
Claims 38 – 40 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Yoshida et al. WO 2019/208635 A1 (publ. October 31, 2019; effect. filed April 27, 2018), as cited in IDS dated June 6, 2023, evidenced by English translation of WO 2019/208635 A1, Retrieved on January 23, 2026.
Yoshida et al. teach compound 6. See, Table 1, page 17. Compound 6 is presented below:
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Yoshida et al. also teach pharmaceutical compositions comprising said compound, a tautomer, a stereoisomer, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier. See attached English translation, e.g., paragraph [0009], page 9, lines 4-12. The pharmaceutical composition can be formulated for parenteral administration or oral administration in solid or liquid form to humans. See, e.g., paragraph [0030], page 21. The compound exhibits high xanthine oxidase inhibitory activity and excellent metabolic stability. See, e.g., paragraph [0006], page 5. Yoshida further teaches methods for using the composition for the treatment and prevention of chronic kidney diseases. See., e.g., paragraph [0010].
The prior art anticipates the instant claims as presented below:
With respect to Claims 36 – 38, the limitation “for treatment or prevention of an ATP-related eye disease” is an intended use limitation as governed by MPEP §2111.02(II). Intended use limitations are interpreted based on the structural limitations they impart to the invention. In this case, the intended use only requires the method comprising administering an effective amount of the pharmaceutical composition comprising the compound represented by General Formula (I) for treatment or prevention of an ATP-related eye disease, specifically retinitis pigmentosa, but does not impart any specific limitations to the structure. Based on the teachings of Yoshida et al, an effective amount of the pharmaceutical composition comprising compound 6 is capable of being administered in the method for treatment of prevention of retinitis pigmentosa to a subject in need thereof. Compound 6 in Yoshida reads on the structure of General Formula (I):
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182
426
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, wherein:
R1 represents an unsubstituted phenyl group,
R2 represents a cyano group,
R3 represents a hydrogen atom,
X represents an oxygen atom, and
Y represents a sulfur atom.
With respect to Claim 40, Yoshida et al. also teach the dosage of the pharmaceutical composition comprising the compound for adults is 0.1 μg to 10 g/day, preferably 0.001 to 2000 mg/day, when administered orally and can be adjusted depending on age and symptoms. See, e.g., paragraph [0036]. The disclosed range encompasses the claimed range of 10 to 320 mg per day. Yoshida also teaches in vitro inhibitory activity (IC50) of compound 6 against bovine milk-derived xanthine oxidase. See, e.g., paragraph [0052], Table 2. The activity is presented below:
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“… [t]he test compound was dissolved in dimethyl sulfoxide and then diluted with 50 mmol/L phosphate buffer (pH 7.5) to prepare a solution of the specified concentration… 125 μL of test compound solutions prepared at various concentrations was added to 1 mL of 250 μmol/L Xanthine (Sigma-Aldrich) solution prepared in 50 mmol/L phosphate buffer (pH 7.5), and the mixture was pre-incubated at 30 °C for 5 minutes”. See, paragraph [0052], Test Example 1. Thus, the pharmaceutical composition comprising compound 6 exhibits high xanthine oxidase inhibitory activity and excellent metabolic stability and capable of being administered in the method for treatment of prevention of retinitis pigmentosa to a subject in need thereof.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST.
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/Sagar Patel/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626