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
Claims 1, 9-12 and 14-24 are pending in the instant application and subject to examination herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/10/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification - Maintained
Applicant’s submission of clean and marked version of the amended Specification is acknowledged. Upon review of the amended Specifcation, the prior objection to the Specification is maintained, because of the following informalities:
Chemical structure images are faint and very difficult to interpret in the following pages: 1, 2, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, and 19. Examiner notes that these pages numbers are slightly offset from the prior set, as the text/images in the Specification are accordingly moved slightly forward in the document.
Chemical structure images contain non-standard notation, having an uninterpretable double slash, on pages 2, 7, 8, 14, 15 and 17, for example the following from page 2:
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Text does not provide any instruction on how to interpret the double slash drawing notation. A person of ordinary art would not know what this notation is intended to represent.
Applicant has traversed this objection on the ground that “in the context of chemical nomenclature and structural depiction, a double slash (//) in a chemical structure is used to represent a chain with a variable length.” Applicant’s traverse has been considered but is not found persuasive in the absence of any reasonable citation of previous use, for example a nomenclature text explaining the correct use of the symbol. Applicant’s traverse is therefore considered incomplete and inadequate.
Substituent groups are presented in various places in the Specification without any graphical indication or text instruction as to the point of attachment to the parent compound structure. Representative examples include the following:
On page 9, paragraph [0034], substituent groups are shown as chemical structures without any indication in the structures or the paragraph text to indicate the point of attachment at any of the groups.
These same structures, with the same drawing problem, are found again on page 10, paragraph [0035].
Paragraphs [0050]-[0052], [0054]-[0057] and [0059] include R group structural moieties with no indication of the point of attachment.
Applicant has traversed this objection on the ground that “a person of ordinary skill in the art would readily understand the points of attachment based on established conventions. Thus, the Specification provides sufficient detail for a person of ordinary skill in the art to understand the scope and structure of the claimed substituent groups.” Applicant’s traverse has been considered, but is not found persuasive, because a person of ordinary skill in the art would not at once envisage at what location(s) the disclosed substituents should be located in the structure. The structure of pharmaceutical compounds is understood to be inherently related to their function, said function not being assumed to operate with the arbitrary location of any the disclosed substituents at any available position on the disclosed core structures of the invention. The Specification is incomplete in providing an inventory of substituents with no information as to their location in the parent structure(s).
Appropriate correction is required.
Claim Objections - Withdrawn
The prior objection to claims 2-3 and 25-26 in regard to informalities is withdrawn in response to Applicant’s cancellation of claims 2-3 and 25-26.
Claim Objections - Maintained
The prior objection to claims 1 and 24 is maintained. The claims, as amended, continue to include, in each claim, a faint structural image that is very difficult to interpret as to what is the structure of the compound that is currently being claimed
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) - Withdrawn
The prior rejection of claims 1-3, 9-12 and 14-26 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, is withdrawn in response to Applicant’s amendment to claims 1 and 24 and cancellation of claims 2-3 and 25-26.
Claim Rejections - 35 USC § 102 - Withdrawn
The prior rejection of claims 1, 9-11, 15-16, 20-22 and 24 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ji (US PG Pub 2018/0134729 A1)1 is withdrawn in response to Applicant’s amendment of claims 1 and 24.
Claim Rejections - 35 USC § 102 – Necessitated by Amendment
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 24 is anticipated by CAS 698370-23-9.
Claim 24 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS 698370-23-9 (Chemical Abstracts Services, Registry No. 698370-23-9, originally entered on 24Jun2004 by ChemDiv, Inc)2.
Claim 24 is drawn to a composition, wherein the composition comprises the compound3 shown below:
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CAS 698370-23-9 discloses the claimed compound. Since the claim does not require that the composition comprise anything more than the compound, the claim is anticipated by the prior registry of the compound.
Thus, claim 24 is anticipated by the disclosure of CAS 698370-23-9.
Claims Free of the Prior Art
Claims 1, 9-12 and 13-23 are allowed. The following is an examiner’s statement of reasons for allowance: Prior art does not teach or reasonably suggest a method of treating or preventing cancer in a subject, the method comprising the administration of the claimed compound, 2-hydroxybenzoic acid 2-(9H-indeno[1,2-e][1,2,5]oxadiazolo[3,4-b]pyrazin-9-ylidene)hydrazide.
Closest Prior Art:
The closest prior art is found in Ji (US PG Pub 2018/0134729 A1)4 and Zhang (US PG Pub 2021/0299123 A1).
Claim 1 is drawn to a method of treating or preventing cancer in a subject, the method comprising administering to the subject a composition, wherein the composition comprises the compound 2-hydroxybenzoic acid 2-(9H-indeno[1,2-e][1,2,5]oxadiazolo[3,4-b]pyrazin-9-ylidene)hydrazide.
Ji and Zhang each disclose methods of treating cancer comprising administration of compounds disclosed therein, (Ji: paragraphs [0008] and [0230]; Zhang: paragraph [0006]), and each discloses a compound similar to the instantly claimed agent 2-hydroxybenzoic acid 2-(9H-indeno[1,2-e][1,2,5]oxadiazolo[3,4-b]pyrazin-9-ylidene)hydrazide, as shown in the table below (Ji: compound “18”5 – paragraph [0311], including Table 2, page 38, and paragraph [0336]; Zhang: compound “Formula (k)” – paragraph (0014), page 4):
Claim Number(s) of Instant Application
Instant Application
Closest Prior Art
1
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288
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Ji
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190
178
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1
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204
288
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Zhang
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308
306
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The compounds disclosed by Ji and Zhang are not within bioisosteric equivalence of the compound 2-hydroxybenzoic acid 2-(9H-indeno[1,2-e][1,2,5]oxadiazolo[3,4-b]pyrazin-9-ylidene)hydrazide that is required for the claimed method of the instant invention.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (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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/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 Cited in Applicant’s Information Disclosure Statement dated 05/18/2023.
2 Cited in Applicant’s Information Disclosure Statement dated 02/20/2026.
3 2-Hydroxybenzoic acid 2-(9H-indeno[1,2-e][1,2,5]oxadiazolo[3,4-b]pyrazin-9-ylidene)hydrazide
4 Cited in Applicant’s Information Disclosure Statement dated 05/18/2023.
5 (Z)-4-Amino-N'-(9H-indeno[l,2-b] [1,2,5]oxadiazolo[3,4-e]pyrazin-9-ylidene )-1,2,5-oxadiazole-3-carbohydrazide