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 .
Detailed Action
Claims 1-12 are currently pending.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code: “https://doi.org/10.3390/ijms232314611” on Page 21. 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.
Appropriate correction is required.
Claim Objections
Claims 1, 5-8, and 12 are objected to because of the following informalities:
Claim 1: one of the commas deleted in the definition of R1 should be readded to denote separation between the alkoxy radical group and the nitro group.
Claim 1: variables i, j, and k should be subscripts within their respective structural formulae (e.g.: “-(Y)j-Z” instead of “-(Y)j-Z”).
Claim 5: “where” should be changed to “wherein”.
Claims 6-8: the structures depicted in each of the claims should be replaced with a darker sharper image clearly depicting each respective structure and groups.
Claim 7: some groups are referred to as “OMe” and “SMe” despite the same groups instead being called “OCH3” and “SCH3” in Claim 1, for example. The names of the same respective groups should be standardized.
Claim 8 should instead read “of the formula below”.
Claim 12 should instead read “as an active principle”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-12 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 regards as the invention.
Claim 1 recites “the stereoisomeric forms, the mixtures of stereoisomeric forms, or the pharmaceutically acceptable salts thereof”. This limitation using “the” lacks antecedent basis because no stereoisomer, mixture, or salt is previously set forth. It is unclear which forms “the” specifically refers to—if any. Claims 2-12 are rejected by virtue of dependency.
Claim 9 recites “the cells”. However, no cells are previously mentioned or described. Therefore, “the cells” lacks antecedent basis and it is unclears what “cells” “the” refers to. Claims 10-11 are rejected by virtue of dependency.
Claim 10 recites “the Shiga-like toxins” and “the pertussis toxin”. Again, “the” lacks antecedent basis because no Shiga-like or pertussis toxin(s) are previously described.
Closest Prior Art
The closest prior art is disclosed in Cintrat (WO2020109510; 10/04/2024 IDS). Cintrat teaches “a new family of compounds of the type 2,3-dihydroquinazolin-4(lH)-one and the use thereof as inhibitors of the toxic effects of intracellular-acting toxins…using retrograde transport to intoxicate the cells, or viruses or bacteria using retrograde and/or syntaxin 5-dependent transport to infect the cells, specifically viruses or bacteria entering into the cells by means of endocytosis, or intracellular parasites” (Abstract). Exemplary compounds include Compound 7 on Page 6:
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. Compound 7 differs from that of examined Claim 8,
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, only in that the m-OH is instead o-substituted. One of skill in the art seeking to form a homolog for the same purpose might find varying the single substituent position prima facie obvious. However, applicant discloses surprising and unexpected results so as to distinguish the closest embodiment of Cintrat from those of the examined genus of compounds. First, “this new family of molecules exhibits a biological activity which is as effective as or even superior to that of compounds from the family of molecules” (Page 4). Second, “a better bioavailability relative to the molecules known in the art” is demonstrated (Page 4). Regarding superior activity, examined Compound 1 of Claim 8 has significantly superior EC50 values compared to the compounds of the prior art with respect to syntaxin activity and against specific viruses shown in Table 3, including Compound 7 of Cintrat or Compound E as it is called in the instant specification:
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.
Regarding bioavailability, Figs. 1-2 demonstrate significant superior bioavailability of Compound 1 as compared to E during at least the 1hr time point following administration with an oral gavage and subcutaneously. Such properties are surprising as the closest art in Cintrat does not teach potentially superior properties of the instant compounds—let alone permit the heteroatom substitution scheme as described in Claim 1 to achieve these superior compounds. Rather, Cintrat restricts substitution to a single o-substituent:
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(page 3). Therefore, no rejection over Cintrat, the closest prior art, is applied.
Conclusion
No claim is allowable.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney 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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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
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