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 .
CONTINUING DATA
This application is a 371 of PCT/CN2022/119159 09/15/2022
FOREIGN APPLICATIONS
CHINA 202111082439.X 09/15/2021
CHINA 202111466166.9 12/03/2021
Claims 1, 3-4, 6-7, 14, 17, 19, 21, 25, 29-30, 33-34, 37, 46, 49-50 are pending.
Drawings
The drawings are objected to because the legend for Figure 2 is incomplete. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 3-4, 6-7, 14, 17, 19, 33, 37 46, and 49-50 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.
Claims 1 and 19 recite “at least one atovaquone.” Atovaquone is a single defined compound as shown in paragraph [00170] of the current specification. It is unclear which other compounds might be included in “at least one” atovaquone. The examiner did not find a definition or guidance in the specification for which other compounds are encompassed by atovaquone. Claims 3-4, 6-7 depend from claim 1 and incorporate the same limitation by reference. Claims 33, 37, 46, and 49-50 depend from claim 19 and incorporate the same limitation by reference.
Claim 4 recites a method of using the drug of claim 1 for treating or preventing coronavirus infection or diseases or conditions associated thereof. Claim 4 is unclear because it does not recite any steps involved in the method. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how the method is actually practiced. Claims 6-7, 14 depend from claim 4 and incorporates the same limitation by reference.
The terms “common,” “severe,” and “critically” in claim 46 are relative terms which are not defined by the claim or the specification. The specification does not provide a standard for ascertaining the requisite degree.
Claim 17 depends from claim 8, which is canceled. Claim 17 will be treated as though it depends from claim 4.
Claim 17 recites that nitazoxanide, atovaquone and ribavirin can be administered once daily, etc. It is unclear whether the agents must be administered once daily, etc., or whether that is optional.
Conclusion
Claims 1, 3-4, 6-7, 14, 17, 19, 33, 37 46, and 49-50 are rejected. Claims 21, 25, 29-30, 34 are objected to as depending from a rejected base claim.
The closest prior art is Cho (WO 2020/214716 A1, cited on IDS). Cho teaches that nitazoxanide, ribavirin, and atovaquone can be used for treating coronavirus infections. See paragraphs [0002] and [0181]-[0191]. Cho teaches these three agents as additional agents which can be used along with compounds in paragraph [0005]. The three agents are among a very long list of compounds which can be used along with compounds in paragraph [0005], and they are mentioned in separate categories. Table 1 in the current specification shows that the combination of NTZ and ATQ and the combination of NTZ and ATQ and RBV show a synergistic effect in terms of anti-SARS-CoV-2 virus activities. Data for TIZ is not shown in Table 1, but the structure of TIZ is very similar to the structure of NTZ as shown on pages 34-35 of the specification, so the skilled artisan would reasonably expect similar activity.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693
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