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 .
Claims 1-16, 20, 21, 31, and 32 are pending in the instant application. Claims 7, 20, 21, 31, and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected subject matter. The withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference which anticipates one group would not render obvious the other. Claims 1-6 and 8-16 are rejected.
Information Disclosure Statement
The information disclosure statement filed on January 16, 2026 has been considered and a signed copy of form 1449 is enclosed herewith.
Election/Restrictions
Applicant’s election with traverse of Group I, claims 1-16, and the species of anti-malarial agents: OZ439 and OZ277, in the response filed on May 1, 2026 is acknowledged. The traversals are that 1. Group I and Group II claims share the same technical features and 2. that OZ277 and OZ439 have unity of invention under PCT Rule 13.1 and 13.2, and do not present any undue search burden on the Office. The traversal between groups is not found to be persuasive because the inventions are independent and distinct because there is no patentable co-action between the groups and a reference anticipating one member will not render another obvious. Each group is directed to art recognized divergent subject matter which require different searching strategies for each group. Moreover, the examiner must perform a commercial database search on the subject matter of each group in addition to a paper search, which is quite burdensome to the examiner. Therefore, the restriction requirement between groups is maintained and hereby made final. The traversal of the species restriction between OZ277 and OZ439 is found to be persuasive. However, the species restriction between (OZ277 and OZ439) and the remaining anti-malarial agents is maintained and is hereby made final.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-6 and 8-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2020/0138775 A1.
US 2020/0138775 A1 discloses methods of treating or preventing a virus in a subject comprising administering ozonides, such as OZ439 and OZ277 (see abstract, Fig. 1 and Table 1). It is disclosed that pharmaceutical compositions of the invention comprise an effective amount of one or more of the ozonides dissolved or dispersed in a pharmaceutically acceptable carrier (see [0057]). Therefore, a composition of the instant claims comprising a therapeutically effective dose of at least one anti-malarial agent, wherein the at least one anti-malarial agent comprises a trioxolane (secondary ozonide), OZ277 and OZ439, and a pharmaceutically acceptable carrier is anticipated by the reference.
With respect to the art rejection above over the claims, it is noted that the reference does not teach that the compositions can be used in the manner instantly claimed (i.e., for treating a non-tuberculous mycobacterial infection in a subject or that the composition treats and/or prevents at least one symptom of the non-tuberculous mycobacterial infection in the subject). However, the intended use of the claimed compositions does not patentably distinguish the compositions, per se, since such disclosed use is inherent in the reference compositions. In order to be limiting, the intended use must create a structural difference between the claimed compositions and the prior art compositions. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Also, with respect to claims 9, 11 and 13, it is noted that the specification or claims do not clearly define the phrase “consists essentially of.” Therefore, the examiner has treated the phrase as equivalent to “comprising” for prior art search and application purposes.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6 and 8-16 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0138775 A1.
US 2020/0138775 A1 discloses methods of treating or preventing a virus in a subject comprising administering ozonides, such as OZ439 and OZ277 (see abstract, Fig. 1 and Table 1). It is disclosed that pharmaceutical compositions of the invention comprise an effective amount of one or more of the ozonides dissolved or dispersed in a pharmaceutically acceptable carrier (see [0057]). It is also disclosed that the actual dosage amount of a composition of the invention administered to an animal patient can be determined by physical and physiological factors such as body weight, severity of condition, the type of disease being treated, previous or concurrent therapeutic interventions, idiopathy of the patient and one the route of administration (see [0065]).
The reference does not disclose pharmaceutical compositions wherein at least one anti-malarial agent, or specifically OZ277 or OZ439, is present in a composition in an amount ranging from about 5 mg to about 1200 mg.
However, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to arrive at the compositions of the instant claims in view of the reference with a reasonable expectation of success. The motivation would have been to make optimal pharmaceutical compositions which can be used for the quoted purpose. Thus, a prima facie case of obviousness has been established.
With respect to the art rejection above over the claims, it is noted that the reference does not teach that the compositions can be used in the manner instantly claimed (i.e., for treating a non-tuberculous mycobacterial infection in a subject or that the composition treats and/or prevents at least one symptom of the non-tuberculous mycobacterial infection in the subject). However, the intended use of the claimed compositions does not patentably distinguish the compositions, per se, since such disclosed use is inherent in the reference compositions. In order to be limiting, the intended use must create a structural difference between the claimed compositions and the prior art compositions. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Also, with respect to claims 9, 11 and 13, it is noted that the specification or claims do not clearly define the phrase “consists essentially of.” Therefore, the examiner has treated the phrase it as equivalent to “comprising” for prior art search and application purposes.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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