The action mailed 12/5/2025 is hereby withdrawn in favor of the instant action. This is done to properly address pending claim 27 that was not previously addressed in the action mailed 12/5/2025.
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
The Amendments filed on July 7, 2025 has been received and entered.
Currently, Claims 10-11, 15-16, 18, 23, and 26-27 are pending and examined on the merits.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
Applicant’s election of the species in the reply filed on June 16, 2023 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/1/22 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Claim Rejections - 35 USC § 103
Claim(s) 10-11, 15-16, 18, 23, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (2016, PLOS Pathogens, 12(7): e1005685) in view of Hammarstrom et al. (US 20130323819 A1). This is not a new rejection.
Wang et al. teaches a method of using Purpureocillium lilacinum for antimalarial treatment (Author Summary). P. lilacinum was extracted in EtOAc, then eluted with MeOH-H2O (from 40-100%) (page 21, Culture extraction and HPLC-MS profiling). EtOAc and MeOH are organic solvents. The same solvent would inherently contain the fungal metabolite having the structure of Claim 6, specifically puxilin, which is a bioactive . The same extract when used for treating malaria would have the same mechanism of Claim 26. Malaria infects the blood. A method of treating malaria would involve treating the blood. Malarial drugs are administered orally for delivery to the blood. The method of inhibiting malaria transmission via contacting the infected blood with Purpureocillium lilacinum extract would inherently occur for the resulting treatment to occur.
However, Wang et al. does not teach spraying.
Hammarstrom et al. teaches a method treating malaria [0148] with Penicillium thomii as a delivery vehicle [0036], where the methods and compositions described herein relate to delivering a delivery vehicle to a target area. In one embodiment, a delivery vehicle is a microorganism. In one embodiment, a microorganism is delivered to a target area by directly applying the delivery vehicle to the target area. Methods of delivery include, but are not limited to, ingestion, inhalation, injection, sprays, and topical application [0039]. The treatment of malaria would require a subject infected with malaria.
The reference also does not specifically teach formulating the composition in the forms claimed by applicant. Hammarstrom et al. teaches a method treating malaria [0148] with Penicillium thomii as a delivery vehicle [0036], where the methods and compositions described herein relate to delivering a delivery vehicle to a target area. In one embodiment, a delivery vehicle is a microorganism. In one embodiment, a microorganism is delivered to a target area by directly applying the delivery vehicle to the target area. Methods of delivery include, but are not limited to, ingestion, inhalation, injection, sprays, and topical application [0039]. These pharmaceutical forms are well known in the art to be acceptable means of administering a pharmaceutically active substance. Based on this knowledge, a person of ordinary skill in the art would have had a reasonable expectation that formulating the composition taught by the references in the claimed forms would be successful. Therefore, an artisan of ordinary skill would have been motivated to formulating the composition taught by the reference in the forms claimed by applicant.
Response to Arguments
Applicant argues that Wang et al. does not teach spraying.
In response to Applicant’s argument, Hammarstrom et al. teaches a method treating malaria [0148] with Penicillium thomii as a delivery vehicle [0036], where the methods and compositions described herein relate to delivering a delivery vehicle to a target area. methods and compositions described herein relate to delivering a delivery vehicle to a target area. In one embodiment, a delivery vehicle is a microorganism. In one embodiment, a microorganism is delivered to a target area by directly applying the delivery vehicle to the target area. Methods of delivery include, but are not limited to, ingestion, inhalation, injection, sprays, and topical application. In one embodiment, a microorganism is delivered in a pharmaceutical composition, such as a foam, cream, patch, gel, powder, solution, liquid, oil, oral solution, vaginal wash, vaginal douche, breast milk supplement, infant formula or petroleum jelly. In another embodiment, a microorganism is delivered in a pharmaceutical composition formulated as a suppository, as an aerosol, as a liquid, as a tampon, or as a tablet. Routes of administration include, but are not limited to, intranasal, rectal, vaginal, intraperitoneal, intravascular, hypodermic, oral, intraurethral, intraocular, inhalation, or other routes known in the art as medically safe route of administration [0039]. Thus, using a spray is a known method of delivering a chemical for treating a condition and motivation to combine the references.
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 CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached Monday-Friday 9-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached at 571-272-0775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Catheryne Chen Examiner Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655
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