DETAILED ACTION
The preliminary amendment submitted on January 18, 2023 has been entered. Claims 11-28 are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
Claim Rejections – 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the inven-tion, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the inven-tion.
Claims 11-28 are rejected under 35 U.S.C. 112(a) as failing to comply with the enable-ment requirement. The claims contain subject matter which was not described in the specifica-tion in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention. See MPEP 2164.01(a).
The claims at issue are in the pharmaceutical arts. The independent claim is broadly drawn to a “method for the prevention and/or treatment of an infection caused by a fungus, bacterium or virus in a subject in need thereof which comprises the administration of a pharma-ceutical composition comprising a compound” of a particular formula. The dependent claims are drawn to more particular fungi, bacteria, and viruses, as well as specific chemical compounds. The independent claim, however, is drawn to the prevention or treatment of all such infections.
The following three references1 are representative of the state of the prior art as it pertains to preventing or treating an infection caused by a fungus, bacterium, or virus:
Patel P, Wermuth HR, Calhoun C, et al. Antibiotics. [Updated 2023 May 26]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https:// www.ncbi.nlm.nih.gov/books/NBK535443/
Patel P, Zito PM. Antifungal Agents. [Updated 2025 Jul 6]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm. nih.gov/books/NBK538168/
Paintsil E, Cheng YC. Antiviral Agents. Encyclopedia of Microbi-ology. 2019:176-25.
The teachings of these references and the results of the search of the prior art are discussed below.
“Various microorganisms have medical significance, including bacteria, viruses, fungi, and parasites.” See Patel & Wermuth at p. 1. While anti-bacterial agents, anti-viral agents, and anti-fungal agents are known in the prior art, they are separate and distinct therapies. “Antibiotics are compounds that target bacteria and, thus, are intended to treat and prevent bacterial infec-tions.” Patel & Wermuth at p. 1. “Antiviral agents are drugs … for the treatment or control of viral infections.” Paintsil at p. 178. “Antifungal drugs represent a pharmacologically diverse group of drugs that are crucial components in the modern medical management of mycoses,” i.e., fungal infections. Patel & Zito at p. 2. There is no evidence in the prior art that an anti-bacterial agent would be expected to be useful as an anti-viral agent or anti-fungal agent, or that an anti-viral agent would be expected to be useful as an anti-bacterial agent or fungal agent, and so forth. On the other hand, the instant claims are drawn to a method of using the very same compounds for the prevention and treatment of all fungal, bacterial, and viral infections. The prior art would lead one of ordinary skill in the art to be skeptical of the premise of applicant’s invention. Moreover, each of these types of therapies is shown in the prior art to entail a high level of unpredictability, as outlined below.
“Not all antibiotics are effective against all types of bacteria.” This statement in Patel & Wermuth at p. 4 (emphasis added) calls into question enablement of applicant’s claimed inven-tion. “If a bacterium does not contain the target for a particular antibiotic, it is known to have intrinsic resistance. … Bacteria also have the capability to gain resistance through attaining resistance genes from other bacteria or developing a mutation resulting in reduced or elimination of antibiotic efficacy. This type of resistance is known as acquired resistance.” Patel & Wermuth at p. 4. The prior art also highlights numerous problems with effective clinical use of antibiotics. “The clinical implications of antibiotic efficacy depend heavily on many factors not limited to: pharmacokinetic and pharmacodynamic principles, the particular bacteria, bacterial load, and site of infection. This is further complicated by the ability of some bacteriostatic antibiotics to exhibit bactericidal activity against particular bacteria. Therefore, bacteriostatic antibiotics also kill bacteria, but the laboratory definition makes it seem as if they do not. … This concept works in reverse, and bactericidal antimicrobials may also be bacteriostatic against certain bacterial strains and conditions.” Patel & Wermuth at p. 2. Furthermore, “[t]he location of infection is crucial to note because some antibiotics are inappropriate for treating certain infections.” Patel & Wermuth at p. 3. “In addition to the possible source(s) of infection, likely pathogens, and situation urgency, different patient factors merit consideration. Patient age, medication allergies, renal and hepatic function, past medical history, the presence of an immunocompro-mised state, and recent antibiotic usage need to be evaluated before an antibiotic selection. Many of these patient factors contribute to the pharmacodynamics and pharmacokinetics of antibiotics that will influence dosing to optimize efficacy.” Patel & Wermuth at p. 5. With these factors in mind, one of ordinary skill in the art would appreciate that there is a high level of unpredictability in the art.
The prior art recognizes similar problems with anti-fungal agents. “Fungi are eukaryotic organisms found in nearly every environment, with only a limited subset contributing to human disease. These pathogenic fungi can cause infections ranging from mild cutaneous conditions to invasive, life-threatening diseases ... Understanding the pharmacologic characteristics of anti-fungal medications—including spectrum of activity, mechanism of action, and pharmacokinet-ics—is essential for effective treatment selection.” Patel & Zito at p. 1. “While antimycotic pharmacology has advanced significantly, particularly over the last 3 decades, common invasive fungal infections still carry a high mortality rate.” Patel & Zito at p. 2. “Mechanistically, antifungal agents are diverse, yet due to the alarming and rapid increase in drug-resistant systemic fungal infections.” Patel & Zito at p. 2. This reference discloses (pp. 2-5) several different anti-fungal agents, but they are specifically indicated for the treatment of particular causative infections. None of them are described as being broadly useful in the treatment of all fungal infections, so one of skill in the art would appreciate that it is important to know which drugs are useful against which fungi. “Judicious prescribing begins with the healthcare team selecting the proper regimen based on culture and sensitivity data, patient history, and socioeconomic factors,” among other things. Patel & Zito at p. 11.
Similar issues exist with respect to antiviral drugs. “The development of antiviral agents is not trivial as viral replication is intricately linked with the host cell that any antiviral drug that interferes even to a lesser extent with host cell factors may be toxic to the host depending on the duration and dosage used. Available antiviral agents mainly target stages in the viral life cycle. The target stages in the viral life cycle are; viral attachment to host cell, uncoating, synthesis of viral mRNA, translation of mRNA, replication of viral RNA and DNA, maturation of new viral proteins, budding, release of newly synthesized virus, and free virus in body fluids. Antiviral agents used to treat viral diseases are currently limited” Paintsil at p. 178 (emphasis added).
The quantity of experimentation needed to use the invention is based on the content of the disclosure, information known in the state of the art, and the level of ordinary skill in the relevant art. It is implicit that one or ordinary skill in the art is a person who can read and under-stand these prior art references, as well as applicant’s own specification. It is the examiner’s impression that such a person would have advanced training or significant professional experi-ence in a field such as pharmacology, infectious disease medicine, or a related technical disci-pline. Even though the level of ordinary skill in the art is high, the level of predictability in the art is low, as discussed above. In light of the low level of predictability, one would look to applicant’s specification for information about how the claimed invention is used in actual clinical practice.
Applicant’s specification (pp. 73-75) includes basic information about the in vitro antibac-terial susceptibility and antibiotic activity of the claimed compounds against pathogenic bacte-rial. Also included in the specification (pp. 76-78) are the results of in vitro experiments with the compounds against various strains of fungi. It (pp. 79-80) also includes the results of one assay for assessing the activity of the compounds against human immunodeficiency virus. Nowhere, however, is there any information about how these compounds are used in the treatment of any actual infection or disease.
As explained above, in order to actually use these compounds, one would need to under-stand their pharmacokinetic and pharmacodynamic properties, the particular pathogen, and site of infection. Also as explained above, the location of the infection is crucial to understand because some drugs are inappropriate for treating certain infections. Other factors to consider include patient age, medication allergies, renal and hepatic function, past medical history, the presence of an immunocompromised state, and recent antimicrobial drug usage. None of this information is found in applicant’s specification. Furthermore, one of skill in the art would appreciate that one single compound, or a group of compounds, is unlikely to be broadly useful in the prevention or treatment of all pathogens. As such, the examiner concludes that one of ordinary skill in the art would be burdened with undue experimentation when attempting to practice the invention as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The examiner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). Exam-iner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
January 28, 2026
1 Internal citations within the quotations to these references in this Office action have been omitted to improved readability.