DETAILED ACTION
The amendment submitted on September 9, 2025 has been entered. Claims 15-16 and 18-31 are pending in the application. Claims 15-16 are withdrawn. Claims 18-31 are rejected for the reasons set forth below. No claim is allowed.
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 . 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.
Election/Restrictions
Applicant’s election with traverse of Group III, drawn to a method of preventing or treat-ing Mycobacterium infection, in the reply filed on September 9, 2025 is acknowledged. No particular arguments are presented in traversal, so the requirement is still deemed proper and is therefore made FINAL. Claims 15-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on September 9, 2025. As discussed in MPEP 821.04 (rejoinder), claims 15-16 will not be eligible for rejoinder. The examiner therefore suggests that with withdrawn claims be cancelled or the requirement be petitioned. See 37 C.F.R. 1.144 (petition from requirement for restriction). Claims 18-31 correspond to Group III, i.e., the elected invention, and are under consideration.
Claim Rejections – 35 USC § 102
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 18 and 20-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Final Report on the Mass Production of Marine Microorganisms Originating Physiological Active Natural Products and the Development of New Drug Materials Using Biotechnology Methods,” released February 10, 2020 and published July 20, 2020.
This “Final Report” was cited in applicant’s information disclosure statement submitted on August 12, 2022. Substantial portions of it are in Korean, so the examiner obtained an English-language translation of relevant portions from the Scientific & Technical Information Center (STIC) of the USPTO. The translation is 17 pages in length, and a copy of it is included with this action. The following discussion refers to the translation instead of the original Korean-language document.
The Final Report discloses (see, e.g., pp. 5-6) that Arenicolide A and Arenicolide C are both active against Bacillus Calmette-Guerin (BCG) in a mouse model for tuberculosis treatment. Arenicolide A is the compound of Formula 4 recited in claim 26, and it is within the scope of claims 20-25. Arenicolide C is the compound of Formula 5 recited in claim 26 and is also within the scope of claims 20-25. See applicant’s specification at p. 21 for the chemical structures of Arenicolide A and Arenicolide C. Applicant’s specification (p. 22) also explains that BCG is a strain of Mycobacterium bovis, so the examiner concludes that the disclosure of BCG in the reference meets the limitations of claim 29.
Claim Rejections – 35 USC § 103
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 18-20 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over the Final Report as applied above.
The Final Report is relied upon as set forth above. The difference between the prior art and the claims at issue is that this reference does not specifically disclose co-administering an antibiotic, such as isoniazid (see instant claim 31). The Final Report, however, recognizes that isoniazid is “a standard treatment for tuberculosis” (p. 12). As a matter of law, it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a combination to be used for the very same purpose. The idea of combining them “flows logically from their having been individually taught in the prior art.” See MPEP 2144.06(I) (combining equivalents known for the same purpose). The Final Report separately teaches or suggests using Arenicolide A and Arenicolide C for treating tuber-culosis, as well as using isoniazid for treating the very same disease. Their combined use within the meaning of claims 19 and 30-31 is therefore prima facie obvious.
Claim Rejections – 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a) and 112(b):
(a) IN GENERAL.—The specification shall contain a written description of the invention, 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 invention.
(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.
Claims 18-31 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for “treating,” does not reasonably provide enablement for “preventing.” The speci-fication does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. In addition, or in the alternative, claims 18-31 are rejected under 35 U.S.C. 112(b) 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.
Applicant appears to be using the word “preventing” in a manner that is inconsistent with its established meaning in this technology area. According to the “WHO consolidated guidelines on tuberculosis: Tuberculosis preventive treatment” (2020), tuberculosis (TB) preventive treat-ment “is only given to people who are infected with TB bacteria or have been exposed to it and are at a higher risk of developing TB disease than the general population.” On the other hand, applicant’s specification states that “[t]he term ‘prevention’ refers to any action that suppresses a disease or delays the onset of a disease by administration of a composition.” See specification at pp. 10-11. This would appear to include people other than those identified in the WHO guide-lines. It is for this reason that the claims are rejected under § 112(b) as being indefinite.
With respect to enablement, the claims appear to read on treating persons that have no exposure to TB and are otherwise healthy. The search of the prior art shows that this is not an established utility for tuberculosis medications. The state of the prior art with respect to “prevention” of tuberculosis is well summarized in Vasiliu et al., Clin. Microbiol. Infect. 2024;30(9):1123-30. According to Vasilu (see, e.g., Fig. 1 at p. 1124 and the discussion thereof) vaccination is known as an effective means for preventing infection. Treatment with medication, however, is only acknowledged in the prior art for preventing “progression to disease,” not prevention of infection itself. The instant claims, which are clearly not drawn to a vaccine, appear to be directed to the prevention of infection, which is contrary to established medical norms. In light of this, one of skill in the art would look to applicant’s specification for information about how TB could be prevented. There are no working examples in applicant’s specification, and applicant posits no scientific rationale for why prevention would be effective, so the examiner concludes that one of skill in the art would be burdened with under 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 exam-iner can normally be reached Monday - Thursday, 7:00 am - 6:00 pm (Eastern Time).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encour-aged 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 supervi-sor, 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
December 3, 2025 (revised January 9, 2026)