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
This is a response to Applicant’s communication filed on April 8, 2026. Application No. 17/797,771, is a 371 of PCT/KR2022/005141, filed April 8, 2022, and claims foreign priority to Korean applications Nos. KOREA, REPUBLIC OF 10-2021-0046145, filed April 8, 2021; and KOREA, REPUBLIC OF 10-2021-0093159, filed July 15, 2021. In a preliminary amendment filed August 5, 2022, Applicant cancelled claims 1-14 and added new claims 15-34. In an amendment filed October 29, 2025, Applicant cancelled claims 16-18 and 24-26. Claims 15, 19-23, 27-34 are reexamined below.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 8, 2026, has been entered.
Rejection Withdrawn
The rejection of claims 15, 19-23, 27-34 under 35 U.S.C. 103 as being unpatentable over Arumugaswami et al., US2023/0190736 A1, in view of Jeong et al., WO2018/131890 A1, is withdrawn in view Applicant’s April 8, 2026, Amendment & Remarks.
New Rejections
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 15 and 19-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. In this case, claims 15 and 19-22 are drawn to a composition comprising rottlerin (mallotoxin) which is a polyphenol natural product isolated from the Asian tree Mallotus philippensis. See Lu et al., Determination of Rottlerin, a Natural Protein Kinases C Inhibitor, in Pancreatic Cancer Cells and Mouse Xenografts by RP-HPLC Method, 4(1) J. Chromatogr Sep Tech. 1-13, Abstract (January 1, 2013).
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.”
See MPEP 2111.02 II.
In this case, the body of the claim fully and intrinsically sets forth all of the limitations of the claimed invention, i.e., a composition comprising rottlerin.
Rottlerin does not fall within at least one of the four categories of patent eligible subject matter of a process, machine, manufacture, or composition of matter. A “new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter” under Section 101. See Chakrabarty, 447 U.S. at 309, 206 USPQ at 197. Although rottlerin can be isolated from Mallotus philippensis, this does not, by itself, render rottlerin patent eligible. In this case, there is no indication that the isolated rottlerin has any characteristics (structural, functional, or otherwise) that are different from its non-isolated form. Because there is no difference between the claimed compound and the naturally occurring compound, the claimed compound does not have markedly different characteristics from what occurs in nature, and thus is a “product of nature” exception. According the claim is directed to an exception. Although, the claim includes rottlerin in a liposome encapsulated microparticle this additional feature does not add significantly more to the exception. Therefore, the claims does not qualify as eligible subject matter, and are reject accordingly.
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 23 and 27-34 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al., Determination of Rottlerin, a Natural Protein Kinases C Inhibitor, in Pancreatic Cancer Cells and Mouse Xenografts by RP-HPLC Method, 4(1) J. Chromatogr Sep Tech. 1-13 (January 1, 2013), in view of Arumugaswami et al., US2023/0190736 A1, Munin & Edwards-Levy, Encapsulation of Natural Polyphenolic Compounds; a Review. 3 Pharmaceutics 793-829 (2011); and Maioli et al., Rottlerin and curcumin: a comparative analysis, Ann. N.Y. Acad. Sci. 1259, 65-76 (2012). Lu teaches that Rottlerin (Mallotoxin) is a natural polyphenolic ketone isolated from the pericarps of Mallotus phillippinensis. Lu et al., p. 2, Introduction. Rottlerin is most well-known as an inhibitor of protein kinases C (PKC) with selectivity for PKC δ. Id. It is also a mitochondrial uncoupler that depolarizes the mitochondria membrane potential, reduces cellular ATP levels and activates 5’-AMP activated protein kinase (AMPK) and affects the mitochondrial production of reactive oxygen species. Id. Moreover, rottlerin can target many key regulatory kinases including p38 regulated /activated kinase, cAMP dependent protein kinase, casein kinase II, glycogen synthase, kinase 3-beta, AKT/PKB, and calmodulin-dependent kinases. Id. The difference between the prior art and present invention is the use of the known polyphenol, rottlerin to treat a viral infections and it Is administration as a liposome encapsulated microparticle.
Arumugaswami teaches that known PCK inhibitors, such as rottlerin are useful in the treatment of viral infections. See Arumugaswami et al., ‘US ‘736 Publc’n, p.1, para. [0005]; see Id., specifically, p. 2-3,. paras. [0027]-[0029] for the use of the PKC inhibitor, rottlerin to treat viral infections.
With the respect, to the administration of rottlerin as a liposome encapsulated microparticle, it was well known at the time of the invention to encapsulate natural polyphenolic compounds, such as rottlerin. See Munin & Edwards-Levy, Abstract; see also Id., Section 3.4.2. Liposomes; also see Id., Table. 3. Although, Munin & Edwards-Levy does not specifically exemplify rottlerin as a polyphenol encapsulated as a microparticle liposome, the chemical structures and properties of rottlerin are similar to that of the polyphenol curcumin which is exemplified. See Id., Table 3; see also Maioli et al., Abstract. Accordingly, all the elements of the present invention were known in the art at the time of the invention.
It would have been obvious to the ordinary artisan at the time of the invention to use rottlerin to treat a viral infection as presently claimed and to optimize the delivery of rottlerin as an encapsulated liposome microparticle as taught by the prior art with a reasonable expectation of success. All the elements of the present invention were known in the art at the time of the invention. The present invention uses known techniques to improve upon a known method in the same way to yield predictable results.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625
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