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 .
Claim Status
Applicant’s remarks and amendments, filed 3 February 2026 in response to the non-final rejection mailed 3 November 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 3 February 2026 replaces all prior versions and listings of the claims.
Claims 1, 3, 5-7, 9, and 11 are pending. Claims 4 and 10 are canceled by Applicant’s amendment. Claims 1 and 6 are amended. Claims 1, 3, 5-7, 9, and 11 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s arguments and amendments, on page 11 of the reply filed 3 February 2026 with respect to the rejection of Claims 4 and 10 under 35 USC § 103 have been fully considered. The rejections of Claims 4 and 10 is withdrawn due to cancellation of the claims.
Claim Rejections - 35 USC § 103
(maintained)
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 5-7, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 10,136,663 B2) as evidenced by Geuns Jan (Archives of Food Science and Nutrition Research, 2020, 8 pages) and Shafabakhsh et al. (Pharmacological Research, 2019, 12 pages) and in view of Aditya et al. (ACS Sustain Chem Engin, 2019, 11 pages).
The instant claims are as of record, drawn to methods for preventing or treating COVID-19 or enhancing immunity comprising administering a composition comprising a curcuminoid-based compound and steviol glycoside or a licorice extract.
Lee et al. teach a method of treating an H9N2 influenza virus infection comprising administering (Lee et al., Claim 1, col. 20, line 54; as required for instant Claims 1 and 6) a compound comprising formula 1:
PNG
media_image1.png
221
646
media_image1.png
Greyscale
and stevioside (steviol glycoside; curcuminoid-based compound-containing complex; Lee et al., Claim 1, col. 20, lines 55-65; as required for instant Claims 1 and 6), wherein the stevioside is obtained from Stevia rebaudiana Bertoni (Lee et al., Claim 3, col. 21, lines 7-9; as required for instant Claims 3 and 9), wherein the composition is obtained via mixing the two compounds (Lee et al., col. 12, lines 16-20; as required for instant Claims 1 and 6). The composition can be a pharmaceutical composition (Lee et al., Abstract, page 1; as required for instant Claim 1) and administered orally (Lee et al., Claim 2, col. 21, lines 5-6; as required for instant Claims 5 and 11). The curcuminoid-based compound of formula 1 can be curcumin (Formula 2), demethoxycurcumin (Formula 3), or bisdemethoxycurcumin (Formula 4; Lee et al., Example 3, col. 13, lines 41-67 and col. 14, lines 1-40; as required for instant Claims 1 and 6).
Although Lee et al. teaches each of the active steps in the claimed method, they are
silent regarding the intended use of the method recited in the preamble i.e., preventing or treating COVID-19 or enhancing immunity wherein the immunity enhancement is an enhancement of activity or a cell number of any one or more selected from the group consisting of Th1 cells, CD8+ cells, and NK cells. Geuns Jan, however, teaches that steviol glycosides have a beneficial effect on innate immunity (enhance immunity; Geuns Jan, Immunologic Effects, page 4) and it can be used to improve general health and thus aid in prevention of COVID-19 (Geuns Jan, Conclusion and Working Hypothesis, page 6). Additionally, Shafabakhsh et al. teach that curcumin induces the formation of CD8+ cells and Th1 cells (Shafabakhsh et al., Table 3, page 7; as required for instant Claim 7), and thus this mechanism of action is inherent to the compound. The single-step method of administration is the same in both the instant and prior art methods, and thus the properties of preventing or treating COVID-19 or enhancing immunity wherein the immunity enhancement is an enhancement of activity or a cell number of any one or more selected from the group consisting of Th1 cells, CD8+ cells, and NK cells are inherent, especially in the absence of evidence to the contrary. See MPEP § 2112-2112.02.
Lee et al. do not teach wherein the curcuminoid-based compound-containing complex is water-solubilized nor its preparation via treatment with microwaves.
Aditya et al., however, teach that curcumin (curcuminoid) is poorly water soluble and that this can be solved via microwave-assisted nanonization wherein aqueous solubility and thus bioavailability is increased (Aditya et al., Abstract, page 9771; as required for instant Claims 1 and 6).
It therefore would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the application to apply microwaves as taught by Aditya et al. to the composition of Lee et al. in order to arrive at the instantly claimed application. A skilled artisan would be motivated to provide a composition comprising a mixture of all three curcuminoids in an antiviral preparation due to their excellent antiviral efficacy against H1N1 and H9N2 viruses (Lee et al., col. 17, lines 38-67 and col. 18, lines 34-34; see MPEP § 2144.06). Additionally, a skilled artisan would know that microwaves increase solubility and thus bioavailability and could therefore incorporate this method to arrive at the invention with a reasonable expectation of success.
Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP § 2113.
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Response to Arguments
Applicant's arguments filed 3 February 2026 have been fully considered but they are not persuasive.
Applicant argues that because Lee et al. do not teach the preparation of a complex comprising all three of curcumin, demethoxycurcumin, and bisdemethoxycurcumin as well as a steviol glycoside and confirm its efficacy, the prior art does not render the instant invention prima facie obvious. Lee et al., however, do disclose that all three claimed curcuminoids exhibit excellent antiviral efficacy against H1N1 and H9N2 viruses (Lee et al., col. 17, lines 38-67 and col. 18, lines 34-34). It would therefore be 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 third composition to be used for the very same purpose, thereby obtaining an antiviral preparation (see MPEP § 2144.06).
Applicant additionally argues that none of the cited references disclose or fairly teach the COVID-19 improvement or immune enhancement effects of demethoxycurcumin or bisdemethoxycurcumin individually. The claims, however, are drawn to a composition comprising all of curcumin, demethoxycurcumin, bisdemethoxycurcumin, and steviol glycoside. As taught by Lee et al., all three curcuminoids exhibit excellent antiviral efficacy against H1N1 and H9N2 viruses, and the antiviral compositions of Lee et al. comprise steviol glycoside. It would therefore be obvious to a skilled artisan to combine all three curcuminoids with steviol glycoside to arrive at an antiviral composition because of the efficacy of all three curcuminoids against H1N1 and H9N2 viruses. It is additionally noted that the data provided in the instant specification also do not indicate efficacies for individual curcuminoids.
Additionally, the evidentiary references of Geuns Jan and Shafabakhsh et al., disclose that steviol glycosides have a beneficial effect on innate immunity (enhance immunity; Geuns Jan, Immunologic Effects, page 4) and can be used to improve general health and thus aid in prevention of COVID-19 (Geuns Jan, Conclusion and Working Hypothesis, page 6). Additionally, Shafabakhsh et al. teach that curcumin induces the formation of CD8+ cells and Th1 cells (Shafabakhsh et al., Table 3, page 7; as required for instant Claim 7), and thus this mechanism of action is inherent to the compound. van de Sand et al. teach that glycyrrhizin, the primary extract from the licorice root Glycyrrhiza glabra (van de Sand et al., Introduction, page 1; as required for instant Claims 4 and 10), inhibits SARS-CoV-2 replication. The therapeutic use of preventing or treating COVID-19 is therefore inherent to the claimed composition.
Finally, Applicant argues that the claimed water-soluble complex produces results which not be obvious to a skilled artisan, however it is known in the art, as taught by Aditya et al., that food bioactives such as curcumin have poor water solubility and that this low water solubility results in low oral bioavailability, bioaccessibility, and toxicity (Aditya et al., Introduction, page 9771). Microwave-assisted nanonization, however, increases solubility, dissolution velocity, and oral bioavailability of curcumin (Aditya et al., Abstract, page 9771). A skilled artisan would therefore understand that increasing the water solubility of the claimed complex would result in increased bioavailability and therefore increase the antiviral effect of the complex.
Conclusion
No claims are allowed.
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 JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
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 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, Anand Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655