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 office action is in response to applicant’s reply filed on October 29, 2025.
Restrictions/Elections.
Applicant’s election of Group I (Claims 41-51) in the reply filed on October 29, 2025is 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).
Applicant election of the following species:
Flavonoids - taxifolin, quercetin and EGCG
zinc compound - zinc picolinate
copper compound - copper sulfate
PPAR agonist (present) - naringenin
Is also acknowledged.
Status of Claims
Claims 41-59 are currently pending and are the subject of this office action.
Claims 52-59 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 29, 2025.
Claim 47 is further withdrawn since it is not encompassed by the elected species.
Claims 41-46 and 48-51 are under examination.
Priority
PNG
media_image1.png
64
376
media_image1.png
Greyscale
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 41-46 and 48-51 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) a composition comprising:
(a) at least two flavonoid zinc ionophores selected from the group consisting of: taxifolin, quercetin and epigallocatechin gallate (EGCG);
(b) at least one zinc compound; and
(c) at least one copper compound,
optionally further comprising at least one phenol peroxisome proliferator-activated receptor (PPAR) agonist.
This judicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The rationale for this determination is explained below:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
The elected subject matter, within the scope of the instant claims is construed as a composition comprising:
(a) at least two flavonoid zinc ionophores selected from the group consisting of: taxifolin, quercetin and epigallocatechin gallate (EGCG),
(b) at least one zinc compound; and
(c) at least one copper compound,
So, the answer to Step 1 is: Yes, the claims are drawn to a composition of matter.
Step 2A Prong One: Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea?
The claimed subject matter appears to describe the mixture of at least 3 natural products:
(a) at least two flavonoid zinc ionophores selected from the group consisting of: taxifolin, quercetin and epigallocatechin gallate (EGCG);
(b) at least one zinc compound; and
(c) at least one copper compound,
Because each compound is naturally occurring, so their combination together in a composition is considered a “product of nature,” which falls within each of the categories: “laws of nature” and “natural phenomena”. Thus, the claims are drawn to judicially recognized exceptions. See p74623, left column, of the Federal Registry notice: …Courts have held that naturally occurring products and some man-made products that are essentially no different from a naturally occurring product are ‘‘products of nature’’ that fall under the laws of nature or natural phenomena exception. (Section I (3); pp. 74622-4 of the Federal Registry notice discusses Natural Products.).
The next question within step 2A Prong One is: does the nature-based product show “markedly different characteristics” from any naturally occurring counterpart(s) in their natural state, based on structure, function and/or properties?
Claims 41-46 and 48-51 recite a composition comprising natural products in a single formulation. Relative to this composition, there is no naturally occurring counterpart to the claimed composition having all these compounds present in the same combination. In this case, the combination is compared to the mixture of components as they occur in their natural state. See p. 74623 of the Federal registry notice, middle column:
“The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. When there is no naturally occurring counterpart to the nature-based product, the comparison should be made to the closest naturally occurring counterpart. In the case of a nature-based combination, the closest counterpart may be the individual nature-based components that form the combination, i.e., the characteristics of the claimed nature-based combination are compared to the characteristics of the components in their natural state”.
Establishment of a marked difference cannot be based on some inherent or innate characteristic of the naturally occurring counterpart. See p. 74623, footnote 28:
“To show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (‘‘[The inventor did] not create a state of inhibition or of non-inhibition in the bacteria. Their qualities are the work of nature. Those qualities are of course not patentable.’’); In re Marden, 47 F.2d 958 (CCPA 1931) (eligibility of a claim to ductile vanadium held ineligible, because the ‘‘ductility or malleability of vanadium is . . . one of its inherent characteristics and not a characteristic given to it by virtue of a new combination with other materials or which characteristic is brought about by some chemical reaction or agency which changes its inherent characteristics’’). Further, a difference in a characteristic that came about or was produced independently of any effort or influence by applicant cannot show a marked difference. Roslin, 750 F.3d at 1338 (Because ‘‘any phenotypic differences came about or were produced ‘quite independently of any effort of the patentee’’ and were ‘‘uninfluenced by Roslin’s efforts’’, they ‘‘do not confer eligibility on their claimed subject matter’’ (quoting Funk Bros.)).
In the instant case, there seems to be no indication in the specification that the combination of all of the above natural products has any characteristics (structural, functional or other properties) that are different from the naturally occurring compounds in nature.
Thus, the composition does not have markedly different characteristics from what occurs in nature and is a “product of nature exception”.
So, the answer to Step 2A Prong One is: Yes, the claims are drawn to a natural composition.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
The only additional element that the claims recite, besides the natural components is “a physiologically acceptable medium”.
So, the answer to Step 2A Prong Two is: No, the claims do not recite additional elements that integrate the judicial exception into a practical application
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exemption?
The claims require “a dietary supplement” or “a pharmaceutical composition” both of which can encompass natural products.
So, the additional elements (“a dietary supplement” or “a pharmaceutical composition”) include natural products. So, the composition still encompasses mixtures of natural products.
Because the claim does not include any additional features that could add “significant more” to the exception the answer to Step B is: No, the claims do not recite additional elements that amount significantly more than the judicial exception.
The claims do not qualify as eligible subject matter and are properly rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 103
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.
1) Claim(s) 41, 44-45, 48 and 50-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brady (Functional Medicine blog retrieved from the internet: https://viorlife.com/the-natural-alternative-to-hydroxychloroquine/ (March 21, 2020) cited by Applicant) and Park (retrieved from https://medium.com@jayparkmd/covid-19-alternative-treatments-3b204d3155df (July 21, 2020), cited by Applicant) in view of Berg et. al (WO 2002/09699 February 7, 2002, cited by Applicant) and Trofimova et. al. (Russian Chemical Bulletin (2015) 64:1430-1436, cited by Applicant).
For claims 41, 44-45 and 48, Brady teaches a method of treating COVID-19 comprising administering to a patient in need thereof a composition comprising quercetin, Epigallocatechin-gallate (EGCG) and Zinc as a gluconic acid salt or zinc glycinate or zinc picolinate. EGCG amplifies the effectiveness of quercetin as zinc ionophore. This suggests that ECGC and quercetin provide synergistic effect with enhanced bioavailability (see pages 4-6). Ionophores like quercetin and ECGC move zinc in and out of the cell. Zinc is known to inhibit RNA polymerase. It essentially limits the ability of the virus to replicate itself and overwhelming the cell (see page 3 under Zn ionophore).
Park, like Brady teaches a method of treating COVID-19 comprising the administration of quercetin, EGCG and zinc supplements (see entire reference).
None of the above references teaches the treatment of COVID-19 comprising the administration of taxifolin (Dihydroquercetin or DHQ). However, Berg teaches that the flavonoid taxifolin, like EGCG and quercetin (see page 12, in particular lines 24-30) is effective in treating coronavirus infections (i.e. COVID-19, see page 2, line 6)) in the presence of zinc ions, in particular zinc picolinate (see page 21, line 32).
Further, Trofimova teaches that taxifolin (Dihydroquercetin or DHQ) when complex with zinc and copper ions increases its antiviral efficacy. Among the copper salts they mention copper sulfate (see page 1431 (left column, second line of second paragraph).
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to combine several compositions (taxifolin, quercetin, EGCG, zinc picolinate and copper sulfate) each of which, alone or in combination, is taught by the prior art to be useful for the same purpose (treating COVID-19), in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from there having been individually taught in the prior art (see MPEP 2144.06). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See also: In re Diamond, 360 F.2d 214, 53 C.C.P.A. 1172, 149 U.S.P.Q. 562 (C.C.P.A.1966).
All this would result in the practice of claims 41, 44-45 and 48 with a reasonable expectation of success.
For claims 50-51 Park teaches to either consume flavonoids and zinc as dietary supplements or by eating a variety of fruits and vegetables, thus resulting in the practice of claims 50-51 with a reasonable expectation of success.
2) Claim(s) 42-43, 46 and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brady (Functional Medicine blog retrieved from the internet: https://viorlife.com/the-natural-alternative-to-hydroxychloroquine/ (March 21, 2020) cited by Applicant) and Park (retrieved from https://medium.com@jayparkmd/covid-19-alternative-treatments-3b204d3155df (July 21, 2020), cited by Applicant) in view of Berg et. al (WO 2002/09699 February 7, 2002, cited by Applicant) and Trofimova et. al. (Russian Chemical Bulletin (2015) 64:1430-1436, cited by Applicant) as applied to claims 41, 44-45, 48 and 50-51 above, further in view of Tutunchi et. al. (Phytotherapy Research (2020) 34:3137-3147, cited by Applicant).
For claims 42-43, 46 and 49, Berg further teaches that the flavonoid naringenin, like EGCG, quercetin and taxifolin (see page 12, in particular lines 24-30) is effective in treating coronavirus infections (i.e. COVID-19, see page 2, line 6).
Further, Tutunchi teaches that Naringenin is effective in treating COVID-19 (see title and entire reference)
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to combine several compositions (taxifolin, quercetin, EGCG, zinc picolinate, copper sulfate and naringenin) each of which, alone or in combination, is taught by the prior art to be useful for the same purpose (treating COVID-19), in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from there having been individually taught in the prior art (see MPEP 2144.06). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See also: In re Diamond, 360 F.2d 214, 53 C.C.P.A. 1172, 149 U.S.P.Q. 562 (C.C.P.A.1966).
All this would result in the practice of claims 42-43, 46 and 49 with a reasonable expectation of success.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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, Amy L. Clark can be reached on 571 272-1310. 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.
/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
November 4, 2025.