DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Amendments and Remarks, filed 27 April 2026, in the matter of Application N° 17/997,674. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 2, 6, 12, 20, 21, and 93-102 are pending, where claims 2, 6, and 20 remain withdrawn from consideration.
Claim 26 has been canceled. Claims 93-102 are newly added and are supported by the originally-filed disclosure.
Claim 2 was amended in the submission filed 13 February 2026 and removed options (a) through (c), leaving only option (d). As option 2(d) was indicated as being drawn to non-elected subject matter (i.e., the species of an additional therapy), claim 2, as presently amended, is now withdrawn from consideration. Previously recited options (a) through (c) are newly presented in claims 93-95.
Claim 21 was also amended in the submission filed 13 February 2026 and removed options (b) through (e). Options (c) through (e) are newly presented in claims 99-101.
Claim 26 was canceled and newly presented as claim 102 depending from claim 101.
No new matter has been added.
Thus, claims 1, 21, and 93-102 now represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statements (IDS) have been filed for consideration.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 20 August 2025 since the art that was previously cited continues to read on the amended and previously recited limitations.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 21, 93-96, 98, and 99 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trofimova et al. (RU 2716504 C1; machine translation attached and cited). [emphasis added to reflect canceled/added claims]
The limitations of instant claim 1 recite a method of treating excessive production of one or more cytokines in an individual, comprising the step of administering to the individual, a therapeutically effective amount of Sphagnum, Sphagnum extract, a preparation of Sphagnum, a composition derived from Sphagnum, or a combination thereof. Claims 93-95 respectively recite that (a) the Sphagnum extract is an ethanol, methanol, and/or aqueous extract of Sphagnum; (b) the preparation of Sphagnum comprises tolpa peat preparation; and (c) the composition derived from Sphagnum comprises humic acid and/or fulvic acid.
Trofimova discloses the use of water-soluble humic acids isolated from high-moor Magellanicum peat as a means for stimulating the development of Th1-dependent immune response reactions by regulating the balance of activation of the pro-inflammatory properties of macrophages secreting IL-1β, IL-12, and TNFα cytokines and the anti-inflammatory properties of macrophages that produce IL-10 cytokines (see Abstract; claim; ¶[0004]). The foregoing is considered to teach the limitations recited by option (c) of claim 21.
The reference is thus considered to expressly disclosed the claimed invention.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1, 21, and 93-99 under pre-AIA 35 USC 102(a)(1) as being anticipated by Trofimova et al. have been fully considered, but are not persuasive.
Applicants traverse the rejection on the grounds that the instantly claimed method is directed to treating excessive production of one or more cytokines in an individual. Trofimova, on the other hand, is asserted as teaching immunostimulation of Th1-dependent responses by stimulating production of IL-1β, IL-12, and TNF-α by macrophages. Applicants argue that the reference teaches away.
The Examiner, in response, respectfully disagrees and maintains the rejection for the reasons already made of record. Specifically, the Examiner disagrees that production of the foregoing cytokines is necessarily stimulated. In fact, the Abstract, for instance, discloses that the TH1-dependent immune response is developed by controlling the balance of activation of pro-inflammatory properties of macrophages secreting IL-1β, IL-12, and TNF-α; the resulting effect is taught as producing selective stimulation of IL-1β, IL-12, and TNF-α.
Thus, for these reasons, Applicants’ arguments are found unpersuasive. The above rejection is hereby maintained and extended to include the limitations of newly presented claims 93-99.
Claim 93 recites that the Sphagnum extract is an ethanol extract of Sphagnum, a methanol extract of Sphagnum, and/or an aqueous extract of Sphagnum.
Claim 94 recites that the preparation of Sphagnum comprises tolpa peat extraction.
Claim 95 recites that the composition derived from Sphagnum comprises humic and/or fulvic acid.
Claim 98 recites that the composition is formulated as an aqueous solution or suspension.
The foregoing disclosure of Trofimova meets the newly required limitations, as the administered composition discloses a water-soluble humic acid composition prepared from Highmoor peat Magellanicum (aka Sphagnum magellanicum or Magellanic bogmoss) (see e.g., Abstract).
The limitations of claim 96 recite that the properties of administering the composition are reduction of TNF-α production by monocytes (macrophage), reduction of peripheral mononuclear cells, and/or reduction of dendritic cells stimulated with lipopolysaccharide.
The Examiner submits that the first condition is met, as discussed above (i.e., controlling the balance of activation).
The limitations of claim 99 are met by the foregoing disclosure of interleukin 1 beta, interleukin 6, and TNF-alpha.
Claims 1, 93-96, 98, and 101 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Dekker et al. (USPN 6,569,900 B1; US publication of EP 1 700 599 B1). [emphasis added to reflect canceled/added claims]
The limitations of claims 1, 93-95, and 98 are discussed above.
Dekker discloses a method of treating a subject presenting inflammation comprising administering fulvic acid (see e.g., claim 1). One of the disclosed effects of administering oxifulvic acid is that it causes a statistically significant decrease in interleukin 2 (IL-2) cytokine levels.
The reference is thus considered to expressly disclosed the claimed invention.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1, 93-95, 98, and 101 under pre-AIA 35 USC 102(a)(1)/(a)(2) as being anticipated by Dekker et al. have been fully considered, but are not persuasive.
Applicants traverse the rejection on the grounds that Dekker does not disclose Sphagnum, Sphagnum extracts, or compositions prepared from Sphagnum as required by Applicants’ claim 1.
The Examiner, in response, respectfully maintains the rejection and submits that the instantly recited invention is directed to treating an individual comprising the step of administering a composition that is ultimately defined as comprising humic acid, fulvic acid, or a combination of the two. The Examiner respectfully points out that the method of manufacturing is not considered to contribute to the overall patentability of the administered composition, absent a clear showing of evidence to the contrary. See MPEP §2113. Therein, the Examiner has demonstrated that fulvic acid is administered. Though the origin of it is not expressly disclosed, the Examiner advances that no distinction between the fulvic acid of Dekker and that which is instantly claimed is demonstrated.
Thus, for these reasons, Applicants’ arguments are found unpersuasive. The above rejection is hereby maintained and extended to include the limitations of claims 93-95, 98, and 101.
Therein, the limitations of claims 93 and 94 are considered to be met with the showing of fulvic acid for the reasons discussed above. The limitations of claims 95 and 98 are expressly met by the reference.
The limitations of claim 101 recite that the treated individual has a viral infection. Such is disclosed by the reference (see e.g., Abstract; claim 1).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Applicants are 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, 21, and 93-102 are rejected under 35 U.S.C. 103 as being unpatentable over Trofimova et al. (RU 2716504 C1; machine translation attached and cited) in view of Pedersen et al. (JCI; published 27 March 2020). [emphasis added to reflect canceled/added claims]
Trofimova discloses the use of water-soluble humic acids isolated from high-moor Magellanicum peat as a means for stimulating the development of Th1-dependent immune response reactions by regulating the balance of activation of the pro-inflammatory properties of macrophages secreting IL-1β, IL-12, and TNFα cytokines and the anti-inflammatory properties of macrophages that produce IL-10 cytokines (see Abstract; claim; ¶[0004]). The foregoing is considered to teach the limitations recited by option (c) of claim 21.
Where Trofimova is deficient is with respect to claim 26 whereby the viral infection is a coronavirus infection or is an infection of SARS-CoV-2.
Pedersen is considered to remedy the above deficiency in its teachings which connect SARS-CoV-2/COVID-19 to a cytokine storm. Therein, Figure 1 (pg. 2203) depicts the different symptoms and internal effects associated with severe COVID-19. Of particular note is that with severe COVID-19, there is a marked uptick in production of cytokines: IL-6, IL-2R, IL-10, and TNFα. The reference additionally discloses that “[i]n SARS-CoV-2-infected individuals, interleukin 6 (IL-6), IL-10, and tumor necrosis factor α (TNF-α) surge during illness and decline during recovery” and that “[s]erum cytokine levels and analysis of lymphocyte composition on admission suggest that SARS-CoV-2 infection is associated with lymphopenia (particularly in CD4+ T cells and CD8+ T cells but not in B cells), overproduction of cytokines (IL-6, soluble IL-2 receptor [IL-2R], IL-10, and TNF-α), and decreased IFN-γ expression in CD4+ T cells in severe COVID-19, which correlated with disease severity of COVID-19 (Figure 1). Levels of IL-6, IL-2R, IL-10, and TNF-α were mildly elevated or within the normal range in moderate cases, but markedly elevated in most of the severe cases.” [emphasis added] (see pg. 2204, left col.).
The Examiner acknowledges that Pedersen does not focus on or disclose any methods or compositions to treat an elevated presence of cytokines that result from SARS-CoV-2 or COVID-19, despite providing a clear association between the two. Trofimova, is similarly acknowledged as being deficient in connecting the overproduction of cytokines with SARS-CoV-2.
However, based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at achieving the recited method of treatment, particularly since modulation of the levels of cytokines such as IL-6, IL-2R, IL-10, and TNF-α are disclosed as being impacted by humic acid administration.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1, 21, and 93-102 under 35 USC 103(a) as being unpatentable over the combined teachings of Trofimova et al. and Pedersen et al. have been fully considered, but they are not persuasive.
Applicants reiterate the same grounds of traversal for Trofimova as above. Pedersen’s are also traversed on the grounds that they do not disclose any compositions or methods to treat cytokine storm, simply providing observations correlating severe COVID-19 with elevated cytokines.
Applicants also argue that neither Trofimova nor Pedersen suggest using Sphagnum materials to reduce excessive production of one or more cytokines and Trofimova’s teaching to stimulate pro-inflammatory cytokines would discourage their use as claimed.
The Examiner, in response, respectfully disagrees and maintains the rejection for the reasons discussed above.
Applicants’ arguments against Trofimova are unpersuasive for the reasons discussed above, namely that the reference discloses administration of humic acid increases the presence of cytokines. Instead, the Examiner maintains that administration of the extract balances production of the cytokines (i.e., includes reducing or suppressing production).
Applicants’ “objective evidence” in Figures 1 and 2 of the instant specification have been considered, but are respectfully not commensurate in scope with the claimed method.
Lastly, Applicants’ remark directed at new claim 102 states that it specifies coronavirus infection or SARS-CoV-2, while Pedersen only provides association data without treatment, and Trofimova neither addresses coronavirus cytokine storm nor suggests reducing cytokines in that context.
As discussed in the above rejection, Trofimova teaches administering humic acid (Sphagnum extract) to balance (i.e., reduce, suppress, etc.) cytokine production. Though it does not expressly correlate cytokine reduction to coronavirus treatment, Pedersen bridges this gap by disclosing the association. Thus, a person of ordinary skill in the art understanding that cytokine production may be suppressed through the administration of humic acid, would reasonably expect successful treatment of a patient’s COVID-19 borne cytokine storm via humic acid administration.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained and extended to include the newly presented limitations of claims 93-102.
The limitations of claims 93-96, 98, 99, 101, and 102 are discussed above.
The limitations of claims 96 and 97 are discussed above, and are considered by the Examiner as teaching and suggesting the recited properties of the claims. See MPEP §2112.01(II). Therein, it is stated that “[t]he discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using” and that “when the claim recites using an old composition or structure and the ‘use’ is directed to a result or property of that composition or structure, then the claim is anticipated.”
All claims under consideration are rejected; no claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicants are 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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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