DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ response to the Requirement for Restriction, filed 6 August 2025, 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 28, 29, 33, 39, 47-50, 53, 59, 67-70, 73, 79, 87, and 89-92 have been canceled.
No claims have been added.
Claims 6 and 21 have been amended to address the previously raised objections.
No new matter has been added.
Applicants’ election of Group I (claims 1, 2, 6, 12, 20, 21, and 21) is acknowledged.
Applicants’ species election for no additional therapy is acknowledged.
However, because Applicants did not distinctly and specifically point out the supposed errors in the restriction or species requirements, the elections have both been treated as elections without traverse (MPEP §818.01(a)).
Applicants’ election is made FINAL. In addition to the canceled claims of Groups: II-IV, claims 2(d), 6, 12, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected species of the invention, there being no allowable generic or linking claim. Applicants timely traversed the restriction requirement between the methods.
Thus, claims 1, 2, 21, and 26 are presented and represent all claims currently under consideration.
Information Disclosure Statement
One Information Disclosure Statement (IDS) filed 1 November 2022 is acknowledged and has been considered.
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, 2, and 21 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).
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. Claim 2, as elected, recites 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/or (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.
Claims 1 and 2 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).
The limitations of claims 1 and 2 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.
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, 2, 21, and 26 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).
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.
All claims have been rejected; no claims are allowed.
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