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 application is a national stage application of PCT/US2022/046404, filed October 12, 2022, which claims benefit of provisional applications 63/347715, filed June 1, 2022, and 63/255336, filed October 13, 2021. Claims 1-24 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted November 5, 2024, is acknowledged wherein claims 6 and 12 are amended.
Information Disclosure Statement
The information disclosure statement filed September 23, 2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
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 23 and 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because it is unclear what category a “use” as described in these claims, described in the absence of clearly defined method steps, belongs to.
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.
Claims 1, 3, 4, 6, and 15-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Al-Beltagi et al. (Reference included with PTO-892)
Independent claim 1 is directed to a method for treating a condition such as a viral disease comprising administering either an inhibitor of the tricarboxylic acid cycle or a compound that activates the unfolded protein response. (UPR) Dependent claim 4 specifically requires that the active compound is tunicamycin or thapsigargin. Al-Beltagi et al. discloses that thapsigargin (TG) is an antiviral compound that works by activating the unfolded protein response. (p. 2 third paragraph) TG was found to have antiviral activity against RSV, Coronavirus OC43, SARS-CoV2, and influenza A virus. (pp. 5-15 sections 3.1-3.4) Therefore Al-Beltagi et al. anticipates the present claims. Regarding claim 23, this claim recites similar limitations and is seen to be anticipated for the same reasons.
Furthermore regarding the limitation in claim 1 that specifies that the UPR is induced in immune cells, while Al-Beltagi et al. does not specifically describe TG as acting on immune cells, it is seen that the prior art method comprising administering the same compound to the same subject population I order to achieve the same result described in the present application is reasonably considered to work by the same method described in the present disclosure. Similarly, the mechanistic limitations recited in present claims 6 and 15-22 are considered to be inherently present for the same reasons.
For these reasons Al-Beltagi anticipates the present claims.
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.
Claims 2, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Beltagi et al. (Reference included with PTO-892)
The disclosure of Al-Beltagi is discussed above. Al-Beltagi does not specifically disclose co-administering the compound with a corticosteroid such as dexamethasone or hydrocortisone. However, Al-Beltagi et al. discloses that these two compounds are administered to patients infected with SARS-CoV2 in order to modulate the cytokine storm. (p. 15 second paragraph) Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to administer these corticosteroids along with TG as described by Al-Beltagi. One of ordinary skill in the art would have found this to be obvious because it would be expected that the antiviral and anti-inflammatory effects of these two drugs would be complementary, addressing different aspects of COVID-19.
Therefore the invention taken as a whole is prima facie obvious.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Beltagi et al. as applied to claims 1-4, 6, 12, and 14-23 above, and further in view of Grandjean et al. (Reference included with PTO-892)
The disclosure of Al-Beltagi is discussed above. Al-Beltagi does not specifically disclose a method wherein the UPR activator is IXA4. However, Grandjean et al. discloses a screen of small molecules that activate the unfolded protein response through the IRE1-XBP1s pathway. (p. 1053 left column second paragraph) Compounds found to activate this pathway include IXA4. (p. 1054 left column, also figure 1) It would have been obvious to one of ordinary skill in the art at the time of the invention to administer this compound in place of TG as an antiviral compound in the methods described by Al-Beltagi et al. One of ordinary skill in the art would have seen the disclosures of these two reference as indicating that both compounds activate the UPR and are therefore equivalents usable for the same purpose.
Therefore the invention taken as a whole is prima facie obvious.
Claims 1, 2, 7-11, and 15-24 are rejected under 35 U.S.C. 103 as being unpatentable over Regev et al. (PCT international publication WO2020/191079, Reference included with PTO-892) in view of Omarjee et al. (Reference included with PTO-892)
Independent claim 1 is directed to a method for treating a condition such as a hypercytokinemia or cytokine storm comprising administering either an inhibitor of the tricarboxylic acid cycle or a compound that activates the unfolded protein response. (UPR) Dependent claims 7-10 specify the compound as being 6,8-bis-benzylthio-octanoic acid.
Regev et al. discloses a method for shifting T-cell balance from Th17 cells to Treg cells. (p. 3 paragraphs 9-10) In a specific embodiment this method is used to treat an inflammatory or autoimmune disorder. (p. 4 paragraph 13) In a particular embodiment the method involves administering a small molecule such as 6,8-bis-benzylthio-octanoic acid. (p. 6 paragraph 18) This compound is specifically described as shifting the balance of T cells away from Th17 pathogenicity. (p. 160 paragraph 465) Regev et al. does not specifically disclose administering this compound to a subject suffering from hypercytokinemia or cytokine storm.
However, Omarjee et al. discloses that onset of severe COVID-19 is characterized by a cytokine storm with hypersecretion of proinflammatory cytokines. (p. 2 left column fourth paragraph) The pathology of this condition is described as including autoimmunity, and a switch of T-cells to a Th2 profile, as well as expansion of Th17 cells. (p. 4 right column fourth paragraph – p. 5 left column fifth paragraph) The pathogenesis of cytokine storm is specifically compared with SLE, an autoimmune disease. (p. 5 right column) Omarjee et al. further discloses using small molecule therapies to target immunosenescence and prevent cytokine storm. (p. 5 left column third paragraph – p. 9 left column fourth paragraph)
It would have been obvious to one of ordinary skill in the art at the time of the invention to use Regev’s method to treat or prevent cytokine storm in a subject suffering from COVID-19. One of ordinary skill in the art would have seen the disclosure of Omarjee et al. as suggesting that this particular subject population suffered from a Th17-associated autoimmune pathology that would fall within the scope of conditions treatable by Regev’s method.
Therefore the invention taken as a whole is prima facie obvious.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Al-Beltagi et al. as applied to claims 1-4, 6, 12, and 14-23 above, and further in view of Revannasiddaiah et al. (Reference included with PTO-892)
The disclosure of Al-Beltagi is discussed above. Al-Beltagi et al. does not disclose a method further comprising administering an immunosuppressive agent such as cyclophosphamide.
Revannasiddaiah et al. discloses that dysregulated immune response in the later phases of SARS-CoV2 infection can lead to lung injury and ARDS. (p. 1 right column first paragraph) Revannasiddaiah et al. specifically suggests using cyclophosphamide as an immunosuppressive agent to treat patients suffering from ARDS. (p. 2 left column sixth paragraph – right column fifth paragraph)
It would have been obvious to one of ordinary skill in the art at the time of the invention to administer both the antiviral therapy described by Al-Beltagi et al. and the immunosuppressive therapy described by Revannasiddaiah et al. to a subject suffering from COVID-19 complicated by ARDS. One of ordinary skill in the art would have seen the prior art as suggesting that both of these therapies are useful in this patient population, suggesting their use together.
Therefore the invention taken as a whole is prima facie obvious.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Regev et al. in view of Omarjee et al. as applied to claims 1, 2, 7-11, and 15-24 above, and further in view of Revannasiddaiah et al. (Reference included with PTO-892)
The disclosures of Regev et al. and Omarjee et al. are discussed above. Regev in view of Omarjee does not disclose a method further comprising administering an immunosuppressive agent such as cyclophosphamide.
Revannasiddaiah et al. discloses that dysregulated immune response in the later phases of SARS-CoV2 infection can lead to lung injury and ARDS. (p. 1 right column first paragraph) Revannasiddaiah et al. specifically suggests using cyclophosphamide as an immunosuppressive agent to treat patients suffering from ARDS. (p. 2 left column sixth paragraph – right column fifth paragraph)
It would have been obvious to one of ordinary skill in the art at the time of the invention to administer both the therapeutic agent described by Regev et al. and the immunosuppressive therapy described by Revannasiddaiah et al. to a subject suffering from COVID-19 complicated by ARDS. One of ordinary skill in the art would have seen the prior art as suggesting that both of these therapies are useful in this patient population, suggesting their use together.
Therefore the invention taken as a whole is prima facie obvious.
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Regev et al. in view of Omarjee et al. as applied to claims 1, 2, 7-11, and 15-24 above, and further in view of Sharun et al. (Reference included with PTO-892)
The disclosures of Regev et al. and Omarjee et al. are discussed above. Regev in view of Omarjee does not disclose a method further comprising administering dexamethasone.
Sharun et al. discloses the use of the corticosteroid dexamethasone as an anti-inflammatory drug for treating COVID-19 associated cytokine storm. (p. 1 left column second paragraph)
It would have been obvious to one of ordinary skill in the art at the time of the invention to administer both the therapeutic agent described by Regev et al. and dexamethasone as described by Sharun et al. to a subject suffering from COVID-19 complicated by ARDS. One of ordinary skill in the art would have seen the prior art as suggesting that both of these therapies are useful in this patient population, suggesting their use together.
Therefore the invention taken as a whole is prima facie obvious.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 7/29/2026
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