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 .
Priority
This application is a 371 of PCT/US2021/026750 (04/10/2021)
PCT/US2021/026750 has PRO 63/008,603 (04/10/2020).
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 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Greil et al. (Hematol Oncol, (2019) 37: 210-212.).
Greil teaches a method of treating hypercytokinemia in a subject (p. 211: “release of inflammatory cytokines in response to administration of certain drugs”) identified as having a high level of pro-inflammatory cytokine ( p. 211: “Cytokines evaluated were IFNγ, IL6, IL8, IL10, IL18, MCP1, MIP1α, MIP1β, and TNFα. Changes from baseline …”) by administration of ibrutinib (p. 211 ibr infusion).
Thus, Geil anticipates claims 8-10.
Claims 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smyth et al. (US20130338172).
Regarding claims 18-20, Smyth teaches a composition comprising ibrutinib and an agent to treat inflammation in a single dosage ([0533]: “Where the individual is suffering from … an inflammatory disease, … Compound 1 can be used in with one or more of the following therapeutic agents in any combination: immunosuppressants (e.g., tacrolimus, cyclosporin, rapamicin, methotrexate, cyclophosphamide, azathioprine, mercaptopurine, mycophenolate, or FTY720), glucocorticoids (e.g., prednisone, cortisone acetate, prednisolone, methylprednisolone, dexamethasone, betamethasone, triamcinolone, beclometasone, fludrocortisone acetate, deoxycorticosterone acetate, aldosterone), non-steroidal anti-inflammatory drugs (e.g., salicylates, arylalkanoic acids, 2-arylpropionic acids, N-arylanthranilic acids, oxicams, coxibs, or sulphonanilides), Cox-2-specific inhibitors (e.g., valdecoxib, celecoxib, or rofecoxib) … .”; where Compound 1 is ibrutinib “1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one”. [0436]-[0439]: ““fixed combination” means that the active ingredients, e.g. Compound 1 and a co-agent, are both administered to a patient simultaneously in the form of a single entity or dosage.” ).
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 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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Buggy et al. (US20140134265) in view of Florence et al. (Am J Physiol Lung Cell Mol Physiol 315: L52–L58, 2018.).
Regarding claim 1, Buggy teaches “methods and compositions comprising a covalent TEC family kinase inhibitor for use in adjuvant therapy, including adjuvant cancer therapy, vaccination and treatment of immune disorders and pathogenic infections” (Abstract) where the inhibitor is ibrutinib (claim 15; [0004]). Buggy teaches the method is useful for treating coronavirus infections ([0246]-[0256] treating viral infection; [0087], [0202]-[0206]: treating coronavirus infection).
Buggy does not teach a single embodiment where ibrutinib is administered to treat a coronavirus infection.
Florence teaches the success of ibrutinib in treating ARDS in mice having lethal influenza-induced acute lung injury (Title, p. L52, L55-57).
One of ordinary skill in the art following the teaching of Buggy in view of Florence would have recognized that ibrutinib would be successful in treating a coronavirus infection because Buggy specifically teaches ibrutinib is useful in treating coronavirus and Florence’s success in treating other viral infections. One of ordinary skill in the art would have had a reasonable expectation of success in view of the experimental demonstrations with the same compound and the specific teaching of Buggy.
Regarding claim 2-3, Buggy teaches the treatment of humans ([0005]: “In some embodiments, the mammal is a human.”).
Regarding claims 4-5, Buggy teaches identifying a biomarker ([0158], [0162], [0276]) which one of ordinary skill in the art would have reasonably considered applying to coronavirus infections and arrive at the claimed invention.
Claims 6-7, 8-11, 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Buggy et al. (US20140134265) in view of Florence et al. (Am J Physiol Lung Cell Mol Physiol 315: L52–L58, 2018.) as applied to claims 1-5 above and further in view of WHO (“Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected – Interim guidance”, 13 March 202, 4 pages, cited in IDS dated 2022-10-10).
Regarding claims 6-7, Buggy and Florence do not teach wherein the coronavirus infection is COVID-19, however, WHO teaches that COVID-19 is a coronavirus disease with complications including ARDS. One of ordinary skill in the art following the combined teaching of Buggy and Florence in view of WHO would have reasonably considered applying the combination to a COVID-19 infection, particularly because of the ARDS aspects of the condition.
Regarding claims 8-11, 14-17 with limitations characterizing aspects of disease including relating to cytokines and SARS-CoV-2, these limitations would be necessarily present in the obvious method of treating a COVID-19 infection as detailed above and thus renders these claims obvious for the same reasons.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Conclusion
No claims allowed.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626