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
Claims 1-2, 5-20 and 33-34 are pending and are under consideration in the instant office action.
Priority
This application claims the benefit of U.S. provisional application No.
63/085,745, which was filed September 30, 2020.
Claim Objections
Claims 5-9 are objected to under 37 CFR 1.75(c), as being of improper dependent form for failing to further limit the subject matter of a previous claim. Applicant is required to cancel the claim(s), or amend the claim(s) to place the claim(s) in proper dependent form, or rewrite the claim(s) in independent form. Claims 5-9 depends on cancelled claim 4, Appropriate correction is required.
In the instant office action, Claims 5-9 will be examined as reading on instant claim 1 which is directed to a pharmaceutical composition for intravenous delivery to a mammal, the pharmaceutical composition comprising magnesium sulfate, ascorbic acid, thiamine, and niacinamide at a ratio (w/w) of 72 to 108 magnesium sulfate:80 to 120 ascorbic acid:5.6 to 8.4 thiamine:10.4 to 15.6 niacinamide, and at least one anti-inflammatory drug selected from anti-inflammatory steroids, or a pharmaceutically acceptable salt thereof. Applicant is however required to correct the dependency.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of the fourth paragraph of 35 U.S.C. 112:
Subject to the following paragraph, a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 19 recites the limitation that the composition comprises dexamethasone. Furthermore, claim 19 depends on claim 17. Claim 17 recites that the composition comprises an anti-inflammatory steroid comprising dexamethasone. Therefore, claim 19 does not further limit claim 17. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirments.rm, or present a sufficient showing that
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. 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.
Claims 1-2, 5-20 and 33-34 are rejected under 35 U.S.C. 103(a) as being unpatentable over Uckun et al. (Clin, Invest, 24th June 2020, 10 (2) pages 45-52, hereinafter Uckun).
Instant claims are drawn to a pharmaceutical composition for intravenous delivery to a mammal, the pharmaceutical composition comprising magnesium sulfate, ascorbic acid, thiamine, and niacinamide at a ratio (w/w) of 72 to 108 magnesium sulfate:80 to 120 ascorbic acid:5.6 to 8.4 thiamine:10.4 to 15.6 niacinamide, and at least one anti-inflammatory drug selected from anti-inflammatory steroids, or a pharmaceutically acceptable salt thereof (claims 1-2 and 5-14), A method of treating an inflammatory condition in a mammal comprising administering to the mammal an effective amount of a pharmaceutical composition comprising magnesium sulfate, ascorbic acid, thiamine, and niacinamide at a ratio (w/w) of 72 to 108 magnesium sulfate:80 to 120 ascorbic acid:5.6 to 8.4 thiamine: 10.4 to 15.6 niacinamide (claims 15-20) and a method of treating COVID-19 comprising administering to a COVID-19 patient an effective amount of a pharmaceutical composition comprising magnesium sulfate, ascorbic acid, thiamine, and niacinamide at a ratio (w/w) of 72 to 108 magnesium sulfate:80 to 120 ascorbic acid:5.6 to 8.4 thiamine:10.4 to 15.6 niacinamide, preferably where the administering further comprises administering one or more anti-inflammatory agent, separately or as part of the pharmaceutical composition (claims 33-34).
Uckun teaches " RJX is an Intravenous (IV) formulation of known physiologically compatible compounds that is being developed for more effective supportive therapy of patients with sepsis, including COVID-19 patients with viral sepsis and Acute Respiratory Distress Syndrome (ARDS)... The RJX formulation is a solution of buffered acid products, electrolyte components, and vitamins, including ascorbic acid, cyanocobalamin, thiamine hydrochloride, riboflavin 5' phosphate, niacinamide, pyridoxine hydrochloride, and calcium d-pantothenate, and magnesium sulfate heptahydrate"; (abstract) "The combination of intravenous Vit. C, thiamine, and hydrocortisone in severe sepsis and septic shock reduces the case mortality by almost a third"). (pg 47 col 2 para 1). They further teach that several studies are underway to further evaluate the efficacy of Vit. C alone or in combination with thiamine and steroids in the treatment of severe sepsis and septic shock";( pg 48 col 1 para 1) and that the combination of Vit. B2 and thiamine have been shown to potentiate the anti-inflammatory activity of dexamethasone and reduce the production of TNF-a and IL- 6";). They further teach that the clinical development plan for RJX includes a Phase II study to evaluate its tolerability and activity in mild-moderate COVID-19 patients (pg 49 col 1 para 2). Uckun discloses the quantitative compositions of RJX which gices the content of each of the iredients in their inventive formulation pg 48 Table 1, “Quantitative Composition of RJX").
Uckun does not explicitly teach the agents at a ratio (w/w) of 72 to 108 magnesium sulfate:80 to 120 ascorbic acid:5.6 to 8.4 thiamine:10.4 to 15.6 niacinamide or wherein the one or more anti -inflammatory drug selected from anti-inflammatory steroids comprises dexamethasone at an amount of 0.75-40 mg per dose of the pharmaceutical composition
However, it would have been obvious to one of ordinary skill in the art to modify the amounts to a ratio (w/w) of 72 to 108 magnesium sulfate:80 to 120 ascorbic acid:5.6 to 8.4 thiamine:10.4 to 15.6 niacinamide by routine experimentation to optimize the therapeutic effect and it would have have been obvious to one of ordinary skill in the art to provide dexamethasone at an amount of 0.75-40 mg per dose of the pharmaceutical composition by routine experimentation to optimize the therapeutic effect (pg 48 col 1 para 1). As Uckun discloses the quantitative compositions of RJX which gives the content of each of the ingredients in their inventive formulation, which provides one of ordinary skill in the art a framework for dosage developments. Further It is noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Accordingly , the instant claims are prima facia obvious over the teachings of Uckun et al. They will be motivated by the teachings of Uckun to use the combination of agents as instantly claimed to create a composition for treatment as an anti-inflammatory therapy including for the symptoms of COVID. Absence of evidence to the contrary, a person of ordinary skill in the art will be imbued with a reasonable expectation of success, with motivation gleamed from the prior art in arriving at the instant claims.
Conclusion
Claims 1-2, 5-20 and 33-34 are rejected. No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dierdre (Renee) Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVITHA M RAO/Primary Examiner, Art Unit 1691