CLAIMS 1-12, 33-47, 49 AND 51 ARE PRESENTED FOR EXAMINATION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, has been examined under the first inventor to file provisions of the AIA .
Applicant’s Preliminary Amendment filed April 12, 2022 and Information Disclosure Statements filed June 20, 2022 and April 22, 2023 have been received and entered into the application.
Accordingly, the application papers have been amended as directed. Also, as reflected by the attached, completed copies of form PTO/SB/08, the cited references have been considered by the Examiner.
As per the restriction requirement set forth in the Office action dated October 07, 2025, Applicant has elected, without traverse, the invention of Group V., claims 40-45 and 47, directed to a method of treating a patient or subject in need at risk for or affiliated with anthrax or severe acute respiratory syndrome coronavirus infection, (SARS or SARS CoV2).
The requirement is deemed to remain proper for the reasons of record and is hereby made FINAL.
Claims 1-12, 33-39, 46, 49 and 51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 40-45 and 47 are herein acted on the merits.
Prior Art Cited by the Examiner
The Examiner has cited S. Shin et al., "Involvement of phospholipase A₂ activation in anthrax lethal toxin-induced cytotoxicity", Cell Biology and Toxicology. 1999; 15: 19-29, to show the state of the art regarding anthrax toxicity and PLA2 inhibitors such as quinacrine, bromophenacyl bromide, manoalide and butacaine.
Shin et al. teach in the abstract and show in their data PLA2 inhibitors inhibited, in vitro in a dose-dependent fashion, the cytotoxicity associated with anthrax lethal toxin. In the last paragraph of their article, (col. 2, pg. 27), the authors conclude “the results obtained in this
study indicate that one of the cytotoxic mechanisms of anthrax lethal toxin may involve activation of PLA₂…[and that] [t]he results of the present study should encourage attempts
to develop methods of prevention and therapy of anthrax lethal toxin toxicity.”.
The reference does not anticipate nor would have made obvious the presently claimed subject matter because (a) the reference fails to teach at least the step of administering to a patient a PLA2 inhibitor, i.e., no anticipation, and (2) that the authors state that their results should “encourage attempts to develop methods of prevention and therapy of anthrax lethal toxin” appears too speculative to have motivated one of ordinary skill in the art to do what applicant is here doing in at least claim 40 with a reasonable expectation of success whereby the administration of an effective amount of a PLA2 inhibitor to a patient in need, at risk for or afflicted with anthrax, without or without concomitant antibiotic therapy, results in the inhibition, amelioration and/or avoidance of sepsis, septic shock, acute inflammatory syndrome and/or acute respiratory distress syndrome in the patient, i.e., would not have been obvious.
Claim Objection
Claims 44 and 47 are objected as depending from a rejected base claim, but are otherwise in condition for allowance.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) Claims 40, 41, 43 and 45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alibek et al., (US 20070231334 A1, cited by Applicant, hereinafter “Alibek”).
Alibek teaches a method for treating anthrax infection in a human or an
animal subject comprising administering to the subject a therapeutically effective amount of a
composition comprising at least one B. anthracis MP inhibitor (claim 26) or a therapeutically
effective ratio of at least one B. anthracis MP inhibitor multiple antibiotics, (“a broad range of antibiotics may be co-administered with the B. anthracis MP inhibitor…”, [0042]), wherein the antibiotic is selected from a group consisting of fluoroquinolones, tetracyclines, and B lactams (claims 31-32). In particular, the antibiotic is ciprofloxacin or doxycycline (where here the doxycycline satisfies the present requirement for a metalloproteinase inhibitors of present claim 45), (Alibek at claim 33). The MP inhibitor is, in particular, EDTA or o-phenanthroline, that indicated in the list of possible MP inhibitors for use in this application (p. 44). Example 7 (with Fig. 5A-5C) discloses unexpected increasing % survival model animals (mice), and, in particular, the suppressing the hemorrhagic effect, which relates to inflammatory response syndrome (SIRS).
(B) Claims 40 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over SHEN LW, et al. TMPRSS2: A potential target for treatment of influenza virus and coronavirus infections. Mini-review, Biochimie, 2017;142:1-10 https://doi.org/10.1016/j.biochi.2017.07.016.
Shen et al. (p.4, left column) disclose a method for treating a subject at risk for or afflicted severe acute respiratory syndrome coronavirus infection (SARS), comprising administering camostat, which is a PLA2 inhibitor and a serine protease inhibitor which can effectively protect mice infected with the otherwise lethal SARS-CoV from death, i.e. inherently provides an unexpected amelioration and/or avoidance of acute inflammatory syndrome, including inflammatory response syndrome (SIRS) and/or acute respiratory distress syndrome (ARDS).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYMOND J HENLEY III whose telephone number is (571)272-0575. The examiner can normally be reached M-F 6-2:30pm EST.
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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629 May 26, 2026
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