DETAILED ACTIONStatus of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-18 are pending.
Claim Rejections - 35 USC §103
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 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.
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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hawthorne et al. (WO2017176762A1) hereinafter Hawthorne in view of Bae et al. (“Surface functionalized hollow manganese oxide nanoparticles for cancer targeted siRNA delivery and magnetic resonance imaging”, Biomaterials 32 (2011) 176-184) hereinafter Bae and Chen et al. (“Nanotherapies for sepsis by regulating inflammatory signals and reactive oxygen and nitrogen species: New insight for treating COVID-19”, RedoxBiology45(2021)102046).
Regarding claims 1-18, Hawthorne is drawn to compositions that bind to and inhibit the biological activity of soluble biomolecules, as well as pharmaceutical compositions thereof. The compositions may comprise a plurality of particles that specifically bind a target, such as a soluble biomolecule or a biomolecule on the surface of a pathogen, to inhibit the target (or pathogen) from interacting with other molecules or cells (abstract), wherein the particle comprises metal (claim 46, 47, 49);
Hawthorne discloses a cross-linking agent can be metal oxides (p71, In 9-10).
Hawthorne discloses in Example 3, a method for treating a viral infection, wherein the patient is administered a composition comprising particles that bind to and sequester soluble HIV-1 virions in an amount effective to reduce titers of the virus in the patient's circulation. The patient is given "maintenance doses" of the composition to maintain reduction of HIV- 1 virion titers and thereby suppress the infection in the patient (p107, In 14-20).
Hawthorne discloses the particles can be designed to bind to microorganisms (e.g. viruses or bacteria) or components of microorganisms, such as endotoxin. Accordingly, the particles described herein can be useful to treat, e.g. an infectious disease, e.g. viral infectious diseases (p95, In 30-p96, In 3).
Hawthorne discloses wherein the target of the particle is a viral protein (claim 67). Hawthorne discloses for delivery in vitro, such as to and/or around cells or tissues in culture, compositions may be added to the culture media, such as to contact the microenvironment or contact soluble material in the culture media or to contact the cell or even to penetrate the cell (p75, In 14-17).
Hawthorne does not specifically teach an anionic manganese oxide (MnO) nanoparticle or wherein the viral infection is caused by SARS-CoV-2.
However, Bae is drawn to multifunctional hollow manganese oxide nanoparticles (HMON) produced by a bio-inspired surface functionalization approach, using 3,4-dihydroxy-L-phenylalanine (DOPA) as an adhesive moiety, for cancer targeted delivery of therapeutic siRNA'; Note, MnO nanoparticles are anionic (abstract).
However, Chen discloses SARS-CoV-2 has caused up to 127 million cases of COVID-19. Approximately 5% of COVID-19 patients develop severe illness, and approximately 40% of those with severe illness eventually die, corresponding to more than 2.78 million people. The pathological characteristics of COVID-19 resemble typical sepsis, and severe COVID-19 has been identified as viral sepsis. Progress in sepsis research is important for improving the clinical care of these patients. Recent advances in understanding the pathogenesis of sepsis have led to the view that an uncontrolled inflammatory response and oxidative stress are core factors. To help bridge this gap, we discuss the pathogenesis of sepsis related to inflammation and the overproduction RONS, which activate pathogen-associated molecular pattern (PAMP)-pattern recognition receptor (PRR) and damage-associated molecular pattern (DAMP)-PRR signaling pathways. We also summarize the application of nanomaterials in the treatment of sepsis. As highlighted here, this strategy could synergistically improve the therapeutic efficacy against both RONS and inflammation in sepsis and may prolong survival (Abstract). Hawthorne discloses the target may be a viral protein. The viral protein may be from coronavirus (Hawthorne: p97, In 1-3).
Hawthorne discloses the particles are useful as anti-viral therapies, e.g., for a subject infected with a virus or at risk of being infected with a virus'), and further teaches nucleic acid-containing PAMPs (p20, In 33-p21, In 2). Hawthorne discloses "Pathogen- associated molecular patterns (PAMPs) include double-stranded RNA (viral) (p72, In 32-p73, In 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Hawthorne, wherein the metal oxide particles are manganese oxide nanoparticles, as previously disclosed by Bae, wherein the infection is caused by SARS-CoV-2, as previously disclosed by Chen, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Hawthorne, Bae, and Chen are all in the field of delivery of metal containing particles for therapeutic treatment, and Bae discloses multifunctional hollow manganese oxide nanoparticles (abstract), and Chen discloses the application of nanomaterials in the treatment of sepsis. As highlighted here, this strategy could synergistically improve the therapeutic efficacy against both RONS and inflammation in sepsis and may prolong survival (Abstract). Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUANGLONG N TRUONG whose telephone number is (571)270-0719. The examiner can normally be reached on 8:00 am-5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUANGLONG N TRUONG/Examiner, Art Unit 1615