DETAILED ACTION
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 .
Applicant’s amendment filed on December 31, 2025 is acknowledged. Claims 1-4, 7-8, 10-13, 16, 19-20, 24, and 29-44 are pending and under examination in this Office action.
Claim Rejections - 35 USC § 102
Rejection of Claims 1, 4, 7-8, 12, 16, 19, 20, 24, 32-44 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Johnson (US Patent Application Publication US 2018/0008703) is withdrawn in view of Applicant’s amendment.
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.
Claims 1-4, 7-8, 10-12, 16, 19-20, 24, and 29-44 are rejected under 35 U.S.C. 103 as being obvious over Johnson (US Patent Application Publication US 2018/0008703).
Johnson teaches an intracutaneous delivery system comprising a plurality of microprojections adapted to penetrate the stratum corneum of human skin comprising a therapeutically effective amount of a protein vaccine against SARS (severe acute respiratory syndrome) of influenza and methods for vaccinating a human patient comprising providing an intracutaneous delivery system (see claim 22, Example 7, paragraphs [0028], [0036], [0044-0086]).
Applicant amended the claims to add “wherein at least part of the microprojections comprise a shape of an arrowhead or an obelisk and are comprised of titanium”
It is noted that Johnson expressly teaches titanium microprojections/needles (see paragraph [0050]).
It is the Examiner’s position that the stepped pyramidal or triangular pyramidal shape needle disclosed in Johnson (see paragraph [0054-0056]) reads on the presently recited obelisk shape. In case the obelisk shape is not the same as stepped pyramidal or triangular pyramidal shape needle disclosed in Johnson, the obelisk shape would have been prima facie obvious to the skilled artisan, in view of the teachings in Johnson.
[0050] In some embodiments, the microneedle material can be (or include) silicon, glass, or a metal such as stainless steel, titanium, or nickel titanium alloy. In some embodiments, the microneedle material can be (or include) a polymeric material, preferably a medical grade polymeric material. Exemplary types of medical grade polymeric materials include polycarbonate, liquid crystalline polymer (LCP), polyether ether ketone (PEEK), cyclic olefin copolymer (COC), polybutylene terephthalate (PBT). Preferred types of medical grade polymeric materials include polycarbonate and LCP.
[0054] A microneedle or the plurality of microneedles in a microneedle array useful for practicing the present disclosure can have a variety of shapes that are capable of piercing the stratum corneum. In some embodiments, one or more of the plurality of microneedles can have a square pyramidal shape, triangular pyramidal shape, stepped pyramidal shape, conical shape, microblade shape, or the shape of a hypodermic needle. In some embodiments, one or more of the plurality of microneedles can have a square pyramidal shape. In some embodiments, one or more of the plurality of microneedles can have a triangular pyramidal shape. In some embodiments, one or more of the plurality of microneedles can have a stepped pyramidal shape. In some embodiments, one or more of the plurality of microneedles can have a conical shape. In some embodiments, one or more of the plurality of microneedles can have a microblade shape. In some embodiments, one or more of the plurality of microneedles can have the shape of a hypodermic needle. The shape can be symmetric or asymmetric. The shape can be truncated (for example, the plurality of microneedles can have a truncated pyramid shape or truncated cone shape). In a preferred embodiment, the plurality of microneedles in a microneedle array each have a square pyramidal shape.
[0055] In some embodiments, the plurality of microneedles in a microneedle array are solid microneedles (that is, the microneedles are solid throughout). In a preferred embodiment, the plurality of microneedles in a microneedle array are solid microneedles. In some embodiments, the plurality of solid microneedles in a microneedle array can have a square pyramidal shape, triangular pyramidal shape, stepped pyramidal shape, conical shape, or microblade shape. In a preferred embodiment, the plurality of solid microneedles in a microneedle array each have a square pyramidal shape.
[0056] In some embodiments, the plurality of microneedles in a microneedle array are hollow microneedles (that is, the microneedles contain a hollow bore through the microneedle). The hollow bore can be from the base of the microneedle to the tip of the microneedle or the bore can be from the base of the microneedle to a position offset from the tip of the microneedle. In some embodiments, one or more of the plurality of hollow microneedles in a microneedle array can have a conical shape, cylindrical shape, square pyramidal shape, triangular pyramidal shape, or the shape of a hypodermic needle.
Regarding claims 7 and 19, Johnson discloses a surfactant (see paragraph [0034]).
Regarding claim 8, Johnson discloses sucrose and theralose (see paragraph [0029]).
Regarding claims 35-40. Johnson disclosed the penetration length of between 50 to 1200 micrometers (see paragraphs [0064-0068]).
Regarding claims 12, 13, 14, 30, 38, 40-41, and 43-44. Johnson discloses a method of vaccinating a human patient against influenza virus comprising providing an intracutaneous delivery system adapted to penetrate the stratum corneum of human skin (see paragraphs [0010-0011] and [0052-0054]).
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Rejection of Claim 13 under 35 U.S.C. 102(a)(2) as being obvious by Johnson (US Patent Application Publication US 2018/0008703) in view of Niazi et al. (US Patent Application Publication US 2023/0302121) is maintained.
Johnson discloses the present invention as discussed above.
Johnson teaches SARS but does not teach COVID-19 or the time within with the vaccine is released, the vaccine stability or the length of penetration.
Niazi et al. teach methods of vaccinating a human subject against COVID-19 (see claims 1-22).
It would have been prima facie obvious to one of skill in the art to use Johnson’s device system to deliver Niazi’s COVID-19 vaccine because Niazi teaches vaccination with COVID-19 antigen to immunize an individual against COVID-19 infection.
It would have been within the skill of the ordinary artisan to determine the timing of the vaccine release into the patient’s skin.
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Response to Applicant’s arguments
Applicant argues that Niazi merely concerns coronavirus vaccines. In response, Examiner notes that there is ample and extensive support for COVID-19 vaccine in Niazi’s specification (see excerpts below). Thus, in view of the foregoing the rejection is maintained.
[0003] The present disclosure relates to composition, systems, and methods of treating subjects diagnosed or suspected to have Coronavirus Disease 2019 (COVID-19).
[0006] After several noteworthy coronavirus outbreaks in the recent years, including SARS and MERS, COVID-19 is yet another example of a serious infectious disease precipitated by a member of the corona virus family. While diagnostic tests have become available in relatively short time, numerous attempts to treat the disease have so far not had significant success. Most typically, patients with severe symptoms are treated to maintain respiration/blood oxygenation and supportive treatment is provided to reduce or prevent multi-organ damage or even failure. Despite such interventions, the mortality rate is significant, particularly in elderly, immune compromised individuals, and individuals with heart disease, lung disease, or diabetes.
[0007] Thus, even though various methods of addressing symptoms win patients with COVID-19 are known in the art, all or almost all of them suffer from various disadvantages. Consequently, there is a need to provide improved compositions and methods that provide therapeutic effect, that reduce or prevent viral entry into a cell, reduce direct and indirect toxicity of the virus to the patient, and that produce an immune response that is effective to clear the virus from the patient.
[0016] In some preferred embodiments, the coronavirus disease is COVID-19.
[0017] In yet another aspect of the present disclosure, disclosed herein is a vaccine formulation comprising a recombinant entity, wherein the recombinant entity comprises a nucleic acid that encodes a nucleocapsid protein of coronavirus 2 (CoV2); and/or wherein the recombinant entity encodes a spike protein of CoV2. As discussed throughout, the recombinant entity is preferably a recombinant adenovirus or Saccharomyces cerevisiae. The vaccine formulation may be administered to a patient having a coronavirus disease for treatment and/or prevention of the coronavirus disease.
0025] FIG. 7 exemplarily depicts that recovered COVID-19 patient plasma recognizes antigens expressed by NANT's RBD-ETSD and NANT fusion S/N-ETSD constructs.
[0037] Also disclosed herein are methods for preventing and/or treating coronavirus diseases, and especially COVID-19. Preferably, the method includes using a viral or yeast vector that encodes the nucleocapsid protein and/or spike protein of the coronavirus in an immunogenic composition that is administered to a subject individual. The virus and/or yeast vaccine, thus administered, would infect the individual with CoV2 nucleocapsid or spike protein. With that in place, the individual would have an immune response against it, and be vaccinated. Notably, as the nucleocapsid protein and the spike protein are relatively conserved polypeptides, immune responses can be elicited for a varie 0073] Disclosed herein are constructs that have been constructed and tested, a hAd5-COVID-19 vaccine construct E1-, E2b-, E3-hAd5 vector with SARS-CoV-2 (S/N) protein insert (FIG. 1). This construct has been tested in preclinical experiments, including in vitro expression (FIG. 2) and small animal immunogenicity.
[0074] In addition, ImmunityBio has developed multiple COVID-19 constructs including RBD-alone, S1-alone, S1-fusion proteins, and combinations of RBD, S1 and S1 fusions with N. Preliminary in-vitro studies demonstrate that these constructs (FIG. 3) recognize convalescent serum antibodies and could serve as alternative vaccines following analysis of the two (2) constructs above (FIG. 1) which is intended to initiate in our first in human Phase 1b study. ty of members of the coronavirus family.
Contact Information
Applicant’s amendment necessitated new grounds of rejection present in this Office
action. Thus, THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648