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 .
Status of Application
Receipt of the Preliminary Amendment dated October 21, 2025 is acknowledged.
Claims 1-40 and 43-44 are pending in this application.
Claims 1-31, 33, and 35-40 have been amended.
Claims 41-42 have been cancelled.
Claims 43-44 are new.
All pending claims are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed on March 4, 2026 and October 24, 2026 is acknowledged. Signed copies are attached to this office action.
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.
Claims 34-36, 38-40, and 43-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by David et al. (US 2018/0078507; cited on IDS dated October 24, 2025).
David discloses a pharmaceutical composition comprising: a) a biodegradable polymeric composite particle comprising: at least one active agent encapsulated in a hollow or aqueous core by a shell comprising a mixture of a first polymer, wherein the first polymer is a hydrophobic polymer, and a second polymer, wherein the at least one active agent is released over a period of 7 days to 6 months; and b) at least one active agent free from and not encapsulated by the polymeric composite particle; wherein the at least one additional active agent provides an initial dose and the polymeric composite particle provides a delayed dose of the active agent, wherein the active agent encapsulated in the core and the active agent free from the particle can be the same active agent or different active agents (paragraph 0016).
Regarding claim 35, the active agent can be an antigen or a vector of a vaccine (paragraph 0020).
Regarding claim 36, the particle size can be from about 10 nanometers (nm) to about 100 micrometers (micron or μm) (paragraph 0043).
Regarding claim 38, the compositions and/or pharmaceutical formulations include a pharmaceutically acceptable excipient, diluent, carrier and/or adjuvant (paragraph 0101).
Regarding claim 39, in some embodiments, an adjuvant that is coencapsulated with an antigen will promote and enhance the hosts immune response to the antigen (paragraph 0100). An adjuvant and an antigen are considered to be pharmaceutical agents.
Regarding claim 40, as noted above, the active agent encapsulated in the core and the active agent free from the particle can be the same active agent or different active agents (paragraph 0016).
Regarding claims 43-44, the pharmaceutical compositions (comprising the particles) are used for delivering an antigen or vector for treating or preventing an infection or a disease caused by a pathogen or a non-pathogen target (paragraph 0106). The Examiner has interpreted delivering to include administration.
David, therefore, anticipates the rejected claims.
Claims 34-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kyekyoon et al. (WO 02/13786; cited on IDS dated October 24, 2025).
Kyekyoon discloses micro- and nano- sized spherical particles comprising encapsuled therapeutic compounds useful as biomedical compositions for medical treatment of humans and therapeutic value (page 6).
For example, a protein can be dissolved in an aqueous buffer solution while a polymer (the sphere forming material), can be dissolved in an organic solvent (page 19).
Nonlimiting examples of materials useful for particle formation include polyesters (such as poly(lactic acid), poly(glycolic acid) and poly(lactic-co- glycolic acid)), poly(lactic acid-co-lysine), poly(lactic acid-graft-lysine), polyanhydrides (such as poly(fatty acid dimer), poly(fumaric acid), poly(sebacic acid), poly(carboxyphenoxy propane), poly(carboxyphenoxy hexane), copolymers of these monomers and the like), poly(anhydride-co-imides), poly(amides), poly(ortho esters), poly(iminocarbonates), poly(urethanes), poly(organophasphazenes), poly(phosphates), poly(ethylene vinyl acetate) and other acyl substituted cellulose acetates and derivatives thereof, poly(caprolactone), polycarbonates), poly(amino acids), poly(acrylates), polyacetals, poly(cyanoacrylates), poly(styrenes), poly( vinyl chloride), poly( vinyl fluoride), poly( vinyl imidazole), chlorosulfonated polyolefins, polyethylene oxide and copolymers and blends thereof page 20).
Regarding claim 35, pharmaceutical compounds which can be encapsulated released by the instant invention include but are not limited to nucleic acids, proteins and peptides, hormones and steroids, chemotherapeutics, NSALDs, vaccine components, analgesics, antibiotics, anti-depressants, and the like (page
Regarding claims 36-37, the particles having an average diameter of 1 to 50 mm. Ninety percent of the particles have a diameter that is within 1 mm of the average diameter of the particles (page 7). The particles are disclosed to be spheres (page 11).
Kyekyoon, therefore, anticipates the rejected claims.
Allowable Subject Matter
Claims 1-33 are allowed.
As noted in the United Kingdom Search Report dated December 11, 2025, the closest prior art is that of:
David et al. (US 2018/078507) which discloses a method for producing microparticles comprising a liquid core (aqueous) and solid polymeric shell and the produced microparticle for use as a vaccine.
Kyekyoon et al. (WO 02/13786) which discloses another method for producing microparticles comprising a liquid core (aqueous) and solid polymeric shell and the produced microparticle for use as a vaccine.
Damiati et al. ("Microfluidic Synthesis of Indomethacin-Loaded PLGA Microparticles Optimized by Machine Learning", FRONTIERS IN MOLECULAR BIOSCIENCES, vol. 8, 22 September 2021 (2021-09-22)) which discloses microfluidic synthesis of Indomethacin-loaded PLGA microparticles made of a liquid core and a solid polymeric shell. No vaccine is disclosed.
Yu et al.( "Microfluidic formation of core-shell alginate microparticles for protein encapsulation and controlled release", JOURNAL OF COLLOID AND INTERFACE SCIENCE, vol. 539, 1 March 2019 (2019-03-01), pages 497-503) which discloses a microfluidic formation of core-shell alginate microparticles for protein encapsulation and controlled release. The potential as vaccine is discussed in Yu.
However, none of the references disclose the method recited in claim 1. There is no disclosure within any of the cited references of a flow chip.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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