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
Applicant’s response dated 28 April 2026 to the previous Office action dated 28 January 2026 is acknowledged. Pursuant to amendments therein, claims 1-3, 5-19, and 21-23 are pending in the application.
The drawing objection made in the previous Office action is withdrawn in view of applicant’s submission of acceptable replacement sheets.
The rejection under 35 U.S.C. 112 made in the previous Office action is withdrawn in view of applicant’s cancelation of claim 20, but a new rejection under 35 U.S.C. 112 is made herein in view of applicant’s claim amendments.
The rejection under 35 U.S.C. 102 made in the previous Office action is withdrawn in view of applicant’s claim amendments, but a new (modified) rejection under 35 U.S.C. 102 is made herein in view of applicant’s claim amendments.
The rejections under 35 U.S.C. 103 made in the previous Office action are withdrawn in view of applicant’s claim amendments, but new (modified) rejections under 35 U.S.C. 103 are made herein in view of applicant’s claim amendments.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-3, 5-9, 19-21) in the reply filed on 22 December 2025 is acknowledged.
Claims 10-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 December 2025.
Claims 1-3, 5-9, 19, and 21-23 are under current consideration.
Drawings
The drawings were received on 28 April 2026. These drawings are acceptable.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9, 19, and 21-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites both a product and process in the same claim, in that a composition is claimed yet the claim also recites a method step in that the heparosan chains interact with an immune cell, and thus the claim is indefinite per MPEP 2173.05(p)(II). Claim 1 does not merely recite a capability of the heparosan chains and/or particle, which would be acceptable. Claims 2-9, 19, and 21-22 are rejected as depending upon claim 1 without remedying such deficiency.
Claim 22 recites both a product and process in the same claim, in that a composition is claimed yet the claim also recites a method step in that the immunogenic molecule enters an immune cell, and thus the claim is indefinite per MPEP 2173.05(p)(II). Claim 22 does not merely recite a capability of the immunogenic molecule, which would be acceptable.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5, 8-9, and 23 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by DeAngelis (US 2015/0140073 A1; published 21 May 2015; of record).
Regarding claim 1, DeAngelis discloses a drug delivery composition comprising a multimolecular assembly with at least one heparosan polymer attached to a surface of the assembly and at least one therapeutic agent bound in the multimolecular assembly (abstract; claim 1) such as a plurality of heparosan polymers (claim 14) wherein the therapeutic agent is a polynucleotide, antibody, and/or vaccine antigen (claim 2) wherein the multimolecular assembly is a liposome (claims 7, 8) wherein the liposomes are coated with the heparosan (Example 4), which reads on the claimed composition comprising a particle (e.g., liposome) comprising multiple heparosan chains coated to its surface (e.g., attached to a surface, coated) to form a surface-coated particle and at least one immunogenic molecule (e.g., vaccine antigen) covalently or non-covalently linked (e.g., bound) to the surface-coated particle.
Further regarding claim 1, DeAngelis discloses that the heparosan can couple to biologic targets (paragraph [0119]) wherein targeting ligands can be antibodies or antigens that target nearly any cell type in the body to deliver drugs (paragraph [0083]), which reads on the claimed heparosan chains interacting with an immune cell to promote uptake of the surface-coated particle by the immune cell, given that the therapeutic agent can be an antibody and/or antigen (i.e., an immunogenic molecule, which would interact with an immune cell to promote uptake of the surface-coated particle by the immune cell) as discussed above.
Regarding claim 2, DeAngelis discloses that liposomes refers to nanoparticles (paragraph [0003]), which reads on the claimed particle being a nanoparticle.
Regarding claim 3, DeAngelis discloses 28 kDa heparosan (Example 4), which reads on the claimed heparosan polymer having a mass in the range of from about 600 Da to about 100 kDa.
Regarding claim 5, DeAngelis discloses that the heparosan polymer is a linear chain (claim 16), which reads on the claimed heparosan polymer being a linear chain heparosan polymer.
Regarding claim 8, DeAngelis discloses that the therapeutic agent is a vaccine antigen (claim 2), which reads on the claimed composition being a vaccine composition.
Regarding claim 9, DeAngelis discloses that the multimolecular assembly is a liposome (claims 7, 8), which reads on the claimed particle being a liposome.
Regarding claim 23, see above regarding claim 1, which reads on the claimed composition comprising a particle comprising multiple heparosan chains coated on a surface of the particle and at least on immunogenic molecule or immunogen-encoding molecule covalently or non-covalently associated with the particle wherein the multiple heparosan chains promote selective uptake of the particle by antigen-presenting immune cells or macrophages.
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.
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.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeAngelis.
Regarding claim 19 (as it refers to claim 1), DeAngelis discloses a drug delivery composition comprising a multimolecular assembly with at least one heparosan polymer attached to a surface of the assembly and at least one therapeutic agent bound in the multimolecular assembly (abstract; claim 1) such as a plurality of heparosan polymers (claim 14) wherein the therapeutic agent is a polynucleotide, antibody, and/or vaccine antigen (claim 2) wherein the multimolecular assembly is a liposome (claims 7, 8) wherein the liposomes are coated with the heparosan (Example 4), which reads on the claimed composition comprising a particle (e.g., liposome) comprising multiple heparosan chains coated to its surface (e.g., attached to a surface, coated) to form a surface-coated particle and at least one immunogenic molecule (e.g., vaccine antigen) covalently or non-covalently linked (e.g., bound) to the surface-coated particle. DeAngelis also discloses that the heparosan can couple to biologic targets (paragraph [0119]) wherein targeting ligands can be antibodies or antigens that target nearly any cell type in the body to deliver drugs (paragraph [0083]), which reads on the claimed heparosan chains interacting with an immune cell to promote uptake of the surface-coated particle by the immune cell, given that the therapeutic agent can be an antibody and/or antigen (i.e., an immunogenic molecule, which would interact with an immune cell to promote uptake of the surface-coated particle by the immune cell) as discussed above.
Further regarding claim 19, DeAngelis discloses that the percentage of drug delivery composition “decorated” with heparosan in the compositions and preparations may be varied (paragraph [0105]). Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of DeAngelis and to optimize drug delivery by varying the percentage of the drug delivery composition “decorated” with heparosan in the compositions and preparations thereof through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success. Such varying necessarily varies the surface coating density of the heparosan, resulting in prima facie obviousness via routine optimization per MPEP 2144.05(II).
Claim(s) 6-7 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeAngelis in view of de Fougerolles et al. (US 2013/0156849 A1; published 20 June 2013; of record).
Regarding claims 6 and 21-22 (as they refer to claim 1), DeAngelis discloses a drug delivery composition comprising a multimolecular assembly with at least one heparosan polymer attached to a surface of the assembly and at least one therapeutic agent bound in the multimolecular assembly (abstract; claim 1) such as a plurality of heparosan polymers (claim 14) wherein the therapeutic agent is a polynucleotide, antibody, and/or vaccine antigen (claim 2) wherein the multimolecular assembly is a liposome (claims 7, 8) wherein the liposomes are coated with the heparosan (Example 4), which reads on the claimed composition comprising a particle (e.g., liposome) comprising multiple heparosan chains coated to its surface (e.g., attached to a surface, coated) to form a surface-coated particle and at least one immunogenic molecule (e.g., vaccine antigen) covalently or non-covalently linked (e.g., bound) to the surface-coated particle. DeAngelis also discloses that the heparosan can couple to biologic targets (paragraph [0119]) wherein targeting ligands can be antibodies or antigens that target nearly any cell type in the body to deliver drugs (paragraph [0083]), which reads on the claimed heparosan chains interacting with an immune cell to promote uptake of the surface-coated particle by the immune cell, given that the therapeutic agent can be an antibody and/or antigen (i.e., an immunogenic molecule, which would interact with an immune cell to promote uptake of the surface-coated particle by the immune cell) as discussed above.
DeAngelis does not disclose that the polynucleotide encodes an immunogenic peptide or protein as in claim 6.
de Fougerolles et al. discloses production of a pharmacologic effect in a primate comprising contacting said primate with a composition comprising RNA encoding a polypeptide (claim 55) wherein the formulation is nanoparticles or liposomes (claim 57) wherein the pharmacologic effect is treatment or prevention (claims 61-63) wherein the RNA encodes immunogenic peptides/polypeptides (paragraph [0340]) useful as a vaccine (paragraph [0341]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of DeAngelis and de Fougerolles et al. by using RNA that encodes immunogenic peptides/polypeptides for use as a vaccine for treatment or prevention as in de Fougerolles et al. for the polynucleotide in the composition and method of DeAngelis as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to use a polynucleotide therein that was known to result in effective use as a vaccine for treatment or prevention as suggested by de Fougerolles et al. given that DeAngelis suggests using a polynucleotide therapeutic agent and a vaccine.
Regarding claim 7, DeAngelis discloses that polynucleotides include ribose nucleotides (paragraph [0044]), which reads on the claimed nucleic acid being ribonucleic acid.
Further regarding claim 21, DeAngelis discloses that the heparosan is quasi-monodisperse (Table 1 paragraph [0076]), which reads on the claimed heparosan polymer being a quasi-monodispersed heparosan polysaccharide.
Further regarding claim 21, DeAngelis discloses that polynucleotides include ribose nucleotides (paragraph [0044]), which reads on the claimed immunogenic molecule being ribonucleic acid.
Further regarding claim 21, DeAngelis discloses that the delivery system may be liposomes or nanoparticles (paragraph [0003], [0009], [0040], [0041], [0109]), which reads on the claimed particle being a nanoparticle.
DeAngelis does not disclose the nanoparticle being gold as in claim 21.
de Fougerolles et al. discloses production of a pharmacologic effect in a primate comprising contacting said primate with a composition comprising RNA encoding a polypeptide (claim 55) wherein the formulation is nanoparticles or liposomes (claim 57) wherein the pharmacologic effect is treatment or prevention (claims 61-63) wherein the RNA encodes immunogenic peptides/polypeptides (paragraph [0340]) useful as a vaccine (paragraph [0341]) wherein the RNA may be conjugated with gold nanoparticles (paragraph [0457]).
It also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of DeAngelis and de Fougerolles et al. by using gold nanoparticle as in de Fougerolles et al. as the nanoparticle in the composition and method of DeAngelis as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to use a nanoparticle therein that was known to result in effective use as a vaccine for treatment or prevention as suggested by de Fougerolles et al. given that DeAngelis suggests using a nanoparticle.
Further regarding claim 22, see above regarding claim 21, as well as claims 1 and 9, which reads on the claimed immunogenic molecule being present in the gold surface-coated particle such that the immunogenic molecule enters an immune cell.
Response to Arguments
Applicant's arguments filed 28 April 2026 have been fully considered but they are not persuasive with respect to the current prior art rejections.
Applicant argues that DeAngelis discloses heparosan functioning as a stealth coating to evade immune recognition rather than promoting uptake by immune cells, which is unexpected (remarks pages 7-11). In response, DeAngelis discloses that the heparosan can couple to biologic targets (paragraph [0119]) wherein targeting ligands can be antibodies or antigens that target nearly any cell type in the body to deliver drugs (paragraph [0083]), which reads on the claimed heparosan chains interacting with an immune cell to promote uptake of the surface-coated particle by the immune cell, given that the therapeutic agent can be an antibody and/or antigen (i.e., an immunogenic molecule, which would interact with an immune cell to promote uptake of the surface-coated particle by the immune cell) as discussed in the rejections.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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