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 .
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Claims 10-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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, and 19-21 are under current consideration.
Drawings
The drawings are objected to because they contain color yet no petition has been filed as discussed below. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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.
Claim 20 is 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 20 recites that the heparosan polymer is hyaluronan or chondroitin sulfate, but heparosan and hyaluronan and chondroitin sulfate are distinct glycosaminoglycan molecules having different structures, such that a heparosan polymer is not hyaluronan or chondroitin sulfate, and thus the scope of the claim is illogical/unclear and indefinite. Since heparosan is not hyaluronan or chondroitin sulfate, and thus the claim is illogical, a prior art rejection would be improper given the great deal of confusion, and is not made herein per MPEP 2173.06(II).
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, and 8-9 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).
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) wherein the therapeutic agent is a polynucleotide 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 at least one heparosan polymer 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.
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.
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) wherein the therapeutic agent is a polynucleotide 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 at least one heparosan polymer 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 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 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).
Regarding claims 6 and 21 (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) wherein the therapeutic agent is a polynucleotide 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 at least one heparosan polymer 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 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.
Conclusion
No claims are allowed.
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.
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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