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 .
Specification
The Specification is objected to because of the following informalities: “crossed-linked” should read “cross-linked”. Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: “crossed-linked” should read “cross-linked”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: “list” should read “group”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for some embodiments, does not reasonably provide enablement for all embodiments.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
IgG2b/c antibody response
The breadth of claims 16-18 encompasses a method that employs a vaccine delivery system, the vaccine delivery system comprising a hydrogel, an antigen, and a dinucleotide adjuvant and the method comprising administering the vaccine delivery system to a subject and that subject mounting a IgG2b/c antibody response. The level of skill in the art is high and would include, e.g., Ph.D. level scientists. Embodiments that define the subject as a mouse exclusively are enabled as a vaccine delivery system that induces an IgG2b response, while the subject must be a C57B/6 mouse exclusively to be enabled as a vaccine delivery system that induces an IgG2c response. Embodiments that include other mammals, including humans and other mice strains (for IgG2c), are not enabled as a vaccine delivery system that produces an IgG2b/c response as required by claims 16-18.
The specification provides working examples of the vaccine delivery system inducing an IgG2b/c response in C57B/6 mice, but does not provide any examples or reasonable direction in other mammals, including humans or other mice strains, of an IgG2b/c response (Figs 14, 18-19, 24-26, 43-44, and 57-58). The Office does not doubt that the vaccine delivery system induces an IgG2b/c response in C57B/6 mice, but Dekkers, et al. (MAbs. 2017 Jul;9(5):767-773., hereinafter “Dekkers”) demonstrates that IgG2b antibodies are only produced in mice and IgG2c antibodies are only produced in C57B/6 mice (pg. 767 column 2).
Dekkers provides a review of the state of the art in the antibody isotypes produced by different mice strains and the human IgG subclasses. Only the inbred C57B/6 mice strains produce an IgG2c response while other strains produce an IgG2a response and all mice strains produce an IgG2b response (pg. 767 column 2). Lastly, the only human IgG subclasses are IgG1-4 (pg. 767 column 2). Dekkers demonstrates that an IgG2b antibody response is not reasonable predictive of an IgG2b response in other mammals and neither is an IgG2c response in C57B/6 mice reasonably predictive of the IgG2c response in other mice and mammals as no IgG2b/c antibodies are produced (pg. 767 column 2).
In view of the breadth of the claims, the limited teachings of the specification and working examples regarding other subjects that are not C57B/6 mice, the state of the art, and the low predictability with regard to the ability of other mammals to produce IgG2b/c antibodies, it would require undue experimentation to practice the claimed methods. Amendment of the claims to require the subject to which the vaccine delivery system is administered to be C57B/6 mice or to not require production of IgG2b/c antibodies would overcome the rejection regarding the production of IgG2b/c antibodies.
IgG2c:IgG1 response at >0.3:1The breadth of claim 18 encompasses a method that employs a vaccine delivery system, the vaccine delivery system comprising a hydrogel, an antigen, and a dinucleotide adjuvant and the method comprising administering the vaccine delivery system to a subject and that the vaccine delivery system induces a skewed Th2 response. The level of skill in the art is high and would include, e.g., Ph.D. level scientists. Embodiments that define the subject as a C57B/6 mouse exclusively and require the administration of a vaccine delivery system formulated with an adjuvant that induces a large IgG1 response (e.g., alum) to be enabled as a vaccine delivery system which induces an IgG2c:IgG1 response at >0.3:1 as require by claim 18.
The specification provides working examples of the vaccine delivery system inducing an IgG2c:IgG1 response at >0.3:1 in C57B/6 mice administered a vaccine including alum, but does not provide any examples or reasonable direction in other subjects or with non-alum vaccines, of a skewed Th2 response (¶0145). The Office does not doubt that a vaccine delivery system with alum induces a skewed Th2 response in C57B/6 mice, but Shibuya, et al. (Virol. 2020 Jun 1;94(12):e00323-20., hereinafter “Shibuya”) demonstrates that alum induces a skewed Th2 response while CpG alone induces a skewed Th1 response (Figure 1).
Shibuya provides a review of the state of the art in the antibody responses produced by C57B/6 mice and alum/CpG adjuvant. Only the inbred C57B/6 mice vaccinated with alum produce a skewed Th2 response while the CpG vaccinated mice produced a skewed Th1 response (Figure 1). Shibuya demonstrates that an antibody response to CpG only is not reasonably predicative on the antibody response to alum as individual adjuvants induce individual immune responses (Figure 1).
In view of the breadth of the claims, the limited teachings of the specification and working examples regarding other vaccine delivery systems other than CpG and alum combined, the state of the art, and the low predictability with regard to the ability of other adjuvanted vaccine delivery systems to produce a skewed Th2 response of >0.3:1 IgG2c:IgG1, it would require undue experimentation to practice the claimed methods. Amendment of the claims to require the vaccine delivery system to include alum as an adjuvant along with CpG and the subject to which the vaccine delivery system is administered to be C57B/6 mice would overcome this rejection.
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 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 1-4, 7-9, 12-15, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Satchi-Fainaro, et al. (WO 2020/136,657 A1, hereinafter “Satchi-Fainaro” and further in view of Zhao, et al. (Nanomaterials (Basel). 2015 Dec 3;5(4):2054-2130., hereinafter “Zhao”).
Regarding claim 1, Satchi-Fainaro teaches a vaccine composition comprising a polymeric nanoparticle encapsulating the toll-like receptor (TLR) ligand adjuvant CpG and a disease-associated antigen (Claims 1-3, 4, and 30 and pg. 4 line 30). Satchi-Fainaro does not teach the nanoparticles non-covalently cross-linked with a polymer to form a hydrogel.
However, Zhao teaches nanocomposite hydrogels (pg. 2062). Nanocomposite hydrogels are hydrogels cross-linked with nanoparticles. Hydrogels are a cross-linked hydrophilic polymeric network with a high amount of water created by crosslinking polymer chains. This cross-linking can occur through non-covalent means allowing for movement and shearing (pgs. 2055-2056). Nanocomposite gels incorporate nanoparticles into the hydrogel matrix through covalent or non-covalent means (pg. 2062).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Satchi-Fainaro of a nanoparticle vaccine comprising an antigen and a dinucleotide adjuvant with the teachings of Zhao of a nanocomposite gel. Zhao provides motivation by teaching that combining hydrogels and NPs allows for wider use of NPs by increasing stability and biocompatibility (pg. 2062). One of skill in the art would have had reasonable expectation of success at combining Satchi-Fainaro and Zhao because they both teach nanoparticles.
Regarding claim 2, Satchi-Fainaro teaches a CpG as a TLR ligand adjuvant (Claims 1-3, pg. 4 line 30).
Regarding claims 3-4, Satchi-Fainaro teaches that the adjuvant can be cGAMP, a cyclic dinucleotide (Claims 1-3, pg. 4 line 32).
Regarding claim 7, Zhao teaches a nanocomposite gel where the hydrogel is HPMC (Table 2, pg. 2090).
Regarding claim 8, Satchi-Fainaro teaches that the nanoparticles are polymeric nanoparticles (claims 1-3).
Regarding claim 9, Satchi-Fainaro teaches that the polymeric nanoparticle can be fabricated from PEG-PLA (pg. 4 line 15).
Regarding claim 12, Satchi-Fainaro teaches at least one toll-like receptor ligand adjuvant, and further teaches that both CpG and Resiquimod are TLR ligand adjuvants (claims 1-3 and pg. 4 line 29).
Regarding claim 13, Satchi-Fainaro teaches a method of treating an infectious disease in a subject by administering the polymeric nanoparticles in therapeutically effective amounts and that the adjuvants associated with the NPs induce an immune response (claim 31 and pg. 5 lines 1-5). Zhao teaches that nanocomposite gels can be used for drug delivery (Pg. 2065)
Regarding claims 14 and 15 the vaccine delivery system of claim 1 was rendered prima facie obvious over Satchi-Fainaro and Zhao as discussed above. The type of immune response induced by a certain vaccine is an inherent property of that vaccine. Therefore, as the vaccine delivery system and the method of inducing an immune response with said vaccine delivery system weres rendered obvious, the antibodies induced are also obvious. “[T]he claiming of a[n]… unknown property which is inherently present in the prior art does not necessarily make the claim patentable.” See MPEP 2112. The increased production of IgG andIgG1 antibodies are inherent to the adjuvants used, CpG induces the production of an IgG and IgG1 response as evidenced by Shibuya (Figure 1). Therefore, these properties are inherent to the vaccine delivery system and as the vaccine delivery system has been rendered prima facie obvious, so too are the immune responses induced by the vaccine.
Regarding claim 32, Satchi-Fainaro teaches TLR ligands adjuvants, which are TLR agonists (claims 1-3, pg. 4 lines 24-30).
Regarding claim 33, Zhao teaches a nanocomposite gel with PEG-PLA NPs and an HPMC hydrogel which is shear-thinning (Table 2, pg. 2090)
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Satchi-Fainaro and Zhao as applied to claims 1-4, 7-9, 12-15, and 32-33 above, and further in view of Du, et al. (Nat Rev Microbiol. 2009 Mar;7(3):226-36., hereinafter “Du”).
As discussed above the vaccine delivery system of claim 1 was rendered prima facia obvious over Satchi-Fainaro and Zhao.
Regarding claims 5 and 6, Satchi-Fainaro teaches that the nanoparticle antigen can be a viral antigen, more specifically a SARS viral antigen (pg. 20, line 16). Satchi-Fainaro and Zhao dos not teach that the viral antigen comprises an RBD for a virus. However, Du teaches that the RBD of SARS is a good vaccine target as it is the part of the SARS S protein that binds to the ACE2 receptors, therefore creating binding/neutralizing antibodies against the RBD would prevent viral entry (pg. 230).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Satchi-Fainaro and Zhao to include the viral antigens taught by Du because Du teaches that the RBD of SARS is a good vaccine target as antibodies against the viral antigen would advantageously prevent cell entry (pg. 230). One of skill in the art would have had reasonable expectation of success at combining Satchi-Fainaro, Zhao, and Du because they all teach vaccines.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Satchi-Fainaro and Zhao as applied to claims 1-4, 7-9, 12-15, and 32-33 above, and further in view of Oleszycka, et al. (Curr Opin Immunol. 2014 Jun;28:1-5., hereinafter “Oleszycka”).
As discussed above the vaccine delivery system of claim 1 was rendered prima facie obvious over Satchi-Fainaro and Zhao.
Regarding claims 10 and 11, Satchi-Fainaro teaches a vaccine nanoparticle with multiple adjuvants (Claims 1-3 and 30). Satchi-Fainaro and Zhao do not teach that one of the adjuvants is aluminum hydroxide (alum). However, Oleszycka teaches that alum is the most common adjuvant in non-living vaccines (Abstract). Alum has been successfully used in humans and promotes antibody-mediated protective immunity, though it is a poor inducer of cellular immune response, making it an ideal candidate for part of a multi-adjuvant vaccine (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Satchi-Fainaro and Zhao of a nanocomposite gel vaccine delivery system with viral antigens and multiple adjuvants with the teachings of Oleszycka of the adjuvant alum. Oleszycka provides motivation by teaching that alum has been previously used in licensed human vaccines and promotes antibody mediated-protective immunity (Abstract). One of skill in the art would have had reasonable expectation of success at combining Satchi-Fainaro, Zhao, and Oleszycka because they all teach vaccines.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Satchi-Fainaro and Zhao as applied to claims 1-4, 7-9, 12-15, and 32-33 above, and further in view of Shibuya and Dekker.
As discussed above, claims 1-4, 7-9, 12-15, and 32-were rendered prima facia obvious over Satchi-Fainaro and Zhao.
Regarding claims 16 and 17, Satchi-Fainaro teaches a method of treating an infectious disease in a subject by administering the polymeric nanoparticles in therapeutically effective amounts and that the adjuvants associated with the NPs induce an immune response (claim 31 and pg. 5 lines 1-5). Zhao teaches that nanocomposite gels can be used for drug delivery (Pg. 2065). Satchi-Fainaro and Zhao do not teach that the subjects are C57B/6 mice, which are require for the production of IgG2b/c antibodies (see rejection under 35 U.S.C. § 112(a), above).
However, Shibuya teaches that a C57B/6 mice vaccinated with vaccines containing CpG produce IgG2b/c antibodies (Figure 1). As explained above, C57B/6 mice are the only subject that produce IgG2c antibodies (Dekker, pg. 767 column 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered the vaccine delivery system of Satchi-Fainaro and Zhao to the vaccine animal model taught by Shibuya because Dekker teaches that only C57B/6 mice produce both IgG2b and IgG2c antibodies (pg. 767 column 2), so to produce an immune response with IgG2b/c antibodies a C57B/6 mouse model would be used. One of skill in the art would have had reasonable expectation of success at combining Satchi-Fainaro, Zhao, Dekker, and Shibuya because they all teach vaccines.
Regarding claim 18, Shibuya teaches that alum is required for a skewed Th2 response, as evidenced by more IgG1 produced that IgG2c produced in C57B/6 mice (Figure 1). A vaccine with both alum and CpG would inherently induce an immune response that produces more IgG1 than IgG2c, resulting in the claim limitation of IgG2c:IgG1 being 0.3:1.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 7-9, 13, and 32-33 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 19, and 23-25 of U.S. Patent No. 12,433,959 in view of Shibuya.
Regarding instant claims 1-2, conflicting claims 19 and 23 recite a vaccine delivery system comprising a nanocomposite gel, a TLR agonist, and an antigen. The conflicting claims do not recite that the TLR agonist is CpG or another dinucleotide adjuvant. However, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the conflicting claims with the teachings of Shibuya resulting in a vaccine delivery system comprising a nanocomposite gel, CpG, and an antigen because Shibuya teaches that CpG is a TLR9 agonist (pg. 2, Introduction ¶3). Shibuya provides motivation to modify the conflicting claims by teaching a mouse model using CpG as a vaccine adjuvant and to practice the conflicting claims a specific TLR agonist must be chosen (Figure 1).
Regarding instant claim 7, conflicting claims 19 and 23 recite that the hydrogel comprises HPMC-C12, a derivative of HPMC.
Regarding instant claims 8-9, conflicting claim 19 recites that the nanoparticles are polymeric comprising PEG-PLA.
Regarding instant claim 13, conflicting claims 1 and 5 recite a method of administering a nanocomposite gel, a TLR agonist, and an antigen to induce an immune response. Shibuya recites that CpG is a TLR agonist.
Regarding instant claim 32, conflicting claim 23 recites that the adjuvant is a TLR agonist.
Regarding instant claim 33, conflicting claim 25 recites that the hydrogel is shear-thinning
Claims 1-2 and 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 8, 14, 15, and 17 of copending Application No. 17/925,443 (reference application/conflicting claims). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to a vaccine delivery system consisting of a nanocomposite gel, an adjuvant, and an antigen.
Regarding instant claims 1-2, conflicting claims 1, 7, 14, and 17 recite a vaccine comprising a nanocomposite gel, a CpG adjuvant, and an antigen.
Regarding instant claim 7, conflicting claim 15 recites a hydrogel comprising HPMC.
Regarding instant claims 8-9, conflicting claim 8 recites a polymeric nanoparticle comprising PEG-PLA.
Claim 13 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 20 of copending Application No. 17/925,443 (reference application/conflicting claims) in view of Zhao.
Regarding instant claim 13, conflicting claim 20 recites a method of inducing an immune response by administering a nanoparticle vaccine comprising a TLR agonist and an antigen. Conflicting claim 7 recites that the TLR agonist is CpG. The conflicting claims do not recite that the vaccine includes a hydrogel. However, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the conflicting claims with the teachings of Zhao resulting in a vaccine delivery system comprising a nanocomposite gel, CpG, and an antigen because Zhao teaches nanocomposite gels (pg. 2062). Zhao provides motivation for modifying the conflicting claims by teaching that combining hydrogels and NPs allows for wider use of NPs by increasing stability and biocompatibility (pg. 2062).
Claims 1-2, 7-9, 13, and 32-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 11, 14, 17, and 19 of copending Application No. 19/317,991 in view of Shibuya.
Regarding instant claims 1-2, conflicting claims 11 and 14 recite a vaccine delivery system comprising a nanocomposite gel, a TLR agonist, and an antigen. The conflicting claims do not recite that the TLR agonist is CpG or another dinucleotide adjuvant. However, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the conflicting claims with the teachings of Shibuya resulting in a vaccine delivery system comprising a nanocomposite gel, CpG, and an antigen because Shibuya teaches that CpG is a TLR9 agonist (pg. 2, Introduction ¶3). Shibuya provides motivation to modify the conflicting claims by teaching a mouse model using CpG as a vaccine adjuvant and to practice the conflicting claims a TLR agonist must be chosen (Figure 1).
Regarding instant claim 7, conflicting claims 11 and 17 recite that the hydrogel comprises HPMC-C12, a derivative of HPMC.
Regarding instant claims 8-9, conflicting claim 11 recites that the nanoparticles are polymeric comprising PEG-PLA.
Regarding instant claim 13, conflicting claims 1 and 4 recite a method of administering a vaccine delivery system to subject to activate the immune response, the vaccine delivery system comprising a nanocomposite gel, a TLR agonist, and an antigen. Shibuya teaches that CpG is a TLR agonist.
Regarding instant claim 32, conflicting claim 14 recites that the adjuvant is a TLR agonist.
Regarding instant claim 33, conflicting claim 19 recites the hydrogel is shear-thinning.
Conclusion
NO CLAIMS ARE ALLOWED
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/CASSANDRA SENN GRIZER/ Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672