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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-2, 5, 8, 19, 21, 35-38, 41-42, 46-47 and 54 in the reply filed on 12 January 2026 is acknowledged.
Claims 56-57 and 66-69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12 January 2026.
Applicant has also elected the species of a peptide antigen. No claims are withdrawn due to the species election.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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 1-2, 5, 8, 19, 21, 35-38, 41-42, 46-47, and 54 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 that the antigen is covalently bound to the nanoparticle. This limitation is indefinite for multiple reasons, as set forth below.
A) It is Unclear if the Specification Redefined the Phrase “Covalently Bound” in a Manner Different from its Ordinary Meaning in the Art: As an initial matter, the examiner takes the position that the phrase “covalently bound” has a well-known meaning in the art. Nevertheless, the examiner also notes the following. First, an applicant is entitled to be their own lexicographer and may rebut the presumption that claim terms are to be given their ordinary and customary meaning by clearly setting forth a definition of the term that is different from its ordinary and customary meaning(s) in the specification at the relevant time. See MPEP 2111.01(IV)(A). Secondly, a claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP 2173.03, second paragraph.
In this case, it is unclear if applicant has redefined the term “covalently bound” in a manner different from its ordinary and customary meaning. In support of this position, the examiner notes the instant specification on page 46, Example 4, paragraph 0171, relevant text reproduced in part below.
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The skilled artisan would not have expected that mixing thiolated SARS-CoV-2 spike protein with mesoporous silica nanoparticles (MSNP) derivatized with polyethylene glycol (PEG) and subsequently polyethyleneimine (PEI) would have resulted in a covalent bond forming between the sulfur of the thiolated spike protein and the amine group of the PEI, according to the normal definition of the phrase “covalently bound.” As such, it is unclear to the examiner if the above-reproduced text represents the applicant having acted as their own lexicographer and redefined the phrase “covalently bound” in the manner set forth in MPEP 2111.01(IV)(A).
For the purposes of examination under prior art, the examiner will examine the phrase “covalently bound” in accordance with its ordinary and customary meaning in the art.
B) If Antigen Comprises Multiple Proteins, Do All Proteins Need to be Covalently Bound to Meet Claim Requirements: However, claims 35-36, which depend upon claim 1, recite that the antigen is a virus, bacterium, protozoan, or fungus. The skilled artisan would have understood a virus, bacterium, protozoan, or fungus to have comprise multiple proteins that are part of the same virus or living organism but are not covalently bound together. For example, as best understood by the examiner, the SARS-CoV-2 virus comprises 29 proteins, four of which are structural. Bacteria, protozoans, and fungi comprise far more proteins than 29. As such, it is unclear if a case wherein less than all of the proteins of the virus, bacterium, protozoan, or fungus are covalently bound to the nanoparticle is sufficient to meet the claim requirements, or if the claim requires all of the proteins of the virus, bacterium, protozoan, or fungus to be bound to the nanoparticle.
For the purposes of examination under prior art, the examiner will examine the claims as if they are drawn to protein/peptide/subunit vaccines rather than either inactivated whole-virus or whole-organism vaccines or live attenuated virus/organism vaccines, and will examine the claim as if the claim requires that of the proteins/peptides be covalently bound to the nanoparticle. Claim 36 will be understood to require an antigen that is a protein or peptide from, or a subunit of Dengue, Plasmodium, or Mycobacterium, and wherein an immune reaction against said vaccine would have been protective against a disease caused by Dengue, Plasmodium (i.e. malaria), or Mycobacterium.
Multiple Numerical Ranges in Claims – No Indefiniteness
Claim 2 recites that the nanoparticle has a hydrodynamic diameter of about 30 nm to about 200 nm, or about 100 nm. The inclusion of multiple numerical ranges in the claims does not render the claims indefinite because the multiple numerical ranges are clearly presented in the alternative. MPEP 2173.05(h)(I), last paragraph in section, discusses a case in which the Markush group, "selected from the group consisting of amino, halogen, nitro, chloro and alkyl" should be acceptable even though "halogen" is generic to "chloro." Similarly, the Markush group of selected between having a hydrodynamic diameter of about 30 nm to about 200 nm, or a hydrodynamic diameter of about 100 nm is acceptable even though “about 30 nm to about 200 nm” is generic to “about 100 nm.”
Relevant Prior Art - No Rejection
The examiner has reviewed relevant prior art over which the instant claims have not been rejected.
Valiante Reference and mRNA Vaccines: In the previously presented restriction requirement mailed on 12 August 2025, the examiner identified Valiante et al. (US 2018/0318409 A1) as prior art; see the restriction requirement on page 2. In view of the claim amendments, the examiner has not rejected the instant claims over Valiante. This is because Valiante is drawn to mRNA vaccines. Said vaccines comprise mRNA which, during normal operation, enters a cell and encodes a protein, wherein the protein that is encoded is the antigen. As such, the mRNA of Valiante is an antigen-producing agent rather than an antigen. As applicant amended claim 1 to remove antigen-producing agents from the claim, Valiante is no longer prior art that is applicable to reject the instantly claims. The rationale provided by the examiner regarding Valiante explains the examiner’s decision not to reject the instant claims over prior art drawn to mRNA vaccines.
Claim Rejections - 35 USC § 103 – Obviousness
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.
Claim(s) 1-2, 19, 35, 37-38 and 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brinker et al. (US 2016/0287717 A1) in view of Mody et al. (Nanoscale, Vol. 5, 2013, pages 5167-5179).
Brinker et al. (hereafter referred to as Brinker) is drawn to mesoporous silica nanoparticles, as of Brinker, title and abstract. Brinker teaches the following as of paragraph 0077, which has been reproduced in part below with annotation by the examiner.
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The abbreviation “MSNP” refers to mesoporous silica. As such, Brinker appears to teach covalent bonding of an antigen to the surface of a mesoporous silica nanoparticle. Elsewhere in the reference, Brinker teaches polyethyleneimine, which is abbreviated as “PEI,” as of numerous locations in the reference including but not limited to paragraph 0124. Brinker also teaches a particle diameter of between about 25 nm and 300 nm, as of Brinker, paragraph 0009.
Brinker is understood to be deficient because Brinker is understood to fail to teach that the antigen is of an infectious agent.
Mody et al. (hereafter referred to as Mody) is drawn to mesoporous silica nanoparticles as antigen carriers, as of Mody, page 5167, title and abstract. Mody teaches the following, as of page 5170, figure 1, reproduced below.
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Also see Mody, page 5173, figure 3, reproduced in part below.
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Mody teaches vaccination against pathogens, as of page 5167, right column, and provides an example in which a vaccine against bovine diarrhea virus is used, as of Mody, page 5169, left column, first paragraph below table. Additionally, the examples as of Mody, page 5169, Table teach various antigens which include a HIV antigen in one embodiment and a bacterial recombinant protein in another embodiment, both of which would appear to be antigens of infectious diseases.
Mody appears to differ from the claimed invention because Mody appears to show the antigen loaded into the interior of the particles rather than covalently bound to the silica particle.
It would have been prima facie obvious for one of ordinary skill in the art to have used antigens against infectious diseases, as taught by Mody, as the antigens in the composition of Brinker. Brinker is drawn to a composition which comprises antigens; however, Brinker is silent as to the immune response that is generated against the antigens taught by Brinker. Mody teaches antigens against various pathogens, including HIV and bacteria. As such, the skilled artisan would have been motivated to have formulated the composition of Brinker such that the antigen of Brinker would have been against an infectious pathogen for predictable vaccination against said infectious pathogen with a reasonable expectation of success.
As to claim 1, the claim requires an immunogenic construct. Mody teaches a vaccine, as of page 5167, title, which is immunogenic. Brinker teaches an antigen on paragraph 0077; the skilled artisan would have understood an antigen to have been immunogenic.
As to claim 1, the claim requires a nanoparticle platform comprising a mesoporous silica nanoparticle. This is taught by both Mody and Brinker.
As to claim 1, the claim requires polyethyleneimine (PEI) in an amount of at least 10% by weight. Brinker teaches the following in paragraph 0008, which is reproduced in part below.
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As best understood by the examiner, Brinker appears to suggest the inclusion of PEI-silane in amounts up to 25%, as of Brinker, paragraph 0008. These amounts overlap with the requirement of at least 10% PEI. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I). Additionally, what is described in paragraph 0008 of Brinker would have resulted in the PEI being present on the surface of the particle.
As to claim 1, the claim requires an antigen of an infectious disease. Brinker teaches an antigen in paragraph 0077, but does not specify that the antigen is of an infectious disease. However, Mody teaches various antigens, which are of infectious diseases. The teachings of Brinker indicate that the antigen is covalently bound to the nanoparticle.
As to claim 1, the claim requires that the hydrodynamic size of the immunogenic construct is no more than 1 micron. Brinker teaches particle sizes of about 25-300 nm in paragraph 0009. The skilled artisan would have understood this to have been in the claimed size range.
As to claim 2, Brinker appears to tach PEI in the presence of crosslinkers as of paragraph 0130; the skilled artisan would have expected that this would have resulted in crosslinked PEI.
As to claim 2, Brinker teaches PEG as of multiple locations in the reference including paragraphs 0031-0033; this would have read on the required stabilizer.
As to claim 2, Mody teaches adjuvants (in addition to the silica particle of Mody) such as alum, as of Mody, page 5168, left column, top paragraph.
As to claim 2, Mody teaches particles sized from 50-200 nm, as of Mody, page 5169, right column, last full paragraph.
As to claim 19, Brinker teaches PEG, as of multiple locations in the reference, including but not limited to paragraphs 0031-0034 and 0075. Brinker teaches PEG molecular weights of about 1000-2500 in paragraph 0075. This reads on the required molecular weights of about 1 kDa to about 2.5 kDa, which is within the claim scope.
As to claim 35, Mody teaches antigens against both HIV, which is a virus, bovine viral diarrhea virus, and a bacterial recombinant protein, as of Mody, page 5169, left column, Table 1 and paragraph below table 1.
As to claim 37, Brinker teaches a particular type of siRNA as of paragraph 0093, end of paragraph.
As to claim 38, this claim is rejected for essentially the same reason that claim 37 is rejected.
As to claim 54, Brinker teaches a composition, and teaches a pharmaceutically acceptable excipient in paragraph 0109.
Claim(s) 5, 8, 21, 35-36, and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brinker et al. (US 2016/0287717 A1) in view of Mody et al. (Nanoscale, Vol. 5, 2013, pages 5167-5179), the combination further in view of Bratzler et al. (US 2011/0293723 A1).
Brinker is drawn to mesoporous silica nanoparticles comprising an antigen and polyethyleneimine. Mody is drawn to mesoporous silica nanoparticles comprising an antigen for a viral or bacterial vaccine. See the rejection above over Brinker in view of Mody.
Neither Brinker nor Mody teach the required adjuvant.
Bratzler et al. (hereafter referred to as Bratzler) is drawn to synthetic nanocarriers for vaccines, as of Bratzler, title and abstract. Bratzler teaches various adjuvants in paragraph 0007 which include CpG DNA, bacterial lipopolysaccharide (i.e. LPS), imiquimod, resiquimod, and other adjuvants in paragraph 0007.
Bratzler does not teach a mesoporous silica nanoparticle.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the adjuvant of Bratzler with the composition of Brinker in view of Mody. The combination of Brinker in view of Mody is drawn to a vaccine composition. Bratzler is also drawn to a vaccine composition, and teaches the use of various ingredients such as CpG DNA, bacterial lipopolysaccharide, imiquimod, resiquimod as adjuvants to stimulate the immune system. As such, the skilled artisan would have been motivated to have combined the adjuvants of Bratzler with the composition of Brinker in view of Mody in order to have predictably enhanced the immune response to the composition of Bratzler in view of Mody in order to have predictably resulted in a greater immune response and more effective vaccine with a reasonable expectation of success.
As to claim 5, Bratzler teaches various adjuvants in paragraph 0007 which include CpG DNA, bacterial lipopolysaccharide (i.e. LPS), imiquimod, resiquimod, and other adjuvants in paragraph 0007.
As to claim 8, Bratzler teaches 8.5% resiquimod in paragraph 0152.
As to claim 21, Bratzler teaches the following, as of paragraph 0143, relevant text reproduced below.
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As best understood by the examiner, the above-reproduced text would have resulted in peptide antigen being covalently bound to PEG, wherein PEG reads on the required stabilizer. This covalent bonding would be via a 1,2,3-triazole group, which would have formed by linking the azide attached to the PEG with the alkyene in the acetylene of the “X” group to have formed a 1,2,3-triazole covalent linkage by alkyne-azide cycloaddition, also known as the Huisgen reaction or as “click chemistry.”
As to claims 35-36, Bratzler teaches a vaccine against Dengue virus, as of Bratzler, paragraph 0013 and page 15, Table 1.
As to claim 46, Bratzler teaches a targeting moiety in paragraph 0071.
Claim(s) 5, 8, 37-38, and 41-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brinker et al. (US 2016/0287717 A1) in view of Mody et al. (Nanoscale, Vol. 5, 2013, pages 5167-5179), the combination further in view of Luo et al. (Biomaterials Vol. 38, 2015, pages 50-60 and 5 pages of supplementary data).
Claim(s) 5, 8, 37-38, and 41-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brinker et al. (US 2016/0287717 A1) in view of Mody et al. (Nanoscale, Vol. 5, 2013, pages 5167-5179), and Bratzler et al. (US 2011/0293723 A1), the combination further in view of Luo et al. (Biomaterials Vol. 38, 2015, pages 50-60 and 5 pages of supplementary data).
Brinker is drawn to mesoporous silica nanoparticles comprising an antigen and polyethyleneimine. Mody is drawn to mesoporous silica nanoparticles comprising an antigen for a viral or bacterial vaccine. See the rejection above over Brinker in view of Mody. Bratzler teaches a targeting moiety generically in paragraph 0071. See the rejection above over the combination of Brinker in view of Mody and Bratzler.
None of the above references teach siRNA which inhibits STAT3.
Luo et al. (hereafter referred to as Luo) is drawn to a vaccine comprising poly(I:C) and STAT3 siRNA along with ovalbumin as a model antigen, as of Luo, page 50, title and abstract, as well as page 53, figure 1A, reproduced below.
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Inclusion of this siRNA appears to result in a greater immune response regarding T-cell activation, as of at least Luo, page 59, figures 9A and 9B, reproduced below.
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Luo differs from the claimed invention because Luo does not teach the required mesoporous silica.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the poly(I:C) and siRNA of Luo with the composition of Brinker in view of Mody, optionally as modified by Bratzler. Brinker, Mody, and Bratzler are drawn to a composition comprising an antigen and a mesoporous silica particle (in the case of Brinker and Mody), which is usable as a vaccine. Luo teaches that STAT3 siRNA enhances immune response to a vaccine. As such, the skilled artisan would have been motivated to have combined the siRNA of Luo with the vaccine made by the combination of Brinker, Mody, and optionally Bratzler for predictable enhancement of vaccine efficacy with a reasonable expectation of success.
The examiner notes here that Luo is drawn to a cancer vaccine, whereas Brinker, Mody, Bratzler, and the instant claims are drawn to an infectious disease vaccine. Nevertheless, the skilled artisan would have been motivated to have used the siRNA of Luo for an infectious disease vaccine. This is because, as best understood by the examiner, infectious disease vaccines and cancer vaccines operate by similar mechanisms in which the vaccine activates the innate immune system, which subsequently results in the antigens being exposed to antigen presenting cells and subsequently results in antibody formation against the antigen and T-cell recognition of the antigen. Infectious disease and cancer vaccines differ significantly because the evoked immune response against the different types of antigens treats or prevents different diseases. Nevertheless, the skilled artisan would have expected that the process by which the evoked immune response would have been sufficiently similar in the case of infectious disease vaccines and cancer vaccines that there would have been a reasonable expectation that a modification that was found to have been successful for cancer vaccines (e.g. administering STAT3 siRNA) would also have been successful for infectious disease vaccines.
As to claim 5, Luo teaches poly(I:C) as of page 50, title.
As to claim 8, Luo teaches the following, as of the first page of the supplementary material, relevant table reproduced below.
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The percentage of poly(I:C) appears to be the following:
1
10
+
2
+
1
+
0.67
=
a
b
o
u
t
7.3
%
This amount is within the claim scope.
As to claim 37, the siRNA of Luo reads on the required at least one oligonucleotide.
As to claim 38, the amount of siRNA of Luo appears to be the following, as of Table S1
0.67
10
+
2
+
1
+
0.67
=
a
b
o
u
t
4.9
%
This amount appears to be within the claim scope.
As to claims 41-42, the STAT3 siRNA of Luo has been described as an immunosuppressive gene silencer, as of Luo, page 50, end of abstract.
Claim(s) 46-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brinker et al. (US 2016/0287717 A1) in view of Mody et al. (Nanoscale, Vol. 5, 2013, pages 5167-5179), and Bratzler et al. (US 2011/0293723 A1), the combination further in view of Bandyopadhyay et al. (Biomaterials, Vol. 32, 2011, pages 3094-3105).
Brinker is drawn to mesoporous silica nanoparticles comprising an antigen and polyethyleneimine. Mody is drawn to mesoporous silica nanoparticles comprising an antigen for a viral or bacterial vaccine. Bratzler teaches a targeting moiety generically in paragraph 0071. See the rejection above over the combination of Brinker in view of Mody and Bratzler.
None of the above references teach that the targeting ligand targets dendritic cells.
Bandyopadhyay et al. (hereafter referred to as Bandyopadhyay et al.) is drawn to dendritic cell targeting antigen delivery systems for enhancing vaccine delivery, as of Bandyopadhyay, page 3094, title and abstract. Bandyopadhyay teaches the following formulation, as of page 3096, figure 1, reproduced below.
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The DEC-205 appears to target dendritic cells by targeting the lectin receptor on said cells, as of Bandyopadhyay, page 3094, abstract.
Bandyopadhyay differs from the claimed invention because Bandyopadhyay teaches a PLGA particle rather than a silica particle, and teaches that the antigen is encapsulated rather than covalently bound to the outside of the particle.
It would have been prima facie obvious for one of ordinary skill in the art to have used targeting ligands to target dendritic cells, as of Bandyopadhyay, in the vaccine of Brinker in view of Mody and Bratzler. The vaccine of Brinker, Mody, and Bratzler may contain targeting ligands, as taught by Bratzler. However, Bratzler is silent as to what is targeted by the targeting ligands of Bratzler. Bandyopadhyay teaches that dendritic cell targeting ligands enhance vaccine efficacy. As such, the skilled artisan would have been motivated to have modified the vaccine of Brinker, Mody, and Bratzler to have had targeting ligands to target dendritic cells, as of Bandyopadhyay, in order to have predictably enhanced vaccine efficacy with a reasonable expectation of success.
As to claims 46-47, the compound of Bandyopadhyay targets a dendritic cell.
Claim(s) 1-2, 19, 35, 37-38 and 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brinker et al. (US 2016/0287717 A1) in view of Mody et al. (Nanoscale, Vol. 5, 2013, pages 5167-5179), the combination further in view of Yantasee et al. (US 2017/0173169 A1).
Claim(s) 5, 8, 21, 35-36, and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brinker et al. (US 2016/0287717 A1) in view of Mody et al. (Nanoscale, Vol. 5, 2013, pages 5167-5179) and Yantasee et al. (US 2017/0173169 A1), the combination further in view of Bratzler et al. (US 2011/0293723 A1).
Claim(s) 5, 8, 37-38, and 41-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brinker et al. (US 2016/0287717 A1) in view of Mody et al. (Nanoscale, Vol. 5, 2013, pages 5167-5179) and Yantasee et al. (US 2017/0173169 A1), the combination further in view of Luo et al. (Biomaterials Vol. 38, 2015, pages 50-60 and 5 pages of supplementary data).
Claim(s) 5, 8, 37-38, and 41-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brinker et al. (US 2016/0287717 A1) in view of Mody et al. (Nanoscale, Vol. 5, 2013, pages 5167-5179), Yantasee et al. (US 2017/0173169 A1), and Bratzler et al. (US 2011/0293723 A1), the combination further in view of Luo et al. (Biomaterials Vol. 38, 2015, pages 50-60 and 5 pages of supplementary data).
Claim(s) 46-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brinker et al. (US 2016/0287717 A1) in view of Mody et al. (Nanoscale, Vol. 5, 2013, pages 5167-5179), Yantasee et al. (US 2017/0173169 A1), and Bratzler et al. (US 2011/0293723 A1), the combination further in view of Bandyopadhyay et al. (Biomaterials, Vol. 32, 2011, pages 3094-3105).
Brinker is drawn to a silica nanoparticle with an antigen attached thereto. Mody is drawn to a silica nanoparticle for delivery of vaccines. Bratzler, Luo, and Bandyopadhyay are drawn to various adjuvants, targeting moieties, and siRNAs required by the dependent claims. See the rejection above.
For the purposes of this rejection, the examiner understands that Brinker is deficient because it is unclear as to whether the polyethyleneimine (PEI) taught by Brinker is crosslinked.
Yantasee et al. (hereafter referred to as Yantasee) is drawn to nanocarriers comprising a cationic polymer, as of Yantasee, title and abstract. Yantasee teaches the use of PEI to deliver siRNA, as of Yantasee, figure 1B, reproduced below.
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Yantasee teaches crosslinked polyethyleneimine, as of at least Yantasee, paragraph 0072, as well as multiple other locations in the reference. Yantasee teaches that crosslinked PEI is useful for carrying siRNA, as of at least Yantasee, paragraph 0176.
Yantasee does not teach an infectious disease antigen.
It would have been prima facie obvious for one of ordinary skill in the art to have crosslinked the PEI of Brinker in the manner taught by Yantasee. Brinker is drawn to PEI for improved delivery, as of Brinker, paragraph 0006. Yantasee teaches that PEI may be crosslinked in a nanoparticle used to deliver active agents. As such, the skilled artisan would have been motivated to have crosslinked the PEI of Brinker in the manner taught by Yantasee for predictable delivery of the active agents of Brinker with a reasonable expectation of success.
Relevant Art – No Rejections
As relevant art, the examiner cites Yantasee et al. (US 11,235,058). The examiner considered this reference both with respect to prior art rejections and double patenting rejections, but decided not to reject the instant claims over this reference. The examiner presents the following rationale in support of this position.
Claim 1 of the ‘058 application recites the following:
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This claim appears to recite all of the required ingredients of the instant claims except for the infectious disease antigen covalently bonded to the nanoparticle. In fact, this claim appears to exclude certain antigens. Other claims of the ‘058 patent appear to be drawn to a method of treatment of a hyperproliferative disease such as cancer; see e.g. claim 9 of the ‘058 patent.
As such, the ‘058 patent appears to be drawn to cancer treatment and does not appear to include an antigen during its use. As such, the skilled artisan would not have been motivated to have modified the composition of the ‘058 patent to have included an antigen for an infectious disease. In view of this, the examiner has not rejected the instant claims on the grounds of non-statutory double patenting over the claims of the ‘058 patent.
Additionally, the ‘058 patent appears to have an earlier effective filing date than the instant application. Nevertheless, the ‘058 patent does not appear to teach vaccinating against an infectious disease and appears to be drawn to eliciting an anti-cancer immune response. As such, the skilled artisan would not have been motivated to have modified the subject matter of the ‘058 patent to have included an infectious disease antigen, let alone such an antigen covalently bound to the nanoparticle. As such, no prior art rejection over the ‘058 patent has been written by the examiner.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612