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 .
Detailed Action
Restriction/Election
Applicant’s election without traverse of group I, claims 1-16 in the reply filed on 07/07/26 is acknowledged. Applicant’s election of Species 1: Poly(lactic-co-glycolic acid) (PLGA) as the elected biodegradable polymer. Species 2: Hydroxypropyl-β-cyclodextrin as the elected cyclodextrin. Species 3: Squalene as the elected specific adjuvant is also acknowledged.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 07/07/26.
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.
Claims 1-7, 9-10, 12-13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over DOLEN, Y. et al. (Co-delivery of PLGA encapsulated invariant NKT cell agonist with antigenic protein induce strong T cell-mediated antitumor immune responses. Oncoimmunology, 12 August 2015, vol. 5, no. 1, articles no. e1068493, pp. 1-10, doi: 10.1080/2162402X.2015.1068493, presented in IDS).
Dolen et al. indicates that: nanoparticles (NP(α-GC); composite) comprising α-galactosylceramide (sphingoglycolipid, adjuvant) and a lactic acid-glycolic acid polymer (PLGA, average molecular weight 7000-17000; biodegradable polymer) are an adjuvant composition in a solid form; and a vaccine (NP(OVA +HPV+αGC), NP(OVA)+NP(αGC), NP(OVA+aGC), etc.) comprising an antigen of HPV (papillomavirus), etc. and said adjuvant composition has remarkably good immunogenicity (entire document, particularly, abstract, p. 2, left column, line 18 to p. 3, left column, line 2, p. 3, left column, lines 15-22, p. 3, right column, line 8 to p. 5, left column, line 7, p. 5, left column, line 15 to p. 5, right column, line 4, p. 6, right column, line 2 from the bottom to p. 7, left column, line 35, fig. 1, 2A, 2C, 3, supplementary table 1, supplementary fig. 2 and 3).
Thus, the art teaches a complex comprising an adjuvant and a biodegradable polymer. This combination is not in a single embodiment. However, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results of making an adjuvant composition comprising a complex between an adjuvant and a biodegradable polymer, see MPEP 2143 part (I)(A).
Claims 1-7, 9-10, 12-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over HO, H.M. et al. (Assessment of adjuvantation strategy of lipid squalene nanoparticles for enhancing the immunogenicity of a SARS-CoV-2 spike subunit protein against COVID-19, International Journal of Pharmaceutics, 18 August 2021, vol. 607, articles no. 121024, pp. 1-7, doi: 10.1016/ j.ijpharm.2021.121024, presented in IDS).
HO et al. indicates that: nanoparticles (SQ@NP; composite) comprising squalenc (terpenoid, adjuvant) and a lactic acid polymer (biodegradable polymer) are an adjuvant composition; and when a composition (S- protein with SQ@NP; vaccine) comprising said SQ@NP and a spike (S) protein of SARS-CoV-2 (coronavirus) was administered into a living body, the same significantly induced IgG antibody production and significantly induced production of cytokines such as IFN-γ in splenocytes, see (entire document, particularly, abstract, p. 2, left column, lines 4-51, p. 2, right column, line 1 to p. 3, right column, line 5, p. 4, left column, line 9 to p. 4, right column, line 16, fig. 1, 2, 4, 5).
Thus, the art teaches a complex comprising an adjuvant and a biodegradable polymer. This combination is not in a single embodiment. However, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results of making an adjuvant composition comprising a complex between an adjuvant and a biodegradable polymer, see MPEP 2143 part (I)(A).
Claims 1-10 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over GAO, X. et al. Chitosan modified squalene nanostructured lipid carriers as a promising adjuvant for frecze-dried ovalbumin vaccine. International Journal of Biological Macromolecules, 16 August 2021, vol. 188, pp. 855-862, doi: 10.1016/j.ijbiomac.2021.08.074, presented in IDS).
Gao et al. indicates that: nanoparticles (csNLC) comprising squalene (terpenoid, adjuvant) and chitosan (biodegradable polymer) are an adjuvant composition in solid form; and a lyophilized preparation (OVA- csNLC) comprising an antigen such as OVA, csNLC, and sucrose has excellent storage stability and when administered into a living body, significantly induces IgG antibody production and significantly induces production of cytokines such as IFN-y in splenocytes (entire document, particularly, abstract, p. 855, right column, line 11 to p. 856, left column, line 17, p. 856, left column, lines 36-39, p. 856, left column, line 4 from the bottom to p. 856, right column, line 12, p. 856, right column, line 37 to p. 857, left column, line 2, p. 857, left column, lines 13-26, p. 858, left column, line 10 from the bottom to p. 858, right column, line 9, p. 859, left column, lines 7-15, p. 859, right column, line 4 to p. 860, right column, line 3 from the bottom, table 2, fig. 2, 3, 5).
Thus, the art teaches a complex comprising an adjuvant and a biodegradable polymer. This combination is not in a single embodiment. However, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results of making an adjuvant composition comprising a complex between an adjuvant and a biodegradable polymer, see MPEP 2143 part (I)(A).
Claims 1-12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over VAN ROOIJ, E. M. A. et al. (Protective antiviral immune responses to pseudorabies virus induced by DNA vaccination using dimethyldioctadocylammonium bromide as an adjuvant. Journal of Virology. October 2002, vol. 76, no. 20, pp. 10540-10545, doi: 10.1128/jvi.76.20.10540-10545.2002, presented in IDS).
Van Rooij et al. indicates that when, after a vaccine composition comprising an adjuvant composition (SL-CD) in which squalene (terpenoid, adjuvant) was included in sulfolipo (SL)-cyclodextrin (B-cyclodextrin derivative) and DNA encoding a pseudorabies virus (PRV) derived protein was administered three times to pigs, the same were infected with PRV, virus shedding from said pigs was significantly reduced (entire document, particularly, abstract, p. 10540, left column, line 27 to p. 10540, right column, line 3, p. 10541, left column, lines 20-36, p. 10541, right column, lines 7-1 from the bottom, p. 10542, left column, lines 5-8, fig. 5A).
Thus, the art teaches a complex comprising an adjuvant and a biodegradable polymer. This combination is not in a single embodiment. However, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results of making an adjuvant composition comprising a complex between an adjuvant and a biodegradable polymer, see MPEP 2143 part (I)(A).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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