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 .
Claims 1-20 are pending and are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/25/23 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 14 and 20 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 14 recites, “A vaccine comprising a composition of claim 1…”, however, claim 1 does not mention composition, rather it mentions a nanoparticle. Furthermore, claim 1 recites more than one “composition”, such as inactivated IAV antigen and mannose conjugated chitosan. Therefore, it is unclear which composition claim 14 is referring to.
Claim 20 recites the limitation "the increased amount of IgA" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 102a1 as being anticipated by Renu et al. (Frontiers in Immunology, 2021, Vol. 12, pages 1-13).
The claimed invention is drawn to a nanoparticle comprising mannose conjugated
chitosan and an inactivated influenza A virus (IAV) antigen. The mannose chitosan encapsulates the inactivated IAV antigen. The nanoparticle further comprises a tripolyphosphate and the IAV antigen comprises inactivated swine IAV antigen or is from a H1N1, H1N2 or H3N2 virus. The composition comprising the nanoparticle is also part of a vaccine in a pharmaceutically acceptable carrier. The IAV is homologous, heterologous or heterosubtypic to an influenza A virus and it reduces transmission of the influenza A virus or reduces nasal shedding of the influenza A virus compared to a control within 4 days of exposure to the influenza A virus, or reduces the amount of influenza A in an upper respiratory tract of a subject by at least 1x10^1 TCID50/mL compared to a control.
The nanoparticle has a diameter of 500nm or less, or has an encapsulation efficiency of inactivated IAV antigen of at least 60%, or the nanoparticle elicits an increased amount of IgA antibody in a subject compared to a control.
*MPEP 2112.01 I. provides guidance on inherency related to composition claims. Specifically, when the structure recited in the reference is substantially identical to that of the claims, claimed properties are presumed to be inherent.
*MPEP 2112.01 II. provides guidance on inherency related to composition claims. Specifically, if the composition is physically the same, it must have the same properties.
*MPEP 2112.02 I. provides guidance on inherency related to composition claims. Specifically, prior art device anticipates a claimed process if the device carries out the process during normal operation.
Renu et al. teach the formulation of a nanoparticle composition comprising a mannose conjugated chitosan (mCs), which encapsulates inactivated (killed) antigens from a swine influenza virus. [see abstract and page 3] The swine influenza virus that provided the inactivated antigens is A/Swine/OH/FAH10-1/10 (H1N2) and Renu et al. refer to this nanoparticle composition as mCS NPs-KAg+Ch. [see first section of Materials and Methods] The mCs encapsulated 80% of the influenza antigens and the formulation of these mCs encapsulated antigens also included the addition of tripolyphosphate. [see Formulation of Experimental Vaccines section] Following the formulation of the nanoparticle composition, Renu et al. teach the intranasal administration to piglets at a dosage of 10^7 TCID50 equivalent of inactivated antigen. [see Experimental Plan section] The mCs killed influenza antigen containing nanoparticles are structurally the same as those of applicant’s invention. The encapsulation rate is higher than applicant’s minimum amount of at least 60% and since the antigen is from an H1N2 virus, it is heterologous to other influenza viruses, such as H3N2. Renu et al. report increased IgA levels in piglets following vaccination [see figure 2] reduced viral levels in the lungs of piglets [see Figure 6]. The administration of these nanoparticles to the piglets involved formulating the nanoparticles in a pharmaceutically acceptable carrier and therefore meets the requirements of a vaccine. The administration of these nanoparticles to piglets achieved reducing transmission of influenza A and eliciting an immune response since Renu et al. teach administering the same composition presently claimed to pigs intranasally and immune responses were observed.
Lastly, based on the structure of the composition being the same as applicant’s, it is inherent (see MPEP 2112.01 I) that the diameter is 500nm or less. In addition, the claim limitations of: reduces transmission of influenza A virus, reduces the nasal shedding of influenza A virus, reduces the amount of influenza A virus in the upper respiratory tract of a subject by at least 1x10^1TCID50/mL compared to a control, reduces the amount of the influenza virus within 4 days of exposure to the influenza A virus, and an increased amount of IgA antibody in respiratory tract of the subject compared to a control is also elicited, are inherent features of the nanoparticles of Renu et al. based on the guidance provided by MPEP 2112.01 II and MPEP 2112.02 I.
Therefore, Renu et al. anticipate the instant invention.
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) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over
Dhakal et al. (Frontiers in Immunology, 2018, Vol. 9, Article 934) and Jiang et al. (Biomaterials, 2008, Vol. 29, pages 1931-1939).
The claimed invention is drawn to a nanoparticle comprising mannose conjugated
chitosan and an inactivated influenza A virus (IAV) antigen. The mannose chitosan encapsulates the inactivated IAV antigen. The nanoparticle further comprises a tripolyphosphate and the IAV antigen comprises inactivated swine IAV antigen or is from a H1N1, H1N2 or H3N2 virus. The composition comprising the nanoparticle is also part of a vaccine in a pharmaceutically acceptable carrier. The IAV is homologous, heterologous or heterosubtypic to an influenza A virus and it reduces transmission of the influenza A virus or reduces nasal shedding of the influenza A virus compared to a control within 4 days of exposure to the influenza A virus, or reduces the amount of influenza A in an upper respiratory tract of a subject by at least 1x10^1 TCID50/mL compared to a control.
The nanoparticle has a diameter of 500nm or less, or has an encapsulation efficiency of inactivated IAV antigen of at least 60%, or the nanoparticle elicits an increased amount of IgA antibody in a subject compared to a control.
Dhakal et al. teach the formulation of a mucoadhesive chitosan nanoparticles, which encapsulates inactivated (killed) antigens from a swine influenza virus. [see abstract and page 3] The swine influenza virus that provided the inactivated antigens is A/Swine/OH/FAH10-1/10 (H1N2) and Dhakal et al. refer to this nanoparticle composition as CNPs-KAg. [see first section of Materials and Methods] The nanoparticles encapsulated 67% of the influenza antigens and the formulation of these encapsulated antigens also included the addition of tripolyphosphate. [see left hand column of page 6 and left column of page 3] Following the formulation of the nanoparticle composition, Dhakal et al. teach the intranasal administration to piglets at a dosage of 10^7 TCID50 equivalent of inactivated antigen. [see Experimental Design section] The chitosan particles with killed influenza antigen containing nanoparticles are structurally the same as those of applicant’s invention and had a diameter of about 500 nm. [see right column of page 11] The encapsulation rate is higher than applicant’s minimum amount of at least 60% and since the antigen is from an H1N2 virus, it is heterologous to other influenza viruses, such as H3N2. Dhakal et al. report increased IgA levels in piglets following vaccination [see figures 3 and 5] reduced viral levels in the lungs of piglets [see Figure 8]. The administration of these nanoparticles to the piglets involved formulating the nanoparticles in a pharmaceutically acceptable carrier and therefore meets the requirements of a vaccine. The administration of these nanoparticles to piglets achieved reducing transmission of influenza A and eliciting an immune response since Dhakal et al. teach administering the same composition presently claimed to pigs intranasally and immune responses were observed.
However, Dhakal et al. do not teach the use of mannose conjugated to chitosan.
Jiang et al. teach chitosan nanoparticles with conjugated mannose to encapsulate killed antigens of bacteria. They also teach that mannose can facilitate macrophage uptake. [see page 1-introduction] Jiang et al. teach that incorporating mannose improves delivery of the antigen to mice intranasally. [see section 2.4.1] Mice receiving the mannose chitosan containing killed antigen exhibited a survival rate of 70%. [see section 3.3.3]
It would have been obvious to one of ordinary skill in the art to modify the compositions and methods taught by Dhakal et al. in order to employ mannose conjugated to the chitosan nanoparticles. One would have been motivated to do so, given the suggestion by Dhakal et al. chitosan nanoparticles can facilitate delivery of inactivated influenza antigens and achieve immune responses capable of reducing influenza infections. There would have been a reasonable expectation of success, given the knowledge that including mannose conjugated to chitosan particles with encapsulated killed bacterial antigens improved immune responses through macrophage targeted uptake, as taught by Jiang et al. Furthermore, the claim limitations of: reduces transmission of influenza A virus, reduces the nasal shedding of influenza A virus, reduces the amount of influenza A virus in the upper respiratory tract of a subject by at least 1x10^1TCID50/mL compared to a control, reduces the amount of the influenza virus within 4 days of exposure to the influenza A virus, and an increased amount of IgA antibody in respiratory tract of the subject compared to a control is also elicited, are obvious features of the nanoparticles one of ordinary skill in the art would arrive at based on the teachings of Dhakal et al. and Jiang et al.
Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Conclusion
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671