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 .
Status of the Claims
Claims 1-6, 9-10, 23-32, 36, 39-40 and 42-44 are pending.
Election of Invention
Applicants’ election without traverse (see page 1 of Remarks filed on 06/10/2026), of the invention of Group I (claims 1-6, 10, 23-31), is acknowledged and entered.
Applicants’ election of influenza virus A antigen, as the elected species of a microbial antigen (see page 2 of Remarks filed on 06/10/2026), is acknowledged and entered.
Because Applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 10, 23-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected species. Claims 32, 36, 39-40 and 42-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected invention. Therefore, claims 1-6, 9 and 25-31 are subject of the Office action below.
Priority
This application filed on 10/09/2023, is a 371 of PCT/US2022/024059, filed on 04/08/2022, which claims priority to U.S. Provisional Application No. 63/172,628, filed on 04/08/2021.
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.
Claims 1-4, 25-26 and 29-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al (hereinafter “Xu”, Nanoscale, 2016, 8, 3785-3794).
By way of a background, Applicants’ invention is drawn to composition comprising: i) a polyethyleneimine (PEI) modified graphene oxide (GO) nanoparticle (GO-PEI or GP); and ii) a microbial antigen, vaccine and/or a pharmaceutical agent (see, e.g., pages 1-2 of the specification).
Regarding claims 1-2 and 4, Xu (see, e.g., abstract, §s 2.1-2.2, 2.8 and Figure 1), teaches a composition comprising: i) a PEI-modified GO or PEGylated PEI-modified GO; and ii) a microbial antigen (urease B, an antigen for helicobacter pylori), as a vaccine composition.
Regarding claim 3, Xu (see Figure 6), discloses nanosheets
Regarding claim 25, Xu (see § 3.2, page 3791, left column ¶), teaches ratio of 2.5:1 (2.5/1 = 2.5), which lies inside the claimed ratio of 10:1 to 1:10 (10.0 to 0.1). A specific example in the prior art which is within a claimed range anticipates the range. Please MPEP § 2131.03.
Regarding claim 26, Xu (see, e.g., abstract), discloses an adjuvant.
Regarding claim 29, Xu (see Figure 1), discloses nanoparticle size of about 50 nm to about 250 nm.
Regarding claim 30, Xu (see, e.g., §s 2.2, 3.1 and Figure 1), discloses measuring zeta potentials of the nanoparticles.
Regarding claim 31, Xu (see, e.g., abstract), discloses a vaccine.
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.
Claims 1-6, 9, 25-26 and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Xu (Nanoscale, 2016) as applied to claims 1-4, 25-26 and 29-31 above and in view of Shoji et al (hereinafter “Shoji”, Human Vaccines & Immunotherapeutics, 2013, 9(3), 553-560).
The limitation of claims 1-4, 25-26 and 29-31, as well as the corresponding teachings of Xu are described above, and hereby incorporated into the instant rejections.
The invention of claims 5-6 and 9 differ slightly from claims 1 and 6 in that claims 5-6, 9 require that the microbial antigen is an influenza virus hemagglutinin (HA) protein.
Although Xu (see discussions above), teaches a vaccine composition comprising: i) GO-PEI or PEGylated GO-PEI; and ii) a microbial antigen (urease B, an antigen for helicobacter pylori), Xu differs from claims 5-6 only insofar as Xu is not explicit in teaching use of an influenza virus antigen (e.g., HA protein) in the formulation of a vaccine. However, the claimed invention would have been obvious over Xu.
This is because at the time of the instant invention, it was known in the art that HA protects against influenza virus challenge. For example, Shoji teaches trimeric HA protects mice from a lethal influenza virus challenge (see abstract and discussions therein).
Accordingly, at the time of the instant invention, one skilled in the art would have envisaged an influenza virus vaccine composition comprising: i) GO-PEI or PEGylated GO-PEI; and ii) a microbial antigen (HA protein), in the disclosures of Xu and Shoji. A person skilled in the art would have had a reasonable expectation that the administration of the composition to a subject (e.g., mouse), in need thereof, would protect the subject from a lethal influenza virus challenge.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Claims 1-6, 9 and 25-31 are rejected under 35 U.S.C. 103 as being unpatentable over Xu (Nanoscale, 2016) in view of Shoji (Human Vaccines & Immunotherapeutics, 2013) as applied to claims 1-6, 9, 25-26 and 29-31 above and further in view of Mallick et al (hereinafter “Mallick”, Vaccine, 2011, 29, 1657-1665).
The limitation of claims 1-6, 9, 25-26 and 29-31, as well as the corresponding teachings of Xu and Shoji are described above, and hereby incorporated into the instant rejections.
The invention of claim 27 differ slightly from claim 26 in that claim 27 requires that the adjuvant is CpG-ODN.
Although Xu and Shoji (see discussions above), combine to teach an influenza virus vaccine composition comprising: i) GO-PEI or PEGylated GO-PEI; and ii) a microbial antigen (HA protein), Xu and Shoji do not combine to explicitly disclose CpG-ODN as an adjuvant. However, the claimed invention would have been obvious over Xu and Shoji.
This is because at the time of the instant invention, it was known in the art that the immunogenicity of an influenza vaccine can be enhanced by incorporating CpG-ODN. For example, Mallick teaches enhancement of an influenza vaccine by incorporating CpG-ODN (see abstract and discussions therein).
Accordingly, at the time of the instant invention, one skilled in the art would have envisaged an influenza vaccine composition comprising: i) GO-PEI or PEGylated GO-PEI; and ii) a microbial antigen (HA protein) and iii) CpG-ODN as an adjuvant, in the disclosures of Xu, Shoji and Mallick. A person skilled in the art would have had a reasonable expectation that the incorporation of CpG-ODN, would enhance the immunogenicity of the influenza vaccine.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
Regarding claim 28, the recited ratio of GO-PEI to microbial antigen to adjuvant, a result effective variable that would have been routinely determined and optimized by one skilled in the art. Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
It is noted that no criticality (emphasis added) has been demonstrated in the specification with regard to the claimed ratio of GO-PEI to microbial antigen to adjuvant recited in claim 28.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Conclusions
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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