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 .
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Instant claim 14 in the present 10/31/2025 amendment, was cancelled on 4/14/2023. In addition, claim 22, currently presented, was cancelled in the 5/28/2024 amendment. In the interest of compact prosecution, claims 14-25 have been renumbered 15-26, to be consistent with claim numbering carried throughout prosecution since May 2, 2022.
Information Disclosure Statement
The references listed in information disclosure statements (IDS’s) submitted on 11/11/25 have been considered by the examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 7, 10, 15, 17, 23, and 24 are rejected under 35 U.S.C. 102(a)(1)/(a)(2)as being anticipated by Galili et al. (USPgPub 2016/0256388, cited previously).
In reply to the teachings of Galili et al., applicant states that the instant claims require that the instant carrier reduces the spread of infection by binding the carrier to at least one target area of host cells in a respiratory tract. Applicant reiterates the components of the instant carrier is fabricated using a bottom-up or a top-down method and comprises a core and a functionalized surface and a maximum size of the carrier in at least one dimension is less than 1000 nm. The functionalized surface comprises protruding glycoprotein peptide structures that at least partially resemble protruding peptide structures of the pathogen comprise epitopes to be used as a vaccine thereby providing a gained advantage to an immune system of the host to fight a disease caused by the pathogen. The instant carrier is internalized into epithelial cells of the respiratory tract of the host after the carrier binds to the at least one target area. Applicant asserts that the amended claims are novel, non-obvious, and patentable for these reasons.
The amendments to the claims have been fully considered, but are found unpersuasive. In at least paragraph [0009] and Example 2 beginning on page 17, Galili et al. teach inhibiting progression (spread) of influenza virus infection, as required by the preamble of instant claims 1 and 15 and the viral pathogen of claim 10. Galili et al. accomplish the method of inhibiting the progression of infectious respiratory diseases by administering liposome nanoparticle carriers (fabricated core) comprising functionalized protrusions/ spikes presenting a plurality of influenza sialic acid (SA) and α-gal epitopes that bind to corresponding receptors on cells within the respiratory tract epithelium and mimic surface properties of the pathogen, see paragraphs [0009, 0011, 0013, 0015, 0035, 0050, 0061, 0066, 0075+], Figures 2 and 4, and claims 1, 2, and 7-10, as required by instant claims 2, 7 and 17. The carrier of Galili et al. is decorated with epitopes on the surface used to inhibit the progression of respiratory diseases upon administration, meets the instant limitations regarding providing a gained advantage of the host’s immune system in claim 1, as required in instant claims 1 and 15.
Galili et al. do not specifically teach that the liposome carrier expressing influenza sialic acid (SA) and α-gal epitopes that bind to corresponding receptors on epithelial cells within the respiratory tract, is internalized, as recited in instant claims 1 and 15.
However, paragraph [0142] of the instant published disclosure, USPgPub 2022/0280635, teach (underlining provided for convenience, noting the excerpt cites prior art in brackets):
…peptides or other structures can be similar or substantially similar to those found in viral glycoprotein spikes and/or protein protrusions, thus, in some arrangements, mimicking (e.g., at least substantially or approximately) at least some of the viral surface properties that assist with the binding of the carrier to certain receptors (e.g.,…sialic acid…). …Alternatively or additionally, the carrier's ability to at least partially inhibit entry of viruses can be enhanced by… attaching targeting motifs which are known to bind to the target receptor allowing selective internalization in target cells [6-9,20].
Therefore, the liposome carrier expressing influenza sialic acid (SA) and α-gal epitopes that bind to corresponding receptors on epithelial cells within the respiratory tract of Galili et al. are also internalized, as required in claims 1 and 15. When the structure recited in the reference is substantially identical to that of the claims, the claimed functions are also the same. MPEP § 2112.01. Galili et al. specifically teach influenza virus binding to the multiple SA epitopes on the α-gal/SA liposomes in the targeted area of the respiratory tract in Figure 2.
Paragraph [0059] of Galili et al. anticipate that the a-gal/SA liposomes are further sonicated to reduce their size to a size lower than 300 nm, anticipating the maximum size of the carrier in at least one dimension is less than 1000 nm, as required by claims 1 and 15. Paragraphs [0069 and 0078] of Galili et al. anticipate the liposomes size range between 1-500 nm or preferably 200 nm, anticipating instant claims 23 and 24.
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 8, 9, and 18 remain rejected under 35 U.S.C. 103 as being unpatentable over Galili et al. as applied to claims 1, 2, 7, 10, 15, 17, 23, and 24 above, and further in view of Hu et al. (WO 2017/165506), cited previously.
No separate argument was presented from applicant regarding this rejection, which is maintained for reasons of record.
Claims 11 and 19 remain rejected under 35 U.S.C. 103 as being unpatentable over Galili et al. as applied to claims 1, 2, 7, 10, 15, 17, 23, and 24 above, and further in view of Rabi et al. (Pathogens. 20 March 2020; 9: 231, previously of record).
No separate argument was presented from applicant regarding this rejection, which is maintained for reasons of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dickey et al. (Journal of Virology. 2011; 85 (17): 9023-9030) supports the teachings in paragraph [0142] of the instant published disclosure (USPgPub 2022/0280635) that sialic acid receptors are the primary means for influenza binding and infection and are required for cellular internalization, see the abstract and Figures 4, 6, and 7.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Janet L Andres can be reached at 571-272-0867. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Shanon A. Foley/ Primary Examiner, Art Unit 1671