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
Applicant’s amendment filed on August 4, 2026 is acknowledged. Claims 1-15 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 15, 2026 has 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.
Rejection of Claims 1-7, 9-11 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Mudgal et al. (Human Vaccines and Immunotherapeutics, 2020, Vol. 16, p. 2921-2931) is maintained.
Response to Applicant’s arguments
Applicants’ arguments have been fully considered but fail to persuade. Applicant argues that Mudgal refers only once to the administration to the ocular mucosa or urogenital mucosa and this sentence is from a broad paragraph in Mugdal.
In response, it is the Examiner’s position that Mugdal is a review article and a single mention of administering the SARS-CoV-2 vaccine to the ocular and vaginal mucosa is sufficient to anticipate the present claims.
Since Mudgal et al. discloses a method of prevention of COVID-19 in humans comprising administering a vaccine against SARS-CoV-2 comprising the SARS-CoV-2 S protein into the ocular and vaginal (urogenital) mucosa (see Design strategies for mucosal vaccine against SARS-CoV-2 on page 2922, page 2923 under Antigen selection), Mugdal anticipates the present claims.
Rejection of Claims 1-6, 9-11 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Hsu et al. (US Patent Application Publication US 2021/0346491) is maintained.
Response to Applicant’s arguments
Applicants’ arguments have been fully considered but fail to persuade. Applicant argues that Hsu et al. (US Patent Application Publication US 2021/0346491) is not prior art because the priority date of the present Application is March 22, 2021 and the filing date of the US 2021/0346491 is May 7, 2021.
In response, contrary to Applicant’s assertion the priority date of the 2021/0346491 Application is May 8, 2020 since it claims priority to a provisional application 63022017 that provides written description support for the administering SARS-CoV-2 vaccine to the mucosa (see page 3) claimed in US 2021/0346491. Thus, Hsu et al. (US Patent Application Publication US 2021/0346491) is prior art.
Since Hsu et al. discloses a method of prevention of COVID-19 in humans comprising administering a vaccine against SARS-CoV-2 comprising the SARS-CoV-2 S protein into vaginal (urogenital) mucosa (see paragraph [0020], [0046], Examples 1-4), Hsu anticipates the present claims.
Claim Rejections - 35 USC § 103
Rejection of Claims 8 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mudgal et al. (Human Vaccines and Immunotherapeutics, 2020, Vol. 16, p. 2921-2931) or Hsu et al. (US Patent Application Publication US 2021/0346491) as applied to claim 1 and further in view of Yoon et al. (PLOS, 2015, p. 1-16 in IDS on 9/20/2023) is maintained.
Response to Applicant’s arguments
Applicants’ arguments have been fully considered but fail to persuade. Applicant argues that the claimed invention demonstrates that vaccination according to the invention allows for the development of acquired immunity without the onset of systemic disease, unlike in animals immunized intranasally (see Example 3 of the specification). Applicant argues that Mugdal does not teach, nor suggest these advantages of the claimed invention.
In response, Examiner notes that since Mudgal et al. discloses a method of prevention of COVID-19 in humans comprising administering a vaccine against SARS-CoV-2 comprising the SARS-CoV-2 S protein into the ocular and vaginal (urogenital) mucosa (see Design strategies for mucosal vaccine against SARS-CoV-2 on page 2922, page 2923 under Antigen selection), Mugdal anticipates the present claims. The advantages argued by Applicant are not recited in the present claims. Applicant’s arguments are not found persuasive and thus the rejection is maintained.
Double Patenting
Rejection of Claim 1-15 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/283,067 is withdrawn in view of Applicant’s argument.
Contact Information
THIS ACTION IS MADE FINAL. 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 extension fee 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 AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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