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 .
The Examiner of the present Application has changed to Agnieszka Boesen.
Restriction/Election
Applicant’s response filed on June 29, 2026 to the restriction requirement on January 29, 2026 is acknowledged. Applicant elected the species of ocular mucosa, a virus, a coronavirus, mRNA coding for one or more antigens and an envelope protein.
Claims 1-15 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 20, 2023 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)(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 1-9, and 12-15 are rejected under 35 U.S.C. 102(a)(2) as anticipated by Yadavalli et al., (WO/2020/210376 in IDS on 9/20/23).
Regarding present claims 1-8 and 12. Yadavalli et al, disclose a method for the prevention and/or the treatment of a viral infection comprising administering to the ocular mucosa of a human a composition comprising a marker such as a dye and the viral antigen envelope protein in form of mRNA carbonized into the HPAC (see paragraphs [0035, 0085, 0093, 0131] and claims 1-89). Yadavalli et al, disclose a Coronavirus (see paragraph [00131]).
Regarding present claims 14-15. Yadavalli et al. discloses additional substances including additives, adjuvants and carriers (see claim 71).
Thus, by this disclosure Yadavalli et al. anticipate the present claims.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Yadavalli et al., (WO/2020/210376 in IDS on 9/20/23) in view of Yoon et al. (PLOS, 2015, p. 1-16 in IDS on 9/20/2023).
Yadavalli et al. teach the claimed invention as discussed above, they don’t teach using an applicator or administering the vaccine.
Regarding present claims 10 and 11. Yoon teaches eye drop applicator for administering the eye drops for vaccination (see Materials and Methods).
It would have been prima facie obvious to use an applicator to administer eye drops for the vaccination purposes as taught by Yoon, because Yoon teaches generation of systemic and mucosal responses administered eyedrop live attenuated influenza vaccine (see Results and Figure 1).
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/283,061.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to A method for the prevention and/or the treatment of an infection caused by at least one pathogen, comprising a marker is administered on the ocular mucosa and/or the urogenital mucosa.
The claims of the copending Application are drawn to A method for the prevention and/or the treatment of Covid-19, characterized in that it wherein an immunogenic or vaccine composition against SARS-CoV-2 is administered on the ocular mucosa and/or the urogenital mucosa.
The present claims and the claims of the copending application recite methods of vaccination against viral infection via mucosa. The species of SARS-CoV-2 in the copending application anticipates the genus of a viral pathogen recited in the present claims. Additionally, present claim 12 recites a coronavirus. Thus, the present claims are obvious over the claims of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Contact Information
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.
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.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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