CTNF 17/801,055 CTNF 82619 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election/Restrictions 08-25-02 Applicant’s election of Group I and species CpG in the reply filed on 12/1/2026 is acknowledged. Because applicant 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 § 818.01(a)). Status of the Claims Claims 40, 43, 48, and 71 have been withdraw as being directed to a non-elected invention. Claims 1-11, 13-21, 25-26, 28, are 74-100 are under examination at this time. Specification The use of trademarks has been noted in this application. A trademark should be capitalized wherever it appears and be accompanied by the generic terminology. Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner, which might adversely affect their validity as trademarks. Claim Objections 07-29-01 AIA Claim 8 is objected to because of the following informalities: Claim 8 should be amended to delete “is” in part d) so that the claim reads as “peptides from a pathogen protein [[is]] selected from the group . . . “ . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-01 AIA The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 07-31-03 AIA Claim 25-26, 79-82, and 97-99 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, because the specification, while being enabling for inhibiting or reducing COVID-19 in a subject , does not reasonably provide enablement for preventing COVID-19 in a subject . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims. Nature of the invention . The claims are directed to a method for preventing COVID-19 in a subject administering the claimed fusion protein comprising, inter alia , the RBD from SARS-CoV-2 spike protein. Breadth of the claims . The claims are broad, encompassing preventing COVID-19 in any subject. Guidance in the specification and working examples . There are several examples demonstrating the ability of the claimed fusion protein to induce neutralizing antibodies (in rats and macaques) and reduce viral load in lung tissue (in rats). However, none of the examples demonstrate that the claimed fusion protein was able to prevent COVID-19 in a subject. Given the breadth of the claims, the lack of guidance in the specification, and the lack of predictability of the art, it would require undue experimentation for one skilled in the art to use the claimed composition and method . 07-36 AIA The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. 07-36-01 AIA Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 18, from which claim 19 depends, states that the excipient comprises a CpG oligonucleotide and aluminum phosphate. Claim 19 states that the excipient comprises histidine, histidine HCl-H20, arginine HCl, polyoxyethylene (20) sorbitan monooleate, hydrochloric acid, sodium chloride, 2-phenoxyethanol, and water. Claim 19 does not further limit the excipient of claim 18. Instead, claim 19 changes the scope from CpG oligonucleotide and aluminum phosphate to histidine, histidine HCl-H20, arginine HCl, polyoxyethylene (20) sorbitan monooleate, hydrochloric acid, sodium chloride, 2-phenoxyethanol, and water . Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Allowable Subject Matter SEQ ID NOs: 227, 235, 235 and 355 are free of the prior art. Claims 1-7,9-11, 13-18, 20-21, 28, 74-78, 83-96, and 100 are allowable. Citation of Pertinent Prior Art 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Du et al. (Vaccine, 2007, 25:2832–2838) teaches RBD-Fc comprising the RBD from the SARS-CoV spike protein. Du et al. does not teach that the fusion protein also contains Th and/or CTL epitopes from the N, M or S protein or SARS-CoV . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 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 at 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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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672 Application/Control Number: 17/801,055 Page 2 Art Unit: 1672 Application/Control Number: 17/801,055 Page 3 Art Unit: 1672 Application/Control Number: 17/801,055 Page 4 Art Unit: 1672 Application/Control Number: 17/801,055 Page 5 Art Unit: 1672 Application/Control Number: 17/801,055 Page 6 Art Unit: 1672