Notice of Pre-AIA or AIA Status 1. 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 Status of Claims 2. Applicant 's preliminary amendment of the instant application, which was originally submitted on FILLIN "Identify the term that is a trade name or mark used in commerce." \d "[ 1 ]" 11/21/2023 and later amended on FILLIN "Identify the term that is a trade name or mark used in commerce." \d "[ 1 ]" the same day , is acknowledged by the Examiner . Claims 1 – 14 are pending and under review . Priority 3. The instant application is a FILLIN "Identify the term that is a trade name or mark used in commerce." \d "[ 1 ]" National Stage Entry of International Patent Application No. FILLIN "Identify the term that is a trade name or mark used in commerce." \d "[ 1 ]" PCT/KR2022 / 007697 filed on FILLIN "Identify the term that is a trade name or mark used in commerce." \d "[ 1 ]" 05/30/2022 and claims priority to FILLIN "Identify the term that is a trade name or mark used in commerce." \d "[ 1 ]" Korean Patent Application No. FILLIN "Identify the term that is a trade name or mark used in commerce." \d "[ 1 ]" 20220066317 filed on FILLIN "Identify the term that is a trade name or mark used in commerce." \d "[ 1 ]" 05/30/2022 and United States Provisional Application No. 63149310 filed on 05/28/2021 . Priority cannot be awarded to any of the claimed applications at the time of this Office Action for the following reasons: Applicant’s claim for the benefit of a prior-filed United States provisional application under 35 U.S.C. 119(e) or under 35 U.S .C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. FILLIN "Insert the appropriate statutory section(s)." 112(a) . The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc. , 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, United States Provisional Application No. 63149310 filed on 05/28/2021 , fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. While SEQ ID NOs: 1 – 4 are taught in the provisional application, the written description of the provisional application does not support and enable the subject matter of the instant claims . Moreover, t he provisional application also fails to teach the composition further comprising porous silica particles with specific properties, including the diameter, charge, and weight ratio to the nucleic acid molecule, as the carrier. The provisional application fails to provide support or to provide any suggestion to easily reduce to practice, for a vaccine comprised of the desired nucleic acid molecule of SEQ ID NOs: 1 – 4 against a virus. Thus, the breadth of the instant claims far overreaches the provisional disclosure. Accordingly, claims 1 – 14 are not entitled to the benefit of the provisional application . Applicant has not provided an English translation of FILLIN "Identify the term that is a trade name or mark used in commerce." \d "[ 1 ]" Korean Patent Application No. FILLIN "Identify the term that is a trade name or mark used in commerce." \d "[ 1 ]" 20220066317 filed on FILLIN "Identify the term that is a trade name or mark used in commerce." \d "[ 1 ]" 05/30/2022 that complies with 37 CFR 1.55. An English language translation of a ny non-English language foreign application is required ( i ) when the application is involved in an interference or derivation proceeding; (ii) when necessary to overcome the date of a reference relied upon by the Examiner ; or (iii) when specifically required by the Examiner . Should Applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application. Regardless, the current U.S. effective filing date of claims 1 – 14 is the international filing date, i.e., 05/30/2022. Information Disclosure Statement 4. The information disclosure statement s (IDS) submitted on FILLIN "Identify the term that is a trade name or mark used in commerce." \d "[ 1 ]" 11/21/2023, 10/30/2024, 03/25/2025, and 05/14/2025 ha ve been considered by the Examiner . Notably, the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Thus, unless the references have been cited by the Examiner on form PTO-892, they have not been considered. Specification 5. The use of the terms DegradaBALL ™ on pages 45 – 54 , and possibly others in the specification, which is a trade name or a mark used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, ℠ , or ® following the terms. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are 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 commercial marks. Applicant is required to properly annotate all trade names and/or marks that are present in the specification , regardless of whether or not the trade name is registered to the Applicant, as is the case in the instant specification . 6. The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant ’s cooperation is requested in correcting any errors of which Applicant may become aware in the specification. Claim Objections 7 . Claim s 2 , 6, and 8 – 14 are objected to because of the following informalities: There is a typographical error in claim 2, line 2. The phrase “sequence forms a” should be amended to read “sequence that forms a”; There is a grammatical error in claim 6. The first letter of every viral family should be capitalized; Claim s 8 – 14 , line 1 recites the phrase “ A virus vaccine composition ”. This is grammatically incorrect. It is recommended that the phrase read “ FILLIN "Enter claim indentification information" \* MERGEFORMAT A vaccine composition against a virus ” ; In claim 14, line 2, it is ambiguous that the weight ratio of the nucleic acid molecule to the porous silica particles must fall in the range of 1:1 to 1:30. It is recommended that “1:1 to 30” be amended to “ 1:1-30 ”. Recommended amendments are underlined. Appropriate correction is required. Claim Rejections - 35 USC § 112 35 USC § 112(b) 8 . The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION. — The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the Applicant regards as his invention. 9 . Claim s 1 – 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the Applicant), regards as the invention. 1 0 . Claim FILLIN "Enter claim indentification information" \* MERGEFORMAT 1 is vague and unclear, which renders the claim indefinite. FILLIN "Enter claim indentification information" \* MERGEFORMAT Line 2 recites “ RBD-(L)n-X ” . The direction that the sequence should be read is not clear. Is the 5’ end at the RBD or X? In turn, w here is the 3’ end? The presence of multiple very different interpretations of the same claim language renders the claim indefinite. This rejection affects all dependent claims, i.e., claims 2 – 7. This rejection also affects claims 8 – 14 as the directionality is unclear . For this examination , it will be inferred that FILLIN "Enter claim indentification information" \* MERGEFORMAT the 5' end is at the RBD end and the 3' end is at the X end for comparison against the prior art . However, an appropriate amendment is required. 11. Claim 2 is vague and unclear, which renders the claim indefinite. FILLIN "Enter claim indentification information" \* MERGEFORMAT Line 2 recites “ FILLIN "Enter claim indentification information" \* MERGEFORMAT forms a triplet by the receptor-binding domain thereof ”. It is not clear what is meant by the RBD is forming a triplet . The instant specification discloses that the nucleic acid molecule encodes a receptor binding domain (RBD) that forms a stable structure (page 3, paragraph 6). Mature, stable surface proteins of class one fusion viruses, including coronaviruses, often form a trimer as part of its fusion machinery , including the RBD . Is this what is meant by a triplet of the RBD? If so, the claim should be amended to read “trimer” instead of “triplet” ; although, this could also be a translation error . Regardless , an appropriate amendment is required. 12. Claim 4 is vague and unclear, which renders the claim indefinite. FILLIN "Enter claim indentification information" \* MERGEFORMAT Line s 1 and 2 recite “ FILLIN "Enter claim indentification information" \* MERGEFORMAT wherein the RBD is the nucleotide sequence of SEQ ID NO: 2 ”. The RBD is a protein, not a nucleic acid. Thus, the RBD cannot be represented by nucleotide sequence. In the interest of compact prosecution , it will be inferred that “the RBD is encoded by the nucleotide sequence of SEQ ID NO: 2”. However , an appropriate amendment is required. 13. It is noted that any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this Office Action. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejection(s) and art may be applied in a subsequent Office Action. 35 USC § 112 (a) 14. 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. 35 USC § 112(a) – Written Description 15. Claims 8 – 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. "The purpose of [the written description requirement] is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification"); LizardTech Inc. v. Earth Resource Mapping Inc., 424 F.3d 1336, 1345, 76 USPQ2d 1724, 1732 (Fed. Cir. 2005) . This requirement is separate and distinct from the enablement requirement. To satisfy the written description requirement for a claimed genus, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention at the time of filing. See In re Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345, 54 USPQ2d 1915, 1917 (Fed. Cir. 2000) . “ Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed . The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. ” See In re Enzo Biochem , Inc. v. Gen – Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002). See also MPEP § 2163. The written description requirement may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the claimed genus. See In re University of California v. Eli Lilly & Co., 1 1 9 F.3d 1559, 1566, 43 USPQ2d 1398 , 1404 (Fed. Cir. 1997) ; and Juno Therapeutics, Inc. v. Kite Pharma, Inc. , 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) . A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, the Applicant must describe a sufficient variety of species to reflect the variation within the genus. See In re AbbVie Deutschland GMBH v. Janssen Biotech , 759 F.3d 1285, 1300, 111 USPQ2d 1780 , 1790 (Fed. Cir. 2014). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See In re Enzo Biochem , 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) . "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." See In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) . The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. The Court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is. This is because functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Further, the Court held that to adequately describe a claimed genus, an Applicant must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus.” The description needed to satisfy the written description varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. See In re University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); In re AbbVie Deutschland GMBH v. Janssen Biotech , 759 F.3d 1285, 1300, 111 USPQ2d 1780 , 1790 (Fed. Cir. 2014) ; In re Ariad Pharms., Inc. v. Eli Lilly & Co. , 598 F.3d 1336, 94 USPQ2d 1161 (Fed. Cir. 2010) ; and In re Capon v. Eshhar , 418 F.3d at 1357, 76 USPQ2d at 1084 . Claims 1 – 14 are drawn to a nucleic acid molecule having the sequence RBD-(L)n-X , wherein X is SEQ ID NO: 1, that can be formulated as a vaccine composition against a virus . Further limitations include that the RBD is a partial, virus-derived sequence from the RBD of Herpesviridae , Orthomyxoviridae , R habdoviridae , P aramyxoviridae , P apilomaviridae , A denoviridae, P arvoviridae , A stroviridae , R eoviridae, B unyaviridae , A rteriviridae , C aliciviridae , H epeviridae , B ornaviridae , A renaviridae , T ogaviridae , F iloviridae, R etroviridae , F laviviridae, and C oronaviridae , as disclosed in instant claim 6 ; or Colacovirus , Decacovirus , Duvinacovirus , Luchavirus , Minacovirus , Minunacovirus , Myotacovirus , Nyctacovirus , Pedacovirus , Rhinacovirus , Setracovirus , Soracovirus , Tegacovirus , Embecovirus , Hibecovirus , Merbecovirus , Nobecovirus , Sarbecovirus , Brangacovirus , Cegacovirus , Igacovirus , Andecovirus , Buldeco virus and Herdecovirus , which are all subgenera of C oronaviridae (see Zhou, Z., Qiu, Y., and Ge, X. , The taxonomy, host range and pathogenicity of coronaviruses and other viruses in the Nidovirales order. Animal diseases , 1 (1), 5 ; Published 04/23/2021) , as required in instant claim 7 . This corresponds to a massive genus with an innumerable number of possible sequences for the RBD alone. An other limitation iterates that the nucleic acid molecule is carried on a carrier selected from the group of a viral carrier, virus-like particles (VLPs), positively charged polymer, liposome, lipid nanoparticles, gold, semiconductor quantum dots, carbon nanotube , and porous silica particles , as defined in instant claim 9. At a minimum, claims 1 – 14 are generic and encompass a vaccine comprised of any partial RBD virus-derived sequence from any virus that is within the viral families listed. Moreover, the vaccine composition must have a preventative function, i.e., elicit neutralizing antibodies in the subject, which would be uncommon with just any random RBD sequence. Thus, this creates an enormous breadth of vaccine compositions with the RBD sequence alone that grows exponentially larger with the different carriers, which Applicant does not provide adequate written description for the claimed genus. When there is substantial variation within the genus, as here, one must describe a sufficient variety of species to reflect the variation within the genus to provide a “representative number” of species. The claims are drawn to several genera that are comprised of a large magnitude of vaccines against 20 different viral families, yet, the specification has only adequately described, and successfully reduced to practice, one vaccine with t he partial RBD sequence derived from coronavirus disease 2019 (COVID-19), i.e., SEQ ID NO: 2, with an associated linker sequence (L), i.e., SEQ ID NOs: 3 or 4 , and stabilization sequence (X), i.e., SEQ ID NO: 1 , that is carried by porous silica particles and elicits antibodies with neutralizing abilities (page 51, paragraphs 223 – 227) . This is not representative of the extremely large genus of partial, virus-derived RBD sequences claimed. One of ordinary skill in the art cannot conclude that Applicant was in possession of the innumerable combinations of vaccine compositions encompassed by the disclosed genera. This genus grows even larger when expanded to include the numerous carrier options that would need to be optimized per each different RBD sequence and subsequent vaccine composition. Absent the single disclosed nucleic acid molecule and associated carrier, the skilled artisan generally would not be able to visualize or otherwise predict, a priori , each individual sequence utilized and, thus, the innumerable vaccine compositions . In general , it is clear that the breadth of the recited genera in the claims far overreaches the Applicant’s contribution. In the absence of a representative number of examples, the specification must at least describe the structural features that are required for the claim function. In the instant case, the specification should explain the RBD residues that would still allow for a nucleic acid to be designed with the given L and X sequence, then formulated as a vaccine that elicits an effective immune response in a patient . However, the specification fails to describe any substantive structural limitations as to establish the criteria necessary to design a partial, virus-derived nucleotide sequence with the RBD from the different viral families and an immune response against the virus thereof . At best, the specification contemplates the use of BLAST to identify functional homologs based on sequence homology. However, this is not sufficient to describe members of the claimed genus because such methods access online databases that are continually being updated as sequencing technology improves. As a result, they are not a static source of information. Therefore, one having ordinary skill in the art would readily appreciate that relying on a non–patent source that is continuously subject to change as a means to identify members of the claimed genus does not sufficiently meet the written description requirement. The art teaches that protein chemistry is an extremely unpredictable area of biotechnology, wherein even a single substitution can change the biological property of a peptide . For example, Burgess, W. H., et. al., (Possible dissociation of the heparin–binding and mitogenic activities of heparin–binding (acidic fibroblast) growth factor–1 from its receptor–binding activities by site–directed mutagenesis of a single lysine residue. The Journal of cell biology, 111 (5 Pt 1), 2129–2138; Published 11/1990), hereby Burgess, teaches that replacement of a single lysine residue by a glutamic acid residue can lead to substantial loss of receptor binding and biological activity of a protein (page 2129; abstract). Moreover, Friedberg, I., (Automated protein function prediction––the genomic challenge. Briefings in bioinformatics , 7 (3), 225–242; Published 01/25/2006), hereby Friedberg, teaches that homology–based transfer is not reliable for functional annotation even with high alignment percentages (page 227, second column). Friedberg also teaches that identification of functionally significant sub–regions is critical to functional annotation, and that often addition, deletion, or re–shuffling of domains can lead to errors in annotation (page 227, second column; page 228, first paragraph). Furthermore, Friedberg teaches that as databased and, thus, diversity of sequences, get larger, sequence–based tools are not sensitive enough to identify functional protein similarity (page 228, first full paragraph). Thornton, J., (Structural genomics takes off. Trends in biochemical sciences , 26 (2), 88–89; Published 02/01/2001), hereby Thornton, teaches that the same protein structure is often seen in apparently different homologous families with different functions. Thornton further describes examples of little correlation between specific binding function and overall protein structure (page 992, right column, lines 2 – 10). Thus, when taken with the teachings of Burgess, Friedberg, and Thornton one having ordinary skill in the art would readily appreciate that sequence homology alone cannot serve as the basis to describe members of the genus that have the recited function , wherein even a single substitution within the sequence of the RBD, L, or even X, could change the effectiveness of the vaccine and that the carrier molecule would be a result effective parameter requiring optimization that could also influence effectiveness of the vaccine composition . In summary, these examples teach that the biological function of peptide variants is unpredictable because even a single mutation can abolish activity or give a different function. In other words, a single mutation in the partial sequence of the RB D , as encoded by the nucle ic acid molecule , could result in hindered function . Also, any combination of an RBD sequence with the given linker and stabilization sequence will not inherently provide protective immunization responses as a vaccine composition. Thus, while Applicant has described a species within the genus recited, and the art may provide more, each genus is very large and would encompass peptide structures that cannot be visualized from the prior art or instant disclosure. One having ordinary skill in the art cannot determine the structures encompassed by the claimed genera. Thus, the described species cannot be considered representative of the entire recited genus. Overall, the claims as currently written are not adequately described and one of ordinary skill in that art would readily appreciate that Applicant was not in possession of the claimed genera at the time of filing. At present, sufficient written description has been provided for the exact nucleic acids that encode for the polypeptide that w as shown to generate neutralizing antibodies, as defined in the instant specification, i.e., the sequence RBD-(L)n-X, wherein X is SEQ ID NO: 1, L is SEQ ID NOs: 3 or 4, and RBD is SEQ ID NO: 2. 35 USC § 112(a) – Scope of Enablement 16. Claims 8 – 14 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 FILLIN "Identify claimed subject matter for which the specification is enabling" \* MERGEFORMAT a nucleic acid with a partial RBD sequence derived from COVID-19 (SEQ ID NO: 2), linker region (SEQ ID NOs: 3 or 4), and stabilization sequence (X; SEQ ID NO: 1) that can be formulated as a vaccine with porous silica particles as the carrier , does not reasonably provide enablement for merely any viral RBD, linker, and stabilization peptide combination causing an immune response that will generate neutralizing antibodies and, thus, function as a vaccine and prevent infection . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to FILLIN "Enter --make-- or --use-- or --make and use--" \* MERGEFORMAT make and/or use the invention commensurate in scope with these claims. In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit has developed a framework of factors in In re Wands , 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors, to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue." The factors considered include, but are not limited to: (A) the breadth of the claims; (B) the nature of the invention; (C) the state of the prior art; (D) the level of one of ordinary skill in the art; (E) the level of predictability in the art; (F) the amount of direction provided by the inventor; (G) the existence of working examples; and (H) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. Breadth of the claims and nature of the invention: Claim 1 is drawn to a nucleic acid molecule having the sequence RBD-(L)n-X, wherein X is SEQ ID NO: 1. Further limitations include that the RBD is SEQ ID NO: 2 or a partial, virus-derived sequence from the RBD of Herpesviridae, Orthomyxoviridae, R habdoviridae , P aramyxoviridae , P apilomaviridae , A denoviridae, P arvoviridae , A stroviridae , R eoviridae, B unyaviridae , A rteriviridae , C aliciviridae , H epeviridae , B ornaviridae , A renaviridae , T ogaviridae , F iloviridae, R etroviridae , Flaviviridae, and C oronaviridae , as disclosed in instant claim 6 ; or Colacovirus , Decacovirus , Duvinacovirus , Luchavirus , Minacovirus , Minunacovirus , Myotacovirus , Nyctacovirus , Pedacovirus , Rhinacovirus , Setracovirus , Soracovirus , Tegacovirus , Embecovirus , Hibecovirus , Merbecovirus , Nobecovirus , Sarbecovirus , Brangacovirus , Cegacovirus , Igacovirus , Andecovirus , Buldecovirus and Herdecovirus , which are all subgenera of Coronaviridae , as required in instant claim 7. The nucleic acid molecule can be formulated with a carrier to create a vaccine composition against a virus. At a minimum, the claims encompass a vaccine composition wherein the RBD is derived from any of the disclosed viral families. However, the specification only provides sufficient disclosure of a single nucleic acid molecule that has neutralizing activity, wherein the RBD is COVID-19 (SEQ ID NO: 2) and the carrier is a porous silica particle (page 51, paragraphs 224 – 227) . Those with relevant skill in the art: The level of skill in the art is that of Ph.D. - level scientists and medical doctors (D.O. and/or M.D.). Amount of direction and existence of working examples: The instant application teaches a single working example for the selection of the mRNA nucleotide sequence and carrying it on a carrier ( pages 44 – 49; paragraphs 184 – 213 ) , which do not represent an example for the innumerable potential RBD sequences and, thus, vaccine compositions, per viral family . Paragraph 186 of the instant disclosure teaches that the nucleotide sequence of SEQ ID NO: 2, which is the RBD sequence of COVID-19 , was used for the RBD of the nucleic acid molecule. No universal RBD sequence is described that would function in a vaccine composition. The specification has only adequately described, and successfully reduced to practice, a specific nucleic acid molecule derived from COVID-19 , i.e., SEQ ID NO: 2, with an associated linker sequence (L), i.e., SEQ ID NOs: 3 or 4, and stabilization sequence (X), i.e., SEQ ID NO: 1 , immunization with which elicits IgG antibodies that have neutralizing abilities (pages 50 and 51, paragraphs 221 – 227) . Thus, the instant application offers no reasonable guidance or direction to use the claimed nucleic acid molecule with the RBD of the claimed viral families as a vaccine. State of the prior art , unpredictability in the art , and quantity of experimentation needed : It is taught by Pennington, H. N. and Lee, J., ( Lassa virus glycoprotein complex review: insights into its unique fusion machinery. Bioscience reports , 42 (2) ; Published 02/14/2022), hereby Pennington, that the Arenaviridae family is a diverse group of viruses that can be divided into two separate categories (page 1, first paragraph). It is further taught that there are no approved vaccines for the explicit treatment of an arenavirus known as Lassa virus ( LASV; page 1, second paragraph). Pennington goes on to teach that while there is a vaccine against Junín virus (JUNV), another arenavirus, it is ineffective against LASV (page 2, first paragraph). Further in the art, Tannock , G. A., Kim, H., & Xue, L. , Why are vaccines against many human viral diseases still unavailable; an historic perspective?. Journal of medical virology , 92 (2), 129–138 ; Published 09/10/2019), hereby Tannock , teaches that there are many factors that go into vaccine development and numerous viruses that, unfortunately, do not have vaccines against them (page 130, left column, first paragraph). This includes numerous viruses in the Flavivirus family, human immunodeficiency virus (HIV), which belongs in the Retrovirus family, and various others (page 130, left column, first paragraph). In terms of the coronavirus family, Zhou, Z., Qiu, Y., and Ge, X. , ( The taxonomy, host range and pathogenicity of coronaviruses and other viruses in the Nidovirales order. Animal diseases , 1 (1), 5 ; Published 04/23/2021), hereby Zhou, teaches that Coronaviridae is further divided into two subfamilies, wherein one of the subfamilies, i.e., Orthocoronavirinae , contains four genera, i.e., Alphacoronavirus , Betacoronavirus , Deltacoronavirus , and Gammacoronavirus (page 4, right column, second paragraph; page 6, left and right column). It is further taught that Alphacoronavirus , Betacoronavirus , Deltacoronavirus , and Gammacoronavirus have 14, 5, 3, and 3 subgenera, respectively, with there being 19, 14, 7, and 5 viral species, correspondingly, within the genera (page 6, left and right column). Zhou goes on to teach that coronaviruses have high genetic diversity with genomes in different genera varying, while those in the same genera are more similar (page 18, left column, third paragraph; page 21, right column, first paragraph). Page 1, left column goes on to teach that COVID-19 is caused by severe acute respiratory syndrome coronavirus 2 ( SARS-CoV-2 ) . At a minimum, the art teaches that there are some viruses in which vaccines have not been developed. The art also teaches that a vaccine developed against one virus in a viral family may not have cross-protection against another virus in the viral family. The skilled artisan would not recognize a universal RBD sequence that would provide a vaccine composition against all of the different viral families. In the instantly claimed invention, there would be undue experimentation to individually analyze every possible RBD sequence that could be employed to make a vaccine against a virus. Thus, one of skill in the art would neither expect nor predict the appropriate function of any RBD sequence of the instant claims for any virus within the viral families as broadly as claimed , especially those where vaccines have yet to be developed . Given the teachings of the art, a ny and all enablement of the claimed agents must therefore come from the instant disclosure. However, the instant disclosure only teaches a single vaccine composition that has neutralizing activities, wherein the nucleic acid molecule has a partial RBD sequence derived from SARS-CoV-2, i.e., SEQ ID NO: 2, with an associated linker sequence (L), i.e., SEQ ID NOs: 3 or 4, and stabilization sequence (X), i.e., SEQ ID NO: 1, that is carried by porous silica particles . The claims are clearly not enabled to their full scope. Moreover, claims not containing elements critical or essential to the practice of the invention, are not enabled by the disclosure. For the reasons discussed above, undue experimentation would be required to practice the claimed invention commensurate with the scope of the claims. Reasonable correlation must exist between the scope of the claims and scope of enablement set forth. It would take undue trials and errors to practice the claimed invention in view of the quantity of experimentation necessary, the limited working examples, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breadth of the claims. Conclusion: The instant disclosure is not enabling for a vaccine composition with a nucleic acid molecule having a RBD sequence derived from any viral family, but rather a nucleic acid molecule with the RBD sequence disclosed by SEQ ID NO: 2, which is drawn to SARS-CoV-2. Thus, only claims drawn to a nucleic acid molecule and vaccine composition with an RBD from SARS-CoV-2, i.e., the Coronaviridae family and Sarbecovirus subgenus, are enabled. At present, the claims are enabling for the exact nucleic acids that encode for the polypeptide that was shown to generate neutralizing antibodies, as defined in the instant specification, i.e., the sequence RBD-(L)n-X, wherein X is SEQ ID NO: 1, L is SEQ ID NOs: 3 or 4, and RBD is SEQ ID NO: 2. Claim Rejections - 35 USC § 102 17. 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. 18. Claims 1 – 3, 5, 6, and 8 are rejected under 35 U.S.C. 102 FILLIN "Insert either \“(a)(1)\” or \“(a)(2)\” or both. If paragraph (a)(2) of 35 U.S.C. 102 is applicable, use form paragraph 7.15.01.aia, 7.15.02.aia or 7.15.03.aia where applicable." \d "[ 2 ]" (a)(1) as being FILLIN "Insert either—clearly anticipated—or—anticipated—with an explanation at the end of the paragraph." \d "[ 3 ]" anticipated by FILLIN "Insert the prior art relied upon." \d "[ 4 ]" Lu, Y. and Swartz, J. R. (US 20150141616 A1; Published 05/21/2015), hereby Lu . Lu teaches a foldon in which two amino acids of the native sequence are substituted with cysteine residues and attached to a protein of interest at the N- or C-terminal to provide an intermolecular disulfide stabilized polypeptide ( abstract; page 1, paragraph 0007), as defined in instant claim 1. It is further taught that two or more polypeptides are linked together to form a continuous polypeptide chain, wherein the foldon and the protein of interest can be linked using a flexible linker peptide (page 1, paragraph 0007; page 3, paragraph 0031), as required in instant claim 1. The linker peptide may predominantly include the amino acid residues Gly, Ser, Ala, and/or Thr and be 1 – 25 amino acid residues in length, wherein linkers commonly employed are (GS) n and A(EAAAK) n A (page 4, paragraph 0042; claim 7), as disclosed in instant claim 5. It is taught that the foldon is comprised of SEQ ID NO: 1 with two amino acids substituted with cysteine in pairs, wherein one such substitution pair is A12C and K16C to yield SEQ ID NO: 6 (page 4, paragraphs 0043 and 0044; claims 1 – 3), as required in instant claim 1. While the nucleic acid sequence disclosed by instant SEQ ID NO: 1 does not have 100% sequence similarity to the nucleic acids encoded by SEQ ID NO: 6, page 5, paragraph 0051 teaches that a large number of nucleic acids may be made, due to the degeneracy of the genetic code, as long as the taught amino acid sequence does not change (see alignment result reproduced below on the top). Translation of instant SEQ ID NO: 1 reveal s that SEQ ID NO: 6 has 100% sequence similarity to the protein that is encoded by instant SEQ ID NO: 1 (see alignment result reproduced below on the bottom), as disclosed in instant claim 1. Lu goes on to teach that t he protein of interest can be of a viral source, including dsDNA viruses, (-) ssRNA viruses, and (+) ssRNA viruses, including coronaviruses center top 0 0 (page 1, paragraph 0007; page 3, paragraph 0032), with explicit examples of the influenza hemagglutinin (HA) stem (example 1, page 7 – 11, paragraphs 0080 – 0110) and head (example 2, pages 11 and 12, paragraphs 0111 – 0127) given as the protein of interest , wherein the latter is a partial sequence of an RBD, as required in instant claims 1 and 6. While Lu does not explicitly teach that the RBD has a length of 100 nucleotides to 5,000 nucleotides, it is taught that the protein of interest has more than about 10, 15, 20, 30, 40, 50, or more amino acids (page 3, paragraph 0032). A person having ordinary skill in the art would know that a codon for each amino acid is three nucleotides and so would readily anticipate that a sequence of 150 nucleotides would encode for a 50mer, as defined in instant claim 3. Altogether, it is taught that the foldon stabilizes the protein of interest, wherein a trimer structure is maintained under conditions otherwise unfavorable to retention of the quaternary structure and the linker can be added for further stabilization, if needed (page 1, paragraphs 0007 and 0019; page 4, paragraph 0041; claim 6), as defined in instant claims 1 and 2. This stabilized polypeptide is encoded by nucleic acids and may be used in the manufacture of a medication and/or formulation, i.e., a vaccine (page 2, paragraph 0020; page 5, paragraphs 0051 and 0052; page 6, paragraph 0073), as defined in instant claim 8. Claim Rejections - 35 USC § 103 1 9 . 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. 20 . The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: Determining the scope and contents of the prior art. Ascertaining the differences between the prior art and the claims at issue. Resolving the level of ordinary skill in the pertinent art. Considering objective evidence present in the application indicating obviousness or nonobviousness . 21. Claim s 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over FILLIN "Insert the prior art relied upon." \d "[ 4 ]" Lu, Y. and Swartz, J. R. (US 20150141616 A1; Published 05/21/2015), hereby Lu , in view of Lan, J., et. al., (Structure of the SARS-CoV-2 spike receptor-binding domain bound to the ACE2 receptor. Nature , 581 (7807), 215–220; Published 03/30/2020), hereby Lan, and Shrivastava , S., et. al. , ( Emergence of two distinct variants of SARS-CoV-2 and an explosive second wave of COVID-19: the experience of a tertiary care hospital in Pune, India. Archives of virology , 167 (2), 393–403 ; Published 01/09/2022), hereby Shrivastava, as evidenced by DuBois, R. M., et. al. , ( The receptor-binding domain of influenza virus hemagglutinin produced in Escherichia coli folds into its native, immunogenic structure. Journal of virology , 85 (2), 865–872 ; Published 01/15/2011), hereby DuBois . center 4348052 Lu teach es t he construction of a stabilized polypeptide with the foldon using an influenza HA head domain protein with SEQ ID NO: 10 as the protein of interest (page 11, paragraph 0116). DuBois teaches that the influenza RBD is located from residues 63 to 286 in the HA head (page 866, left column, third paragraph), wherein the influenza HA sequence taught by Lu is comprised of residues 71 to 278 of the HA head (see the alignment results as reproduced below ). However, Lu does not explicitly teach that the protein is a SARS-CoV-2 RBD, as required in instant claim 4; or that the RBD is from the genera defined in instant claim 7 . Lan teaches that the SARS-CoV-2 RBD is from residues 333 to 526 of the SARS-CoV-2 spike protein (page 216, right column, first paragraph; see also part of figure 1 as reproduced below on the top ) . Translation of instant SEQ ID NO: 2 reveals 99. 1 % sequence similarity to the sequence of the SARS-CoV-2 RBD that is taught by Lan (see alignment result reproduced below on the bottom). However, two residues, L452 and E484, are substituted with an R and Q, respectively, in the instant sequence, yielding an RBD with a double mutation of L452R/E484Q. Lan teaches that center bottom both of these residues are located in the receptor-binding motif (RBM), which is subject to sequence variation between viral species (page 216, right column, second paragraph; page 219, right column, first paragraph). It should be noted that Lan was published early in the pandemic , i.e., February 2020, and used an early lineage sequence. Nonetheless, Shrivastava teaches that the Kappa variant of SARS-CoV-2 has a characteristic double mutation of L452R/E484Q in the RBD of its spike protein , wherein Kappa was first noted as the predominant circulating strain in March 2021 (page 393, abstract; page 395, right column, second paragraph; page 396, table 1) . It is further taught by Shrivastava that the complete genome sequence of the SARS-CoV-2 spike glycoprotein comprises the nucleotide sequence of instant SEQ ID NO: 2 (see alignment results reproduced below on the left) that encodes for the Kappa variant RBD amino acid sequence (see alignment results reproduced below on the top right), wherein SARS-CoV-2 is inherently a Coronaviridae in the genus of Betacoronavirus and the subgenus of Sarbecovirus (page 394, right column, second paragraph; see details of GenBank Accession No. MW969755 as reproduced center bottom below on the bottom right), as defined in instant claim 7 . Lu, DuBois, Lan , and Shrivastava are considered to be analogous to the claimed invention because all are drawn viral proteins, particularly RBDs, and their associated sequences . Based on the prior art teachings , it would have been obvious to a person having ordinary skill in the art to prepare a vaccine formulation using the stabilized polypeptide , including the linker and stabilization sequence as taught by Lu with the protein of interest as the Kappa variant of the SARS-CoV-2 RBD, as taught by Lan and Shrivastava , instead of the influenza RBD, as evidenced by DuBois . This obviousness is mainly owed to Lu teaching the invention with Lan and Shrivastava teaching the sequence of the SARS-CoV-2 RBD that can be utilized as a substitution for the disclosed influenza RBD . Therefore, it would have been obvious to a person having ordinary skill in the art to have combined the teachings of Lu , DuBois, Lan , and Shrivastava before the effective filing date of the claimed invention with a reasonable expectation of success to develop highly potent cross-reactive therapeutic agents against diverse coronavirus species, including SARS-CoV-2 (Lan; page 219, right column, first paragraph) . All the claimed elements were known in the prior art. Known work in one field of endeavor, i.e., influenza, may prompt variations of it for use in either the same field or a different one, i.e., SARS-CoV-2, based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc. , 550 U.S. 398, 415–421, 82 USPQ2d 1385, 1395–97 (2007) and MPEP §§ 2143 F and 2143.02. 2 2 . Claims 9 – 14 are rejected under 35 U.S.C. 103 as being unpatentable over FILLIN "Insert the prior art relied upon." \d "[ 4 ]" Lu, Y. and Swartz, J. R. (US 20150141616 A1; Published 05/21/2015), hereby Lu , in view of FILLIN "Insert the additional prior art reference(s) relied upon for the obviousness rejection." \d "[ 4 ]" Won, C. H., Kim, J. H., and Kim, J. (US 20220040217 A1; Published 02/10/2022), hereby Won . It should be noted that the United States Publication referenced here in as Won is from a continuation of PCT/KR2020/002648 that was published on 08/27/2020 as WO 2020/171680 A1 and is cited in Applicant’s IDS on 05/14/2025 as Foreign Patent Document Cite No. 1. Lu teaches that vaccine formulations suitable for delivery include liposomes and virus-like particles (VLPs), as required in instant claim 9. However, Lu does not the explicit usage of porous silica particles and their associated properties, as required in instant claims 9 – 14. Won teaches RNA delivery efficiency is known to be very low when using a liposome as a carrier, wherein porous silica particles provide sufficient support of RNA and, thus, delivery (page 6, paragraph 0113), as disclosed in instant claims 9 and 10. The average pore diameter of the porous silica particles is taught to be 7 to 25 nm (abstract; page 6, paragraphs 0110 and 0120; claims 11 and 23), as defined in instant claim 11. It is further taught that the inside of the pores is positively charged to balance the negative charge of the contained RNA (abstract; page 6, paragraphs 0110 and 0114 – 0116), as defined in instant claim 1 2 . Won goes on to teach that the porous silica particles are biodegradable particles that are biodegraded in the body to release RNA when administered (page 6, paragraph 0122; page 7, paragraph 0128), as disclosed in instant claim 13. Page 6, paragraph 0118 and claim 8 go on to teach that the weight ratio of the porous silica particles to RNA is 1:5-20, as disclosed in instant claim 14. T he range of the pore diameter in claim 11 and weight ratio in cl