CTNF 18/974,619 CTNF 98285 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. Disposition of Claims Claims 1-18 are pending and will be examined on their merits. Examiner’s Note All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US 2025/0108108 A1, Published 03 April 2025. Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice. Information Disclosure Statement 06-49-06 AIA 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." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. 06-49 AIA The information disclosure statement filed 28 January 2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because it contains at least one duplicated reference. Specifically, two copies of the Grifoni et al. NPL reference were provided. This reference has only been considered once . It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a). 06-49-07 The information disclosure statement filed 28 January 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Specifically, no copy of the NPL entitled “GenBank Accession No. M10298” was provided. It has been placed in the application file, but the information referred to therein has not been considered. The information disclosure statements (IDSes) submitted on 28 January 2025, 14 July 2025, and 28 November 2025 have been considered by the examiner. Any individual references with strikethroughs, however, have not been considered. Specification 06-16 AIA Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. The abstract of the disclosure is objected to because it contains legal phraseology, specifically in the form of “e.g.”, which stands for “exempli gratia”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). 07-29 AIA The disclosure is objected to because of the following informalities: In Paragraphs 0026, 0041-0043, 0094-0095, and 0112, at least, sequences are described by reference to GenBank Accession Nos., which are subject to change, rather than to sequences set forth in the specification. This is an improper incorporation by reference, since the information required to describe and enable the required sequences is found in the NCBI database, extraneous to the application. Furthermore, since the NCBI sequences are not irrevocably fixed but are corrected and updated as additional sequence information becomes available, the NCBI accession numbers may refer to sequences which change after the application filing date. Thus, the disclosure is objected to for this improper incorporation by reference . Appropriate correction is required. 06-31 AIA 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 07-29-01 AIA Claim s 2-14 and 16-18 are objected to because of the following informalities: in Claims 2-13, Line 1 of each respective claim should say “The hybrid Coronavirus-Influenza vaccine composition of” instead of “The composition of”. In Claims 16-18, they should say “The Influenza vaccine composition of” instead of “The composition of”. In Claim 11, it is suggested that it say “SEQ ID NO s :” instead of “SEQ ID NO:”. In Claim 12, it is suggested that it say “CXCL10, and CXCL11” instead of “CXCL10, CXCL11”. In Claim 14, it is suggested that it say “NSP3, and NSP14, or a combination thereof” instead of “NSP3, NSP14, or combination thereof” . Appropriate correction is required. 07-29-01 AIA Claim 14 is objected to because of the following informalities: the definition of the abbreviation “NSP” is not provided. For clarity, it is requested that the first recitation of an abbreviation within a claim set be preceded by its full-length name (i.e.,… non-structural protein 2 (NSP2)...) . Appropriate correction is required. Claim Rejections - 35 USC § 112(b); Second Paragraph 07-30-02 AIA 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. Claims 2, 8, and 16, and dependent claims 3-4, 9, and 17 thereof, 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. Regarding Claims 2, 8, and 16, they all recite the limitation “highly conserved”. While Paragraph 0077 of the instant Specification attempts to define this term, it fails to provide a specific definition. As such, it is unclear what is included or excluded by this limitation and this lack of clarity renders the claims indefinite. It is suggested that the claims be amended by removing the claim limitation or replacing it with a term properly defined by the instant Specification, but Applicant is free to amend the claims as they deem necessary. Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 2, 8, and 16 are rejected on the grounds of being indefinite. Claims 3-4, 9, and 17 are also rejected, since they depend on Claims 2, 8, and 16 but do not remedy the deficiencies of Claims 2, 8, and 16. Claims 3, and dependent claim 4 thereof, 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. Regarding Claim 3, it recites the limitation “future outbreaks”. This limitation renders the claim indefinite because it is unclear how one of ordinary skill can develop a conserved portion of a Coronavirus spike protein that is derived from a coronavirus of a future outbreak. It is suggested that the claim be amended by removing the claim limitation, but Applicant is free to amend the claim as they deem necessary. Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 3 is rejected on the grounds of being indefinite. Claim 4 is also rejected, since it depends on Claim 3 but does not remedy the deficiencies of Claim 3. 07-34-01 Claims 3-4 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. Regarding Claims 3-4, they both recite the limitation “in current circulation”. This limitation renders the claims indefinite because it is unclear what the metes and bounds of “in current circulation” are and the instant specification does not provide a definition for this phrase. It is suggested that the claims be amended by removing this claim limitation, but Applicant is free to amend the claims as they deem necessary. Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 3-4 are rejected on the grounds of being indefinite. 07-34-01 Claim 4 is 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. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation “B.1.1.529-Omicron”, and the claim also recites (BA.1), which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. This is also the case for the limitations reciting other sub-variants. Specifically, “B.1.1.529” refers to the original Omicron variant, while “BA.1”, “BA.2”, “BA.3”, “BA.4”, and “BA.5” refer to specific sub-variants of the original Omicron variant. It is suggested that the claim be amended to recite these separate limitations as Markush groups wherein the recited limitations are claimed in the alternative or that the claim be amended to recite only (1) of the possible limitations, but Applicant is free to amend the claim as they deem necessary. Additionally, “BA.1” is recited twice. As such, it appears this embodiment has been duplicated in the claim, rendering the claim indefinite. It is suggested that one recitation of this limitation be deleted, but Applicant is free to amend the claim as they deem necessary. Furthermore, the use of parentheses to recite the sub-variant names also renders the claim indefinite, as it is unclear if the recited limitations within the parentheses are required elements of the claim. It is suggested that the parentheses be deleted, but Applicant is free to amend the claim as they deem necessary. Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 4 is rejected on the grounds of being indefinite. 07-34-01 Claims 9 and 16-18 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. Claims 9 and 16-18 recite the limitation "the portion" in Line 1 of each respective claim. There is insufficient antecedent basis for this limitation in these claims, rendering them indefinite. Claims 8 and 15, which Claims 9 and 16-18 depend on, respectively, recite the limitation of “the conserved portion” or “a conserved portion”, respectively. It is suggested that Claims 9 and 16-18 be amended to recite “the conserved portion”, but Applicant is free to amend the claims as they deem necessary. Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 9 and 16-18 are rejected on the grounds of being indefinite. 07-34-01 Claims 3-4, 7, 9-14, and 17-18 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. Regarding Claims 3-4, 7, 9-14, and 17-18, they each list species but they do not word the listing of said species in the respective Markush grouping as being limited to just the options recited. As such, it is unclear if these claims encompass other options or species which are not explicitly recited and this lack of clarity renders the claims indefinite. It is suggested that the claims be amended by adding the phrase “selected from the group consisting of”, so Claim 7, for example, instead recites “wherein the conserved portion of the Coronavirus spike (S) protein is encoded by a sequence selected from the group consisting of SEQ ID NOs: 1, 3, and 5-7”, or similar language, but Applicant is free to amend the claims as they deem necessary. Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 3-4, 7, 9-14, and 17-18 are rejected on the grounds of being indefinite. 07-34-01 Claims 9 and 17 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. Regarding Claims 9 and 17, they recite the limitation of “MW798370.1”. This does not correspond to an Influenza HA protein sequence. Instead it corresponds to a sequence from a Penicillium sp. isolate (see attached). Also, they both recite the limitation of “MT1055640.1”. No hits are returned when that supposed accession number is searched on the NCBI website (see attached). As such, it is unclear what other embodiments were meant to be recited in their respective places, rendering the claims indefinite. It is suggested that the erroneous GenBank Accession Nos. be deleted, but Applicant is free to amend the claims as they deem necessary. Additionally, Claims 9 and 17 recite several GenBank accession numbers, which are not irrevocably fixed but are corrected and updated as additional sequence information becomes available. This means that the NCBI accession numbers may refer to sequences which change after the application filing date. Therefore, the recitation of each GenBank accession number is indefinite. It is suggested that Applicants remove all recitations to these accession numbers in the claims. Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 9 and 17 are rejected on the grounds of being indefinite. Claims 9 and 17 recite several Genbank accession numbers, which are not irrevocably fixed but are corrected and updated as additional sequence information becomes available, the NCBI accession numbers may refer to sequences which change after the application filing date. Therefore, the recitation of each Genbank accession number is indefinite. It is suggested that applicants remove all recitations to these accession numbers in the claims. 07-30-03-h AIA Claim Interpretation The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. Claim Rejections - 35 USC § 112(a); First Paragraph 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 s 1-18 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 an immunogenic composition comprising at least a conserved portion of a Coronavirus spike protein and at least a conserved portion of at least on Influenza HA protein or a sequence encoding said proteins , does not reasonably provide enablement for a vaccine composition comprising at least a conserved portion of a Coronavirus spike protein and at least a conserved portion of at least on Influenza HA protein or a sequence encoding said proteins . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). See also MPEP § 2164.01(a) and § 2164.04. Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows: Nature of the invention/Breadth of the claims . The claims are drawn to a hybrid Coronavirus-influenza vaccine composition, the composition comprising, or comprising a sequence encoding, at least a conserved portion of a Coronavirus spike (S) protein and at least a conserved portion of at least one Influenza hemagglutinin (HA) protein; a hybrid Coronavirus-Influenza vaccine composition, the composition comprising, or comprising a sequence encoding at least a portion of at least one Coronavirus protein, the Coronavirus protein being selected from a spike protein, a nucleocapsid protein, NSP2, NSP3, NSP14, or a combination thereof and at least a portion of at least one Influenza HA protein; and Influenza vaccine composition, the composition comprising, or comprising a sequence encoding: at least a conserved portion of at least one influenza hemagglutinin (HA) protein. Paragraph 0070 states in part that “the term ‘immunological response to a composition or vaccine refers to the development in the host of a cellular and/or antibody-mediated immune response to a composition or vaccine of interest”. State of the prior art/Predictability of the art . Reasonable guidance with respect to preventing any viral infection relies on quantitative analysis from defined populations that have been successfully pre-screened and are predisposed to particular types of viruses. The essential element towards the validation of a preventive therapeutic is the ability to test the drug on subjects monitored in advance of clinical infection and link those results with subsequent histological confirmation of the presence or absence of disease. This irrefutable link between antecedent drug and subsequent knowledge of the prevention of the disease is the essence of a valid preventive agent. Further, a preventive administration also must assume that the therapeutic will be safe and tolerable for anyone susceptible to the disease. Therefore, Applicant may provide data showing prevention in vivo . As stated in Cross v. Iizuka, 753 F.2d 1040, 1050, 224 USPQ 739, 747 (Fed. Cir. 1985): [B]ased upon the relevant evidence as a whole, there is a reasonable correlation between the disclosed in vitro utility and an in vivo activity, and therefore a rigorous correlation is not necessary where the disclosure of pharmacological activity is reasonable based upon the probative evidence. (Citations omitted.) Therefore, in the absence of the in vivo data above, Applicant may also provide evidence of pharmacological activity that would reasonably correlate with prevention of infection. In the case of virus vaccines, a reasonable nexus exists between neutralizing antibody generation and prevention of infection. Thus, a showing that an antigen within the recited immunogen scope can produce such antibodies would support enablement for use of said antigen in a vaccine and/or methods of preventing infection therewith of the virus comprising said antigen. Burton (Nature Reviews Immunology, Vol. 2, Pg. 706-713, 2002) teaches neutralizing antibodies are crucial for vaccine-mediated protection against viral diseases (Abstract). Figure 1 divides antiviral activities of antibodies into two groups: activities against free virus and activities against infected cells. Actual block of infection (prevention of infection) is taught to be the role of neutralizing antibodies (Figure 1). Nonneutralizing antibodies thus cannot prevent infection, only treat an infection. Adding to the unpredictability is the fact that not just any epitope of a target antigen/virus will lead to antibody generation, let alone that of neutralizing antibodies. Riddell (Journal of Virology, Vol. 74, No. 17, Pg. 8011-8017, 2000) at the abstract teaches patient sera reacts with some but not all B-cell epitopes on ORF7.1 protein. Thus, not just any epitope/antigen/immunogen will contribute to patient immunity against a virus. Sugiyama (Journal of Virology, Vol. 76, No. 4, Pg. 1691-1696, 2002) supports this by teaching in their abstract that even amongst known epitopes that lead to neutralizing antibodies in some species, another subject’s immune reaction will not necessarily generate antibodies against all said epitopes. Burton (PNAS, Vol. 108, No. 27, Pg. 11181-11186, 2011) teaches three anti-HIV antibodies. Antibodies b12 and b6 bind CD4 binding sites while F240 binds gp41 (Abstract). All were tested for prevention of SHIV transmission to macaques (Abstract). While the two anti-gp120 antibodies have similar binding properties, b12 is strongly neutralizing and b6 is not (Abstract). F240 is nonneutralizing (Abstract). Compared to controls, the protection by b12 achieved statistical significance while no such protection was seen for either b6 or F240 (Abstract). Thus, the work of Burton supports the conclusion that neutralizing antibodies are required for prevention and so a functional vaccine should produce such. It also supports the idea that not just any peptide on protein may generate neutralizing antibodies that protect as evidenced by b12 and b6 performance above. Data are clearly required to calm the concerns of the prior art and make methods of viral infection prevention and vaccine products predictable. Taken together, it is clear from the prior art that a PHOSITA cannot predict the preventative power of any immunogen. They must be shown data that supports such a conclusion. Without demonstration of neutralizing antibody production, for example, in the target population with the specific immunogen, no practitioner in this art would see any given immunogen as a functional, predictable prophylactic agent. Working examples . No working example of a vaccine composition is disclosed in the specification. All examples provided are hypothetical or prophetic in nature. Guidance in the specification . The specification provides guidance towards an immunogenic composition comprising at least a conserved portion of a Coronavirus spike protein and an Influenza HA protein as well as an immunogenic composition comprising an Influenza HA protein. The instant specification does not provide any actual data, either in vitro or in vivo , regarding the immunogenicity of either composition, however. Amount of experimentation necessary . Additional research is required in order to determine how effective the claimed composition would be at generating neutralizing antibodies against either or both types of viruses, preventing infection with any Coronavirus or Influenza A or B virus strains, and acting as part of a vaccine. For the reasons discussed above, it would require undue experimentation for one skilled in the art to use the claimed products . Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. 07-15 AIA Claim s 1-3, 5-6, 8, and 13-16 are rejected under 35 U.S.C. 102( a)(1) and 102(a)(2 ) as being anticipated by Broeker (US 2009/0130146 A1, Published 21 May 2009) . Broeker teaches a combination composition comprising multiple antigens from different microorganisms or nucleic acids encoding said antigens, including bacteria and viruses (see Abstract; Paragraph 0057), wherein the viral antigens can be derived from a Coronavirus, such as SARS-CoV-1, or Orthomyxoviruses, such as Influenza A, B, and C (see Paragraphs 0151, 0136-0137). Broeker teaches that said antigens are conserved across multiple serotypes or isolates (see Paragraph 0135) and wherein the Coronavirus antigens are derived from the Spike protein (see Paragraph 0151), wherein the Influenza antigens are derived from the HA protein (see Paragraph 0136), and wherein the composition comprises one or more antigens derived from a pathogen which causes respiratory disease, such as a Coronavirus, like SARS-CoV-1, which is a Coronavirus that has caused a previous human outbreak, or an Orthomyxovirus, such as Influenza (see Paragraph 0166), which reads on instant Claims 1-3, 5-6, 8, and 14-16 . Additionally, Broeker teaches combination compositions further comprising adjuvants such as interleukins, including IL-2 and IL-7 (see Paragraph 0092), which reads on instant Claim 13 . For at least these reasons, Broeker teaches the limitations of instant Claims 1-3, 5-6, 8, and 13-16 and anticipates the invention encompassed by said claims . 07-15 AIA Claim s 15-17 are rejected under 35 U.S.C. 102( a)(1) and 102(a)(2 ) as being anticipated by Garcia-Sastre et al. (US 2014/0328875 A1, Published 06 November 2014) . Garcia-Sastre et al. teach compositions comprising chimeric Influenza HA polypeptides (see Abstract), wherein the chimeric HA polypeptides comprise a conserved HA stem or stalk domain (see Paragraphs 0009, 0090-0092; Figures 2 and 4), which reads on instant Claims 15-16 . Garcia-Sastre et al. also teach compositions comprising chimeric Influenza HA polypeptides, wherein the stem or stalk domain is derived from an Influenza B virus, such as Influenza B strain Hong Kong/8/73, whose HA antigen corresponds to GenBank Accession No. M10298.1 (see Paragraph 0167), which reads on instant Claim 17 . For at least these reasons, Garcia-Sastre et al. teach the limitations of instant Claims 15-17 and anticipate the invention encompassed by said claims . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-22-aia AIA Claim s 4, 9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Broeker ( supra ) as applied to claim s 1-3, 5-6, 8, and 13-14 above, and further in view of Garcia-Sastre et al. ( supra ), Fraser et al. (US 2012/0070493 A1, Published 22 March 2012), and Scholler et al. (US 2012/0258126 A1, Published 11 October 2012) (cited by Applicant on IDS filed on 28 November 2025) . As noted above, Broeker teaches a combination composition comprising multiple antigens from different microorganisms or nucleic acids encoding said antigens, including bacteria and viruses (see Abstract; Paragraph 0057), wherein the viral antigens can be derived from a Coronavirus, such as SARS-CoV-1, or Orthomyxoviruses, such as Influenza A, B, and C (see Paragraphs 0151, 0136-0137). Broeker teaches that said antigens are conserved across multiple serotypes or isolates (see Paragraph 0135) and wherein the Coronavirus antigens are derived from the Spike protein (see Paragraph 0151), wherein the Influenza antigens are derived from the HA protein (see Paragraph 0136), and wherein the composition comprises one or more antigens derived from a pathogen which causes respiratory disease, such as a Coronavirus, such as SARS-CoV-1, or an Orthomyxovirus, such as Influenza (see Paragraph 0166). Additionally, Broeker teaches combination compositions further comprising adjuvants such as interleukins, including IL-2 and IL-7 (see Paragraph 0092). Broeker fails to teach combination compositions comprising Coronavirus antigens derived from the Spike protein of any SARS-CoV-2 variants or common cold Coronaviruses or combination compositions comprising Influenza antigens derived from the HA protein of specific Influenza strains. Broeker also fails to teach combination compositions further comprising T cell attracting chemokines. Garcia-Sastre et al. teach compositions comprising chimeric Influenza HA polypeptides (see Abstract), wherein the chimeric HA polypeptides comprise a conserved HA stem or stalk domain (see Paragraphs 0009, 0090-0092; Figures 2 and 4). Garcia-Sastre et al. also teach compositions comprising chimeric Influenza HA polypeptides, wherein the stem or stalk domain is derived from an Influenza B virus strain, such as M10298.1 (see Paragraph 0167), which reads on instant Claim 9 . Fraser et al. teach compositions comprising MHC II binding peptides wherein the peptides are obtained or derived from an infectious agent (see Abstract), wherein the infectious agent is a virus, such as a Coronavirus or an Influenza virus (see Paragraphs 0009-0014), wherein the Coronavirus is SARS-CoV-1 or a common cold Coronavirus (see Paragraph 0124; Table 1), which reads on instant Claim 4 . Scholler et al. teach immunogenic compositions against Coronavirus infection or Influenza virus infection (see Paragraphs 0345-0346, 2583, 2588) further comprising additionally immunologically active molecules (see Paragraph 0190), including chemokines, such as CCL5, CXCL9, CXCL10, and CXCL11 (see Paragraph 0216), which can be used to enhance the immunogenicity of the composition (see Paragraphs 0190-0192), which reads on instant Claim 12 . A person having ordinary skill in the art would have been motivated to combine the teachings of Broeker, Garcia-Sastre et al., Fraser et al., and Scholler et al. in order to generate a composition comprising both Coronavirus and Influenza antigens. Modifying the immunogenic combination composition of Broeker with the chemokines of Scholler et al. would enhance the therapeutic effectiveness of the immunogenic composition and make for a more effective treatment. Modifying the immunogenic combination composition of Broeker with specific antigens, such as the common cold Coronavirus or Influenza B antigens of Fraser et al. or Garcia-Sastre et al., respectively, would have enabled for the generation of compositions which would elicit immune responses against specific antigens. The combination of these teachings renders the instantly claimed inventions obvious. Such modifications, combining prior art elements according to known methods in order to yield predictable results, would have had a reasonable expectation of success and arrived at the claimed invention prior to the effective filing date of the instant application. For at least these reasons, instant Claims 4, 9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over the prior art . Double Patenting 08-33 AIA 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer. 08-37 AIA Claim s 1-6, 8-9, and 12-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 31-35, 37-38, 41, 44-45, 48, 50-52, 58-60, and 78 of copending Application No. 18/872,496 (US 2025/0360201 A1, Published 27 November 2025) in view of Broeker ( supra ), Garcia-Sastre et al. ( supra ), and Fraser et al. ( supra ). Both claim sets are drawn to compositions comprising a conserved Coronavirus Spike protein or at least one Coronavirus Spike protein selected from Spike protein, Nucleocapsid protein or Nucleoprotein, NSP2, NSP3, and NSP14, or a combination thereof. Instant Claim 14 recites a composition comprising at least one Coronavirus Spike protein selected from Spike protein, Nucleocapsid protein or Nucleoprotein, NSP2, NSP3, and NSP14, or a combination thereof, which encompasses all of the combinations recited in reference Claims 31-35, 37-38, 41, 44-45, 48, and 50-52. Reference Claim 78 reads on compositions comprising only one Coronavirus protein, such as a conserved Coronavirus Spike protein, as is recited in instant Claims 1 and 14. While instant Claim 1 does not recite additional Coronavirus proteins, the use of the term “comprising” means that it reads on compositions comprising the Spike protein and other Coronavirus proteins, as is recited in reference Claims 31-35, 37-38, 41, 44-45, 48, and 50-52. Both claim sets are also drawn to compositions further comprising a T cell attracting chemokine, such as CCL5, CXCL9, CXCL10, or CXCL11, or a combination thereof, or further comprising a composition that promotes T cell proliferation and T-cell memory, such as IL-7, IL-2, or IL-15. The main differences between the instant claims and the reference claims are that the instant claims are drawn to a hybrid composition comprising both Influenza virus and Coronavirus antigens, wherein the Coronavirus can be a common cold Coronavirus or a variant of SARS-CoV-2, while the reference claims are not drawn to specific Coronaviruses and do not recite a combination composition comprising non-Coronavirus antigens. The reference claims are also drawn to a composition comprising at least two conserved Coronavirus antigens. The teachings of Broeker, Garcia-Sastre et al., and Fraser et al. have been summarized above. A person having ordinary skill in the art would have been motivated to modify the teachings of the reference claims with those of Broeker, Garcia-Sastre et al., and Fraser et al. in order to develop a combination vaccine that protects against different virus families, such as Coronaviruses and Influenza viruses, and specific viruses within those families. Broeker teaches compositions comprising antigens from viral pathogens which cause respiratory disease, such as Coronavirus and Influenza virus, while Garcia-Sastre et al. teach compositions comprising chimeric or heterologous HA polypeptides to protect against multiple types of Influenza virus. Additionally, the principle of immunogenic compositions comprising antigens from multiple types of infectious agents, such as Influenza virus vaccines or the MMR vaccine, is well-known in the art. As such, it would have been obvious to a skilled artisan to apply this principle to the reference composition so that it could protect against other types of respiratory pathogens, such as Coronaviruses, in addition to Influenza viruses. A combination composition such as this would have provided a faster and more economical way of immunizing subjects against multiple pathogens at the same time. Such modifications, combining prior art elements with the teachings of the reference claims according to known methods in order to yield predictable results, would have had a reasonable expectation of success and arrived at the claimed instant invention. For at least these reasons, instant Claims 1-6, 8-9, and 12-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-35, 37-38, 41, 44-45, 48, 50-52, 58-60, and 78 of the reference application in view of Broeker, Garcia-Sastre et al., and Fraser et al . This is a provisional nonstatutory double patenting rejection. Conclusion No claims are allowed. 07-96 The prior art made of record, but not relied upon, and considered pertinent to applicant's disclosure is listed below: Rasochova et al. (US 2007/0041999 A1, Published 22 February 2007) Rasochova et al. teach compositions comprising multivalent virus-like particles containing different antigenic peptides, wherein the peptides are derived from Coronaviruses or Influenza viruses. This reference has not been considered, as rejection would have been redundant to those set forth above. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAREY A STUART whose telephone number is (703)756-4668. The examiner can normally be reached Monday - Friday, 7:30 AM - 4:30 PM EST. 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, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /CAREY ALEXANDER STUART/Examiner, Art Unit 1671 /BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671 Application/Control Number: 18/974,619 Page 2 Art Unit: 1671 Application/Control Number: 18/974,619 Page 3 Art Unit: 1671 Application/Control Number: 18/974,619 Page 4 Art Unit: 1671 Application/Control Number: 18/974,619 Page 5 Art Unit: 1671 Application/Control Number: 18/974,619 Page 6 Art Unit: 1671 Application/Control Number: 18/974,619 Page 7 Art Unit: 1671 Application/Control Number: 18/974,619 Page 8 Art Unit: 1671 Application/Control Number: 18/974,619 Page 9 Art Unit: 1671 Application/Control Number: 18/974,619 Page 10 Art Unit: 1671 Application/Control Number: 18/974,619 Page 11 Art Unit: 1671 Application/Control Number: 18/974,619 Page 12 Art Unit: 1671 Application/Control Number: 18/974,619 Page 13 Art Unit: 1671 Application/Control Number: 18/974,619 Page 14 Art Unit: 1671 Application/Control Number: 18/974,619 Page 15 Art Unit: 1671 Application/Control Number: 18/974,619 Page 16 Art Unit: 1671 Application/Control Number: 18/974,619 Page 17 Art Unit: 1671 Application/Control Number: 18/974,619 Page 18 Art Unit: 1671 Application/Control Number: 18/974,619 Page 19 Art Unit: 1671 Application/Control Number: 18/974,619 Page 20 Art Unit: 1671 Application/Control Number: 18/974,619 Page 21 Art Unit: 1671
Prosecution Insights