Prosecution Insights
Last updated: October 21, 2026
Application No. 18/374,118

INTRANASAL VACCINE COMPOSITION AND METHOD FOR BOOSTING USING THE SAME

Non-Final OA §102§103§112§DOUBLEPATENT
Filed
Sep 28, 2023
Priority
Jun 28, 2023 — provisional 63/523,876
Examiner
BELLECOURT, MICHAEL JOHN ALLEN
Art Unit
1671
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Advagene Biopharma Co. Ltd.
OA Round
1 (Non-Final)
Grant Probability
Favorable
1-2
OA Rounds

Examiner Intelligence

Grants only 0% of cases
0%
Career Allowance Rate
0 granted / 0 resolved
-60.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
Avg Prosecution
15 currently pending
Career history
4
Total Applications
across all art units
This examiner has no resolved cases yet (career too new); statute-level performance unavailable. The Grant Probability card shows Tech Center averages instead.

Office Action

§102 §103 §112 §DOUBLEPATENT
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Election/Restrictions Applicant's election with traverse in the reply filed on 07/30/2026 is acknowledged. Applicant elects Invention I (claims 1–12) and the following species: Seasonal influenza virus and its associated antigen hemagglutinin (HA), Prior priming against seasonal influenza, Prior priming via intramuscular vaccination, Enhancement of serum IgG immunoglobulin isotype levels through intranasal boosting, and Enhancement of IFN-γ levels through intranasal boosting. The traversal is on the grounds that although the inventions are patently distinct, they are related and that examination of Invention II and of all enumerated species would not place a serious search and/or examination burden on the Office. This is not found persuasive because Applicant has provided an unsubstantiated opinion disagreeing with the degree of search and/or examining burden without offering a rebuttal of the rationale of the examiner as communicated in the Office action of 03/12/2026. Applicant is further reminded that the instant case is a U.S. national application filed under 35 USC 111(a), and so common features between claims do not obviate a restriction requirement. The requirement is still deemed proper and is therefore made FINAL. Claims 13–19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 3–5 are likewise withdrawn from further consideration, as being drawn to nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/30/2026. Claim Status Claims 3–5 and 13–19 are withdrawn. Claims 1–2 and 6–12 are under examination on the merits. Priority The U.S. effective filing date of the claims under examination above is set at 06/28/2023. Information Disclosure Statement 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. The information disclosure statements (IDSs) submitted on 09/28/2023, 06/28/2024, 04/04/2025, and 11/12/2025, and 08/03/2026 are being considered by the examiner. Specification The use of the following terms, which are trade names or marks used in commerce, has been noted in this application: THERMO FISHER SCIENTIFIC: p. 11, para. [0047], line 6 EXPICHO: p. 11, para. [0047], line 8 GE: p. 11, para. [0047], line 9 KPL: p. 12, para. [0052], line 3 MIRUS BIO: p. 12, para. [0054], line 15 TECAN: p. 13, para. [0056], line 1 The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. 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. Claim Interpretation Regarding claim 6, “seasonal influenza” is interpreted to mean the annual variations in active influenza virus strains, caused by the virus’s rapid rate of antigenic drift, which leads to the emergence of new viral strains. These patterns, which lead to seasonal epidemics and/or pandemics, lead to the development of new multivalent influenza virus vaccine formulations comprising a distinct set of antigens derived from the strains that are predicted to be epidemic or pandemic in that given year. Regarding claim 7, according to p. 8, para. [0034] of the instant specification, “LTh(αK)” refers to a variant E. coli labile toxin (LT) with a S61K point mutation. Prior art demonstrates that this point mutation is on subunit A of the LT holoenzyme (Hsu et al., US 2008/0102078 A1, published 05/01/2008; p. 1, para. [0005], lines 4–7). Regarding claims 10–11, “wherein the intranasal booster enhances…” is interpreted to indicate the intended result of a process step positively recited and does not give meaning and purpose to the manipulative steps. Claim Rejections - 35 USC § 112(b) - Indefiniteness 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 1–2 and 6–12 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 1, the phrase “detoxified Escherichia coli labile toxin (LT)” renders the claim indefinite. Although the Instant Specification clearly defines LTh(αK) as recited in claim 7, it is unclear from the claim language how the broader LT genus has been rendered non-toxic for use as a vaccine adjuvant; i.e., whether the LTs of claim 1 harbor mutations, have been denatured, or have been chemically modified. The presence of multiple structural interpretations renders the claims indefinite. See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008): “[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under [35 U.S.C. 112(b)], as indefinite.” Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1–2 and 8–12 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by O’Hagan (US 2003/0072764 A1, published 04/17/2003). Regarding claims 1–2 and 8–10, O’Hagan teaches parenteral prime-mucosal boost vaccination methods of one or more antigens (p. 6, para [0061], lines 1–3) with multiple administrations of the intranasal booster (p. 11, para. [0101], lines 6–12). In one example, they specify a vaccination schedule comprising intramuscular priming and multiple intranasal boosts that led to increases in serum IgG levels (p. 18, para. [0163], lines 1–3; Table 4; and Figure 2). They teach that particularly useful embodiments preferably comprise therapeutically effective does (p. 16, para. [0153]) of antigens, specifying that polypeptide agents derived from pathogens that infect or are transmitted through mucosal surfaces are particularly useful (p. 6, para [0061], lines 17–20). They further teach that the mucosal administration further comprises the use of a mucosal adjuvant, and describe the E. coli heat-labile enterotoxin (LT), or detoxified mutants thereof, as one such example (p. 3, para. [0023], lines 8–11). O’Hagan further teaches the influenza virus as an example of a virus for which their invention would be particularly useful. They specifically teach influenza envelope glycoprotein HA as being of particular interest as immunogens (p. 9, para. [0082], lines 1–5). Finally, O’Hagan also recites antigens from viruses of family Coronaviridae as being of use in their method (p. 9, para [0083], lines 1–3 and 16). Claims 10–12 recite whereby or wherein clauses that are intended results of the step(s) of claim 1 and are thus not given patentable weight, The court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “’whereby’ clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. Even if claims 10–12 were given weight, the recited enhancements would necessarily occur from the anticipated method. Further, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of anticipation has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As described supra, O’Hagan teaches a vaccination schedule comprising intramuscular priming and multiple intranasal boosts that led to increases in serum IgG levels (p. 18, para. [0163], lines 1–3; Table 4; and Figure 2). Therefore, the substantially identical vaccine used in the method of O’Hagan anticipates the intended results of claim 10 by way of its inseparable chemical properties. O’Hagan clearly anticipates the claims above which are rejected here. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claims 1–2, 6, and 8–12 are rejected under 35 U.S.C. 103 as being unpatentable over O’Hagan (US 2003/0072764 A1, published 04/17/2003) in view of Schouten et al. (US 2012/0219586 A1, published 08/30/2012, hereinafter “Schouten”). Regarding claims 1–2 and 8–10, as described supra (Claim Rejections - 35 USC § 102), O’Hagan teaches parenteral prime-mucosal boost vaccination methods of one or more antigens (p. 6, para [0061], lines 1–3) with multiple administrations of the intranasal booster (p. 11, para. [0101], lines 6–12). In one example, they specify a vaccination schedule comprising intramuscular priming and multiple intranasal boosts that led to increases in serum IgG levels (p. 18, para. [0163], lines 1–3; Table 4; and Figure 2). They teach that particularly useful embodiments preferably comprise therapeutically effective does (p. 16, para. [0153]) of antigens, specifying that polypeptide agents derived from pathogens that infect or are transmitted through mucosal surfaces are particularly useful (p. 6, para [0061], lines 17–20). They further teach that the mucosal administration further comprises the use of a mucosal adjuvant, and describe the E. coli heat-labile enterotoxin (LT), or detoxified mutants thereof, as one such example (p. 3, para. [0023], lines 8–11). Finally, O’Hagan further teaches the influenza virus as an example of a virus for which their invention would be particularly useful. They specifically teach influenza envelope glycoprotein HA as being of particular interest as immunogens (p. 9, para. [0082], lines 1–5). O’Hagan also recites antigens from viruses of family Coronaviridae as being of use in their method (p. 9, para [0083], lines 1–3 and 16). Although O’Hagan teaches the use of multiple antigens, as is standard practice in formulating seasonal influenza virus vaccines, they do not specifically teach a method of vaccination against seasonal influenza. Schouten teaches adjuvanted vaccine formulations; and in particular vaccines against influenza that can mount a mucosal immune response upon either intranasal or intramuscular administration (Abstract and p. 1, para [0001]). They teach that influenza vaccines are prepared based on predictions of expected strains of epidemic of the next season (p. 1, para. [0002], lines 5–6), and that these vaccines are typically parenteral in nature (p. 1, para. [0002], lines 6–8). They further teach that a vaccine formulation comprising influenza antigens from at least two influenza virus strains, at least one strain of which is associated with the potential for pandemic outbreak (p. 4, para. [0025]), as is typical of the season-to-season changes associated with influenza vaccines (p. 4, para [0024]). Schouten teaches inactivated peptidoglycan particles from Gram-positive bacteria as an adjuvant (p. 2, para [0007], lines 1–3) but additionally discloses the historical use of the E. coli heat-labile toxin as a successful adjuvant in intranasal influenza vaccines (p. 1, para. [0003], lines 27–32). Given that the prevalent strains of influenza vary season-to-season, a person having ordinary skill in the art at the time of filing would have been motivated to produce new influenza virus vaccine formulations on an annual basis in order to confer meaningful seasonal immunity to subjects receiving said vaccine. It would therefore have been prima facie obvious to adapt O’Hagan’s multivalent mucosal booster vaccine by integrating multiple antigens from multiple influenza virus strains as taught by Schouten to create a multivalent mucosal, adjuvanted booster vaccine against seasonal and/or endemic influenza viruses. Such would provide the advantage of a more effective influenza vaccine predictably. With respect to the wherein clauses of claims 10–12 recite whereby or wherein clauses that are intended results of the step(s) of claim 1 and are thus not given patentable weight, The court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “’whereby’ clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. Even if claims 10–12 were given weight, the recited enhancements would necessarily occur from the taught method. Further, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of a taught method has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As described supra, O’Hagan teaches a vaccination schedule comprising intramuscular priming and multiple intranasal boosts that led to increases in serum IgG levels (p. 18, para. [0163], lines 1–3; Table 4; and Figure 2). Therefore, the substantially identical vaccine used in the method of O’Hagan teaches the intended results of claim 10 by way of its inseparable chemical properties. Thus, claims 1–2, 6, and 8–10 are obvious and are here rejected. Claims 1–2 and 6–12 are rejected under 35 U.S.C. 103 as being unpatentable over O’Hagan (US 2003/0072764 A1, published 04/17/2003) in view of Schouten (US 2012/0219586 A1, published 08/30/2012) as applied to claims 1–2, 6, and 8–12 above, and further in view of Hsu et al. (US 2008/0102078 A1, published 05/01/2008, hereinafter “Hsu”). The combination of O’Hagan and Schouten renders obvious claims 1–2, 6, and 8–10 for all reasons in the 103 supra incorporated herein its entirety. Neither O’Hagan nor Schouten teach the LTh(αK) E. coli heat-labile toxin variant as an adjuvant. This deficiency is remedied by Hsu, who teaches an E. coli heat-labile toxin variant comprising an S61K mutation on subunit A of its holoenzyme (p. 1, para. [0005], lines 4–7), hereinafter “LTh(αK)” as so named in the instant specification (p. 8, para. [0034]). They demonstrated that LTh(αK) exhibited reduced toxicity compared to the wild-type LT through two separate experiments (p. 5, para [0026], lines 18–20 and Table 2; p. 5, para. [0027], lines 15–17). They also demonstrated reduced toxicity relative to alternative detoxified variants (p. 5, para [0026, lines 20–22 and Table 2; p. 5, para. [0027], lines 17–19). They further demonstrated increased hemagglutination inhibition titers when LTh(αK) was used as an adjuvant in an intranasal inactivated influenza vaccine in a BALB/c mouse model compared to vaccination with the inactivated virus alone (p. 6, para [0029], lines 10–12). Given the known efficacy of detoxified E. coli heat-labile toxin as an effective adjuvant in mucosal vaccines, as described by O’Hagan, it would have been obvious to a person having ordinary skill in the art at the time of filing to use the known variant LTh(αK) of Hsu in O’Hagan’s mucosal booster vaccine formulation. This is due to its reduced toxicity relative to both the wild-type LT, which cause side effects which limits its clinical use, as well as to other detoxified variants. In doing so, they would create an adjuvanted mucosal booster vaccine that induced an enhanced immune response relative to an unadjuvanted virus while reducing the side effects that typically preclude the clinical usage of LT as an adjuvant. Thus, claim 7 is obvious, and is here rejected. Taken all together, the combined teachings supra render all claims obvious. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 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. Claims 1–2 and 6–12 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1–5 and 7 of U.S. Patent No. 8,110,197 B2 (published 02/07/2012) in view of O’Hagan (US 2003/0072764 A1, published 04/17/2003) and Schouten (US 2012/0219586 A1, published 08/30/2012), and Hsu (US 2008/0102078 A1, published 05/01/2008). The combined teachings of O’Hagan, Schouten, and Hsu render all the instant claims above obvious as discussed supra (Claim Rejections - 35 USC § 103), each being incorporated here in their entireties. The addition of the patented claims only further supports this finding of obviousness. Claims 1–2 of the reference patent recite a detoxified E. coli LT containing a single S61K point mutation of its subunit A, hereinafter “LTh(αK)” as so named in the instant specification (p. 8, para. [0034]). Claims 3–4 of the reference patent recite an immune composition comprising an antigen and LTh(αK) as an adjuvant. Claim 5 of the reference patent recites an antigen from a bacterium or a virus, and claim 7 of the reference patent recites antigen selected from a group of viruses including influenza virus. Thus, the patented claims are drawn to genera that encompass the products used in the instant claims. However, the combined prior art above renders obvious the instant methods and so the combination of the patented claims over related subject matter only further supports this obviousness. Thus, the combination of the reference claims with the prior art above renders obvious claims 1–2 and 6–12, and they are rejected here. Claims 1–2 and 7–12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11,986,520 B2 (published 05/21/2024, in IDS submitted 06/28/2024) in view of O’Hagan (US 2003/0072764 A1, published 04/17/2003). The combined teachings of O’Hagan, Schouten, and Hsu render all the instant claims above obvious as discussed supra (Claim Rejections - 35 USC § 103), each being incorporated here in their entireties. The addition of the patented claims only further supports this finding of obviousness. Claim 4 of the reference patent recites a method for the treatment of prophylaxis of a coronavirus infection in a subject in need thereof comprising administering a therapeutically effective amount of LTh(αK) as an immunomodulator and coronavirus or coronavirus antigen. The addition of the patented claims over related subject matter only further supports this obviousness. Thus, the combination of the reference claims with the prior art above renders obvious claims 1–2 and 6–12, and they are rejected here. Claim Rejections - Improper Markush Groupings Claims 2, 6, and 8 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117. The Markush grouping of coronavirus and influenza virus in claim 2 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: The two viruses have distinct structural features that lead to distinct pathologies and host immune responses. Their structural proteins display distinct epitopes that are recognized by antibodies, requiring the host immune response to develop distinct antibodies each with their own unique set of Complementarity Determining Regions. To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael J.A. Bellecourt whose telephone number is 571-270-5356. The examiner can normally be reached Monday through Thursday, 8:00 a.m. to 3:00 p.m. ET. 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. /MICHAEL J.A. BELLECOURT/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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Prosecution Timeline

Sep 28, 2023
Application Filed
Oct 06, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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