DETAILED ACTION
Disposition of Claims
Claims 1-2, 4-5, 8-15, 17-19, 22-23, and 27-28 were pending. Claims 2-3, 6-8, 16, 20-21, 23-26, and 28 have been cancelled. Amendments to claims 1, 5, 11, 13, 15, 17-19, 22, and 27 are acknowledged and entered. New claims 29-34 are acknowledged and entered. Claims 1, 4-5, 9-15, 17-19, 22, 27, and 29-34 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 US20240173399A1, Published 05/30/2024. Amendments to the specification presented on 06/04/2026 are acknowledged and entered.
Response to Arguments
Applicant's arguments filed 06/04/2026 regarding the previous Office action dated 02/23/2026 have been fully considered. If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn. If the arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Applicant-Initiated Interview
On 05/21/2026, the Examiner held an interview with Applicant’s representative, Jodi Connolly.
Optional Authorization to Initiate Electronic Communications
The Applicant’s representative may wish to consider supplying a written authorization in response to this Office action to correspond with the Examiner via electronic mail (e-mail). This authorization is optional on the part of the Applicant’s representative, but it should be noted that the Examiner may not initiate nor respond to communications via electronic mail unless and until Applicant’s representative authorizes such communications in writing within the official record of the patent application. A sample authorization is available at MPEP § 502.03, part II. If Applicant’s representative chooses to provide this authorization, please ensure to include a valid e-mail address along with said authorization.
Drawings
(Objection withdrawn.) The objection to the drawings is withdrawn in light of the amendments to the specification.
Claim Objections
(Objection withdrawn.) The objection to Claim 1 is withdrawn in light of the amendments to the claim.
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 1 is drawn to an immunogenic composition, comprising:
i) a severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) protein comprising a SARS-CoV-2 Spike 1 (S1) protein comprising at least 95% sequence identity to SEQ ID NO: 2; and
an adjuvant comprising CpG oligodeoxynucleotide, Poly I:C, and IL-15,
wherein the S1 protein and the adjuvant are incorporated in poly(d,l-lactide-co-glycolide)(PLGA) or 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOTAP) nanoparticles.
Further limitations on the immunogenic composition of claim 1 are wherein the immunogenic composition is further comprising a pharmaceutically acceptable carrier (claim 4); wherein the SARS-CoV-2 S1 protein comprises at least 98% sequence identity to SEQ ID NO: 2, 3, 4, 5, 6, 12 or 15 (claim 29); wherein the SARS-CoV-2 S1 protein comprises SEQ ID NO: 2, 3, 4, 5, 6, 12 or 15 (claim 30); and wherein the SARS-CoV-2 S1 protein comprises SEQ ID NO: 2 (claim 31).
Claim 5 is drawn to a nanoparticle, comprising:
a SARS-CoV-2 Spike (S) protein comprising a SARS-COV-2 S1 protein comprising at least 95% sequence identity to SEQ ID NO: 2;
an adjuvant comprising CpG oligodeoxynucleotide, Poly I:C, and/or IL-15,
wherein the S1 protein and the adjuvant are incorporated in poly(d,l-lactide-co-glycolide)(PLGA) or 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOTAP) nanoparticles.
Further limitations on the nanoparticle of claim 5 are wherein the SARS-CoV-2 S1 protein comprises at least 98% sequence identity to SEQ ID NO: 2, 3, 4, 5, 6, 12, or 15 (claim 32); wherein the SARS-CoV-2 S1 protein comprises SEQ ID NO: 2, 3, 4, 5, 6, 12 or 15 (claim 33); and wherein the SARS-CoV-2 S1 protein comprises SEQ ID NO: 2 (claim 34).
Claim 9 is drawn to an immunogenic composition comprising the nanoparticle of claim 5 and a pharmaceutically acceptable carrier.
Claim 10 is drawn to a glass vial, plastic vial, or syringe, comprising the immunogenic composition of claim 1.
Claim 11 is drawn to a method of eliciting an immune response against SARS-CoV-2 in a subject, comprising:
administering to the subject an effective amount of a priming dose of an immunogenic composition comprising a SARS-CoV-2 S protein, or S1 protein and an adjuvant; and subsequently intranasally administering to the subject an effective amount of one or more booster doses of the immunogenic composition of claim 9; thereby eliciting the immune response.
Further limitations on the method of claim 11 are wherein a first booster dose is administered at least 2 weeks, at least 3 weeks, at least 4 weeks, at least 5 weeks, at least 6 weeks, at least 7 weeks, at least 8 weeks, at least 10 weeks, at least 12 weeks, at least 16 weeks, at least 6 months, at least 9 months, at least 12 months, at least 18 months, at least 24 months, or at least 36 months after administering the priming dose (claim 13); wherein the one or more booster doses comprises 2, 3, 4, 5, 6, 7, 8, 9 or 10 booster doses (claim 14); wherein the immune response inhibits SARS-CoV-2 infection in the subject; inhibits or prevents severe COVID19 disease in the subject; reduces the risk of transmission of SARS-CoV-2 to other subjects; increases production of dimeric IgA specific for SARS-CoV-2 S1 and IFNa; provides 100% protection against subgenomic viral RNA from SARS-CoV-2 viral challenges in the upper and lower respiratory tracts of the subject; induces a neutralizing antibody titer of at least 100, at least 200, at least 300, at least 350; or combinations thereof (claim 15); wherein administering the priming dose comprises intramuscular administration (claim 17); wherein generating the immune response inhibits replication of the SARS-CoV-2 in the subject (claim 18); and wherein the method is further comprising administering to the subject a COVID-19 treatment, wherein the COVID-19 treatment comprises remdesivir, galidesivir, lenzilumab, molnupiravir, hydroxychloroquine, dexamethasone, arbidol, favipiravir, baricitinib, lopinavir/ritonavir, zinc ions, and/or interferon beta-lb (claim 27).
Claim 12 is drawn to a method of eliciting an immune response against SARS-CoV-2 in a subject, comprising: administering to the subject an effective amount of a priming dose of a SARS-CoV-2 vaccine; and subsequently intranasally administering to the subject an effective amount of one or more booster doses of the immunogenic composition of claim 9; thereby eliciting the immune response.
Further limitations on the method of claim 12 are wherein the SARS-CoV-2 vaccine is: an mRNA vaccine, a chimpanzee adenovirus-vectored vaccine, a protein vaccine, an adenovirus serotype 26 vectored vaccine, or a DNA vaccine (claim 19).
Claim 22 is drawn to a method of eliciting an immune response against SARS-CoV-2 in a subject, comprising: administering to the subject an effective amount of a priming dose of an immunogenic composition comprising the SARS-CoV-2 S1 protein of SEQ ID NO: 2, and alum; and subsequently intranasally administering to the subject an effective amount of one or more booster doses of nanoparticles comprising the SARS-CoV-2 S1 protein of SEQ ID NO: 2, CpG oligodeoxynucleotide, Poly I:C, and IL-15, wherein the nanoparticles in a first booster dose comprise PLGA or DOTAP.
Claim Rejections - 35 USC § 112(b); Second Paragraph
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claims 1 and 5 and dependent claims 2, 4, 8-15, 17-19, and 27-28 thereof under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The rejection of Claim 11 and dependent claims 13-15 and 27 thereof under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The rejection of Claim 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claim.
(Rejection withdrawn.) The rejection of Claim 15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claim.
(Rejection withdrawn.) The rejection of Claims 17 and 18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The rejection of Claim 17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claim.
(Rejection withdrawn.) The rejection of Claim 19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claim.
(Rejection withdrawn.) The rejection of Claim 27 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claim.
(New rejection – necessitated by amendment.) Claims 1, 5 and 22 and dependent claims 4, 9-15, 17-19, 27, and 29-34 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “1,2-dioleoyl-sn-glycero-3-phosphoethanolamine” in claims 1, 5, and 22 is abbreviated in the claim to mean “DOTAP,” while the accepted abbreviation is “DOPE.” The term is indefinite because the specification does not clearly redefine the term. “DOTAP” is commonly accepted as the abbreviation for “1,2-dioleoyl-3-trimethylammonium-propane”.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant claims 1, 5, and 22 are rejected on the grounds of being indefinite. Claim(s) 4, 9-15, 17-19, 27, and 29-34 are also rejected since they depend from claim 1, 5, or 22, but do not remedy these deficiencies of claims 1, 5, or 22.
Claim Rejections - 35 USC § 112(a); First Paragraph
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claim 15 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in light of the amendments to the claim.
(Rejection withdrawn.) The rejection of Claims 1-2, 4-5, 8-15, 17-19, 22-23, and 27-28 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The rejection of Claims 1-2, 4-5, 8-15, 17-19, 22-23, and 27-28 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in light of the amendments to the claims.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claims 1, 4-5, 9-15, 18-19, and 28 under 35 U.S.C. 102(a)(2) as being anticipated by Meinke et. al. (US20230038284A1; Priority 03/01/2020; hereafter “Meinke”) is withdrawn in light of the amendments to the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-5, 9-15, 17-19, 22, 27, and 29-34 are rejected under 35 U.S.C. 103 as being unpatentable over Meinke et. al. (US20230038284A1; Priority 03/01/2020; CITED ART OF RECORD; hereafter “Meinke”) in view of Zhu et. al. (WO2011026111A1, Pub. 03/03/2011; hereafter “Zhu”);
Gupta et. al. (Gupta T, et. al. Int Immunopharmacol. 2020 Sep;86:106717. Epub 2020 Jun 18.; hereafter “Gupta”); and
Li et. al. (Li YD, et. al. J Biomed Sci. 2020 Dec 20;27(1):104.; hereafter “Li”.)
The Prior Art
Meinke teaches CpG-adjuvanted SARS-CoV-2 vaccines and compositions and methods of producing and administering said vaccines to subjects in need thereof (entire document; see abstract.) Meinke teaches the vaccine comprises inactivated SARS CoV-2 particles which comprise S proteins having at least 95% amino acid identity to SEQ ID NO: 3, and comprises a CpG-containing oligodeoxynucleotide (CpG-ODN) (reference claims 1, 19). Meinke teaches the adjuvant may be alone or with other adjuvants, such as alum (¶[0016][0042-0044]). Instant SEQ ID NO: 1 is 100% identical to reference SEQ ID NO: 3 (SARS CoV-2 S protein, GenBank: QHD43416); see alignment in 35 USC 102 rejection from previous Office action.) Meinke teaches the composition may comprise pharmaceutically acceptable excipients (¶[0131-0132]; instant claims 4, 9). Meinke teaches vials, syringes, and containers which comprise the composition (¶[0011][0141][0170]; instant claim 10). Meinke teaches the different strains and variants which can generate the particle of the instant claims (e.g. B.1.1.7 is an alpha strain; ¶[0146]).
Meinke teaches that the composition may be administered to a subject in need thereof in a prime dose followed by a second dose at least 28, 60, 70, 80, 90, or 120 days after the first dose (¶[0136]; instant claims 11-12), or the composition can be used only as a booster dose following a different priming dose of a SARS CoV-2 vaccine, wherein the different vaccine may be a subunit vaccine, a recombinant viral vector vaccine, or an mRNA vaccine (¶0137]; instant claims 13-14, 19.) Meinke teaches the composition would inhibit SARS CoV-2 infection and prevent related COVID-19 disease (¶[00122][0125]), wherein the immune response generates antigen-specific antibodies (¶[0126]), and the amount of subgenomic viral RNA is decreased (¶[0020][0030-0031]; Figs. 9, 19-20; instant claims 15, 18.) Meinke teaches the dosage can be administered subcutaneously or intramuscularly (¶[0135]). As instant SEQ ID NO: 2 is aa 16-685 of instant SEQ ID NO: 1 that is missing the signal peptide and only comprises the S1 protein, and as Meinke teaches the use of S1 minus the signal peptide in compositions, especially for vaccination (Figs. 4-5, ¶[0128][0137][0191-0192][0272]), Meinke teaches a composition which comprises SEQ ID NO: 2 and adjuvant (instant claims 29-34).
Zhu teaches compositions comprising pathogenic antigens, such as viral antigens, and immunostimulatory agents, wherein the composition is appropriate for mucosal delivery (entire document; see abstract; reference claim 1.) Zhu teaches that the immunostimulatory agents may include toll-like receptor (TLR) ligands (abstract; reference claim 11) and the composition would include a microparticle carrier encapsulating multiple nanoparticles within the microparticle carrier, wherein the nanoparticle comprises poly(lactic-co-glycolic acid) (PLGA)(reference claims 1, 9-10). The one or more TLR ligands in the composition may include poly I:C and CpG or combinations thereof (reference claims 12, 14) and may further include the cytokine IL-15 (reference claim 15). Zhu teaches it was determined that a triple combination of TLR ligands boosts dendritic cells to produce IL- 15, and thus augments immunity by enhancing the T cell quality (especially avidity)(p. 44, ¶2). Zhu teaches the antigens may be viral surface antigens (p. 11, ¶3; p. 54, ¶3), such as coronavirus (CoV) antigens from SARS CoV (p. 47, ¶3). Zhu teaches that for HIV administration, delivery to the rectal mucosa is preferable as opposed to distant infection sites, such as intranasal administration (p. 49, ¶2). However, with distinct viruses, mucosal delivery at locations which would be more relevant to the pathogenicity of said virus would be obvious, such as intranasal delivery for respiratory viruses, such as SARS CoV viruses.
Gupta teaches intranasal administration of a TLR3 agonist, poly(I:C), with an inactivated SARS-CoV vaccine induced IFN-β and IFN-γ production and protected the animals from SARS-CoV infection. Gupta suggests poly(I:C) as a prophylactic measure should be further evaluated for use in aged or high-risk individuals, and teaches that there are many ways an intranasal application of vaccines may benefit in SARS-CoV-2 vaccination, in that the mucosal immune response generated following intranasal vaccine application may block the viral entry and alleviate the concern associated with systemic administration of inactivated vaccine (i.e. immunopathology in the lungs.) Gupta teaches that CpG ODN 2006 was administered intranasally with an inactivated SARS CoV vaccine and showed induction of significant levels of SARS-CoV specific IgG antibodies in sera, and a detectable amount of IgA antibodies in sera and mucosal secretion. Another TLR3 ligand, PIKA (Polyinosinic-Polycytidylic Acid Based Adjuvant) which a stabilized derivative of poly(I:C), also produced similar results when administered with inactivated SARS-CoV vaccine. Both the intranasal and intraperitoneal administration of PIKA with inactivated SARS-CoV induced significant levels of both mucosal and serum antibodies. Gupta teaches poly(I:C) was superior to alum with a Chimeric VLPs expressing MERS-CoV RBD protein vaccine when administered to mice, and poly(I:C) elicited stronger neutralizing antibody as well as cell-mediated responses that prevented pseudotyped virus entry into susceptible cells. Gupta teaches the CpG ODN, poly(I:C), and R848(TLR7/8) ligands when used with HLA-A*0201 restricted SARS-CoV S epitopes, all three agonists enhanced the epitope-specific CD8+ T cells (p. 6, ¶ bridging pages to rt. Col., ¶2). Gupta further teaches heterologous prime/boost vaccination strategies were tested for MERS CoV, and showed that delivery of spike protein nanoparticles as a prime followed by an adenovirus-based spike protein delivery induced both Th1 and Th2 immune responses and protected the mice upon viral challenge (Table 3).
Li teaches SARS-CoV-2 is a new type of coronavirus that causes the Corona virus Disease 2019 (COVID-19), and summarizes key takeaways from previous vaccination studies of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) and Middle East Respiratory Syndrome Coronavirus (MERS-CoV), highlighting the pros and cons of each immunization strategy (entire document; see abstract.) Li teaches the delivery of spike protein antigen with CpG adjuvants and intranasal delivery of CoV antigens (Table 2), and noted that the delivery route of vaccines may need to be optimized for SARS-CoV-2 as there was a noted difference in antibody responses depending on delivery route of the antigen (p. 9, left col., ¶1). Li teaches that remdesivir and dexamethasone were the two leading drugs that showed promising clinical evidence in shortening the time to recovery and decreasing mortality rates, and that these treatment options can be complementary to SARS-CoV-2 vaccines to mitigate the pandemic (p. 18, left col., ¶1; instant claim 27).
Given the teachings of Meinke, a skilled artisan would be apprised as to SARS-CoV-2 S1 antigens and immunogenic compositions thereof, especially ones which further comprised TLR agonist adjuvants, such as CpG, in a prime/boost vaccination regimen. Given the teachings of Zhu, a skilled artisan would be apprised as to compositions for delivering viral surface antigens via mucosal delivery, and the inclusion of further TLR agonists beyond CpG, such as poly I:C, and the inclusion of cytokines, such as IL-15. Given the teachings of Zhu, a skilled artisan would be apprised as to the use of PLGA-based nanoparticles for stabilization of the vaccine cargo, especially for mucosal delivery. Given the teachings of Gupta, a skilled artisan would be motivated to use protein-based antigens for mucosal delivery in treatment of SARS-CoV-2 along with TLR agonist adjuvants, such as poly I:C and CpG, given the results seen in other coronavirus studies with SARS CoV and Middle East respiratory syndrome coronavirus (MERS CoV). Given the suggestion by Gupta for SARS-CoV-2 vaccination strategies, Gupta noted that heterologous vaccination strategies broadened the type of immune response elicited and provided protection against viral challenge. Given the teachings of Li, one of skill would be further motivated to try past CoV-vaccination strategies taught by Gupta, and also to further combine said strategies with other drugs or compositions that showed promise in treatment of this emerging pandemic. Therefore, arriving at the limitations of instant claims 1, 5, 17, 22, and 27 would be obvious to a skilled artisan, given the related teachings of Meinke, Zhu, Gupta, and Li.
It would have been obvious to one of ordinary skill in the art to modify the methods and compositions taught by Meinke in order to encapsulate the antigens within PLGA-based nanoparticles, thereby stabilizing the antigens for delivery via the mucosal route. One would have been motivated to do so, given the suggestion by Zhu that delivery of viral surface antigens via the mucosal route while encapsulated in PLGA nanoparticles stabilized the composition, and that co-delivery of TLR agonist adjuvants such as CpG, poly I:C generated a therapeutically effective immune response against the viral surface antigen. There would have been a reasonable expectation of success, given the knowledge that the induction of IL-15 stimulated the immune response and that inclusion of IL-15 in the composition would potentially enhance the adjuvanting effects of the other adjuvants, as taught by Zhu. There would have been further motivation to deliver the SARS-CoV-2 antigen intranasally, given the results from previous related viruses when delivered intranasally with TLR agonists, as shown by Gupta. There would have been further motivation to investigate the proper delivery route, such as intranasal delivery, and the potential combination of components with the vaccination regimen, given the teachings of Li. Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 06/04/2026, with respect to the rejection(s) of claims under 35 USC 102 over Meinke have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, new grounds of rejection are made utilizing the teachings of Meinke in view of Zhu, Gupta, and Li.
While it was persuasive that Meinke failed to teach PLGA or DOTAP nanoparticles, such a limitation was known in the art, as taught by Zhu. The further limitations, such as intranasal administration, would be obvious given the teachings and motivation provided by Zhu, Gupta, and Li. Therefore, while it is persuasive that Meinke fails to anticipate the claims, Meinke renders obvious the claims in view of the prior art teachings, namely Zhu, Gupta, and Li.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and is listed below.
Stevceva L. Curr Med Chem. 2011;18(33):5079-82. Teaches combination of CpG and poly I:C, and relates to IL-15 immunological-based maturation. Not utilized as rejection would be redundant to those set forth supra.
Sui Y, et. al. Vaccine. 2011 Dec 9;30(1):59-68. Epub 2011 Oct 29. Provides motivation to combine TLR agonists with IL-15 as adjuvant in viral vaccine formulations. Not utilized as rejection would be redundant to those set forth supra.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL B GILL whose telephone number is (571)272-3129. The examiner can normally be reached on M to F 8:00 AM to 5:00 PM Eastern.
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 on 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.
/RACHEL B GILL/
Primary Examiner, Art Unit 1671
Prosecution Insights