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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1,2,10, 12-14, 17, 18, 22-24, 26, 30, 37, 39, and 43, in the reply filed on 1/30/2026 is acknowledged. Applicant’s editing of claim numbers, post-election, is also acknowledged. Applicant’s election, without traverse, of the following: a TLR9 agonist as the species of PRR agonist; SARS-CoV-2 as the species of beta coronavirus; and SARS-CoV-2 spike protein as the species of beta coronavirus spike protein is further acknowledged. Post renumbering, claims 9, 46-47 and 64 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention there being no allowable generic or linking claim.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 1, 2, 10, 12-14, 17-18, 22-24, 26, 29, 36, 38, and 42 are under consideration.
Priority
Provisional application #63/032,422 is acknowledged and the effective filing date of 05/29/2020 used for examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/26/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See page 54 and 57 of the specification.
Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o).
The specification recites: In some embodiments, the adjuvantation system prolongs the effect of a vaccine. It does not recite nor provide details on how it “prolongs a protective effect” (as recited in claim 42).
Appropriate correction is required.
Claim Interpretation
SARS-CoV-1 and SARS-CoV (as used by Graham et al. & Zhao et al.) are equivalent.
Claim Objections
Claim 1, 12-14, 17-18, 26, 36, 42 are objected to because of the following informalities:
Claim 1: Change “pattern recognition receptors” to “pattern recognition receptor”.
Claims 1, 12, 13, 14, 17, 18, 36, 42: Change “Beta coronavirus” to “betacoronavirus”.
Claim 26: Change “immune-compromised” to “immunocompromised”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 42 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.
Claim 42 recites “wherein the adjuvantation system prolongs a protective effect in the subject against the Beta coronavirus antigen, compared to when the Beta coronavirus antigen is administered alone”. It is unclear what the metes and bounds of “prolong” and “effect” are in the phrase “prolongs a protective effect”.
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, 10, 13, 14, 17, 22-24, 29, 36, 38, and 42 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Graham et al. (Graham)(US20200061185A1)(See PTO-892 Notice of References Cited) as evidenced by Rudicell et al. (Rudicell) (See PTO-892 Notice of References Cited).
Claims 1, 2, 10, 13, 14, 17, 22-24, 29, 36, 38, and 42 as submitted 01/30/2026.
Regarding claims 1, 2, 10, 13, 17: Graham teaches reference claim 47 - a method for generating an immune response to a coronavirus S ectodomain (as recited in claim 13) in a subject, comprising administering to the subject an effective amount of the immunogen (as defined in reference claim 1) to generate the immune response…and reference claim 48 - the method of claim 47, wherein the immune response treats or inhibits infection with the coronavirus. In reference claim 5, Graham limits the immunogen to being from a betacoronavirus (as recited in claim 17). Examples of betacoronavirus provided are MERS-CoV and SARS-CoV, with MERS-CoV specifically cited in several of the claims. Graham also teaches “Adjuvants can be used in combination with the disclosed immunogens” and lists a variety of adjuvants to include alum and TLR agonists, including TLR9 agonists, as well as the Sigma Adjuvant System [0029, 0034](as recited in claims 2, 10).
Note: According to Rudicell, the Sigma Adjuvant System consists of a stable oil-in-water emulsion containing MPLA [a TLR3 agonist] and synthetic trehalose dicorynomycolate (p. 6212, Table 1). Both TLR3 and TLR9 are examples of pattern recognition receptor agonists (see instant application claim 2).
Regarding claim 14, Graham teaches Coronavirus S ectodomain trimers stabilized in a prefusion conformation, nucleic acid molecules and vectors encoding these proteins (Abstract).
Regarding claim 22-24, Graham teaches “The immunogens described herein, and immunogenic compositions thereof, are provided to a subject in an amount effective to induce or enhance an immune response against the coronavirus S protein in the immunogen in the subject, preferably a human” [0282]. Graham also teaches “The amount utilized in an immunogenic composition is selected based on the subject population (e.g., infant or elderly)”[0288].
Regarding claim 29, Graham teaches “The administration of a disclosed immunogen can be for prophylactic or therapeutic purpose” [0281].
Accordingly, Graham teaches each and every aspect of claims 1, 2, 10, 13, 14, 17, 22-24, and 29.
Regarding claims 36, 38, and 42, the expressed intended results flow from the composition and method steps positively recited in the claims they are dependent on, e.g., claims 1 and 36 (See MPEP 2111.04, I).
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.
Claims 1, 2, 10, 13, 14, 17, 22-24, 26, 29, 36, 38, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Graham et al. (Graham)(US20200061185A1)(See PTO-892 Notice of References Cited) as evidenced by Rudicell et al. (Rudicell) (See PTO-892 Notice of References Cited) and in view of Zumla et al. (Zumla)(See PTO-892 Notice of References Cited).
Claims 1, 2, 10, 13, 14, 17, 22-24, 26, 29, 36, 38, and 42 as submitted 01/30/2026
Regarding claims 1, 2, 10, 13, 17: Graham teaches reference claim 47 - a method for generating an immune response to a coronavirus S ectodomain (as recited in claim 13) in a subject, comprising administering to the subject an effective amount of the immunogen (as defined in reference claim 1) to generate the immune response…and reference claim 48 - the method of claim 47, wherein the immune response treats or inhibits infection with the coronavirus. In reference claim 5, Graham limits the immunogen to being from a betacoronavirus (as recited in claim 17). Examples of betacoronavirus provided are MERS-CoV and SARS-CoV, with MERS-CoV specifically cited in several of the claims. Graham also teaches “Adjuvants can be used in combination with the disclosed immunogens” and lists a variety of adjuvants to include alum and TLR agonists, including TLR9 agonists, as well as the Sigma Adjuvant System [0029, 0034](as recited in claims 2, 10).
Note: According to Rudicell, the Sigma Adjuvant System consists of a stable oil-in-water emulsion containing MPLA [a TLR3 agonist] and synthetic trehalose dicorynomycolate (p. 6212, Table 1). Both TLR3 and TLR9 are examples of pattern recognition receptor agonists (see instant application claim 2).
Regarding claim 14, Graham teaches Coronavirus S ectodomain trimers stabilized in a prefusion conformation, nucleic acid molecules and vectors encoding these proteins (Abstract).
Regarding claim 22-24, Graham teaches “The immunogens described herein, and immunogenic compositions thereof, are provided to a subject in an amount effective to induce or enhance an immune response against the coronavirus S protein in the immunogen in the subject, preferably a human” [0282]. Graham also teaches “The amount utilized in an immunogenic composition is selected based on the subject population (e.g., infant or elderly)”[0288].
Regarding claim 29, Graham teaches “The administration of a disclosed immunogen can be for prophylactic or therapeutic purpose” [0281].
Regarding claims 36, 38, and 42, the expressed intended results flow from the composition and method steps positively recited in the claims they are dependent on, e.g., claims 1 and 36 (See MPEP 2111.04, I).
Although Graham teaches elderly human subjects [0288], Graham does not teach additional details about subjects in need thereof such as their comorbidities.
Regarding claim 26, Zumla, however, teaches the Middle East respiratory syndrome (MERS) and high mortality rates in family-based and hospital-based outbreaks, especially in patients with comorbidities such as diabetes and renal failure (p. 995, Introduction). Zumla also teaches risk factors for development of severe disease, in addition to an immunocompromised state, include comorbidity (e.g., obesity, diabetes, cardiac disease, and lung disease)(p. 1001).
One of ordinary skill in the art would have been motivated to use a method of inducing a protective immune response against MERS-CoV in a human subject, with comorbidities as taught by Zumla because these subjects are more at risk of infection, serious morbidity and mortality from MERS-CoV and, from a community health perspective, at risk of transmitting the infection (See MPEP Rationale G. Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention).
One of ordinary skill in the art would have had a reasonable expectation of success for inclusion of elderly human subjects or subjects with specific comorbidities to be considered for MERS-CoV immunization efforts as at risk or high risk human subjects, within the vaccinology field, are typically prioritized to receive vaccinations and ultimately benefit from them.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Graham as evidenced by Rudicell as applied to claims 1, 13 and 17 above (see § 102 rejection) and over Graham as evidenced by Rudicell in view of Zumla, as applied to claims 1, 13 and 17 above (see § 103 rejection) and further in view of Liu et al. (Liu)(See PTO-892 Notice of References Cited).
Claims 12 and 18 as submitted 01/30/2026.
Graham, Rudicell and Zumla teach claims 1, 13 and 17 but do not teach SARS-CoV-2 or the SARS-CoV-2 spike protein.
Liu, however, teaches an adjuvanted nanovaccine against SARS-CoV-2 with recombinant S1 subunit [S1 subunit is one component of SARS-CoV-2 transmembrane spike (S) glycoprotein (p. 2)] from SARS-CoV-2 (as recited in claims 12 and 18) where the adjuvants include both CpG ODN for a TLR9 agonist and monophosphoryl lipid A (MPLA) for a TLR4 agonist (p. 2).
One of ordinary skill in the art would have been motivated to substitute the SARS-CoV-2 S1 subunit as the betacoronavirus antigen and SARS-CoV-2 as the betacoronavirus both as taught by Liu into the formulation as taught by Graham, particularly since there appeared to be compatibility as well as increased immunogenicity with the antigen and the TLR agonists used in an adjuvant system approach (See MPEP Rationale B, Simple substitution of one known element for another to obtain predictable results).
One of ordinary skill in the would have had reasonable expectation of success for using the S1 subunit and TLR agonists (one or both) as taught by Liu. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated in the context of coronavirus vaccinology and/or immunity, and commonly used as evidenced by the applied prior art.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
With respect to Double Patenting, it is noted that claim 1 of U.S. Patent No. 11633473 recites a method of inducing an immune response to an antigen in a subject in need thereof, the method comprising administering to the subject an effective amount of an antigen and an effective amount of an adjuvantation system comprising a Stimulator of Interferon Genes (STING) ligand, wherein the subject is a newborn (wherein STING ligand is a withdrawn species recited in instant claim 2).
No claims allowed.
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/C.C./Examiner, Art Unit 1672
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672