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 .
Claim Status
Claims 1-40 were previously pending.
A non-final Office Action was mailed 29 September 2025.
In response to that Office Action, Applicant filed an Amendment/Request for Reconsideration on 28 January 2026.
As a result of that Amendment, claims 2, 10, and 18 were cancelled, claims 1, 3-9, 11-17, 19-26, and 29-32 were amended, and no claims were added. Therefore, claims 1, 3-9, 11-17, and 19-40 are now pending and under examination.
Information Disclosure Statement (IDS)
The IDS (1) filed on 28 January 2026 has been considered by the examiner. A signed
copy is enclosed.
Withdrawn Claim Rejections
Applicant has amended independent claim 1 from a composition to a method comprising administering a composition which has been amended to include both a naked STING agonist and a STING agonist encapsulated in a lipid-based particle. In addition, Applicant has cancelled claims 2, 10, and 18. Therefore, all previous claim rejections are moot and hereby withdrawn.
New Claim Rejections
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Because Applicant has amended the scope of the claims, the following new claim rejections are necessitated by amendment.
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.
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, 3-6, 9, 11, 14-16, 19-25, 29, 31, and 33-40 are rejected under 35 U.S.C. 103 as being unpatentable over Quay (cited in previous Office Action as: PGPub No. US 2023/0364221 A1; published: 16 November 2023; effective filing date: 15 October 2020) in further view of Gutjahr (“The STING ligand cGAMP potentiates the efficacy of vaccine-induced CD8+ T cells,” published: 04 April 2019).
Quay discloses viral vaccine compositions for inoculating a subject against a coronavirus, an influenza virus, or both to elicit a sustained immune response in a subject (abstract).
Regarding claim 1, Quay discloses a bivalent viral vaccine composition containing a negatively charged lipid nanoparticle and cyclic guanosine monophosphate-adenosine monophosphate (2ˈ3ˈ-cGAMP) as an adjuvant to enhance the immune response in the subject upon administration of the viral vaccine (Example 1, [0101]). Quay discloses the 2ˈ3ˈ-cGAMP adjuvant is encapsulated in a negatively charged lipid nanoparticle (Example 1, [0101]). Finally, Quay discloses administering the vaccine composition to a human subject (Example 1, [0103]).
Regarding claims 3, 4, and 5, Quay discloses the composition comprises both the receptor-binding S1 fragment and the fusion S2 fragment in a prefusion conformation (“The bivalent viral vaccine contains a SARS-CoV-2 spike protein prefusion complex and a SARS-CoV-2 spike protein post-fusion complex” - Example 1, [0100]).
Regarding claim 6, Quay discloses the viral vaccine may contain antigens from one or more of SARS-CoV-2, SARS-CoV, or MERS-CoV ([0037]). The viral vaccine may contain one or more of SARS-CoV-2 S protein or fragment thereof ([0037]). The viral vaccine may also contain a coronavirus nucleocapsid protein ([0051]).
Regarding claim 9, Quay discloses the composition is in the form of a nasal spray (Example 1, [0102]).
Regarding claim 11, Quay discloses the lipid-based particle comprises DPPC, DPPG, cholesterol, and DPPE-PEG2000 in a ratio of 10:1:1:1 (Example 1, [0101]).
Regarding claim 14, Quay discloses the composition may be formulated for nasal delivery and administered via nasal spray ([0075]). The spray can be in liquid form ([0076]).
Regarding claims 15 and 16, Quay discloses the composition comprises 2ˈ3ˈ-cGAMP (Example 1, [0101]).
Regarding claims 19 and 22, Quay discloses administering the embodiment compositions via the nasal passage, which may result in improved immunity at the site of infection and reduce the risk of infection or the severity of respiratory symptoms in the event of infection ([0020], [0070]).
Regarding claim 20, Quay discloses nasal delivery of the formulations for treatment or prevention of a respiratory viral infection ([0088]). Treatment implies the subject is currently infected with the virus and implies a sample was taken and confirmed positive (detectable level) for the viral infection. Therefore, the limitations of claim 20 flow naturally from the disclosures of Quay.
Regarding claim 21, Quay discloses the viral vaccine embodiments administered to a subject to inoculate the subject against a virus, thereby preventing a viral infection ([0091]). Quay further discloses preventing a viral infection may comprise reducing the chance the subject becomes infected with the virus ([0091]). Therefore, although Quay does not explicitly teach a sample obtained from the subject does not have a detectable level of pathogen associated with the respiratory disease, Quay discloses the vaccine is administered to reduce the chance the subject becomes infected with the virus (emphasis added). Therefore, instant claim 21 logically flows from Quay’s disclosure as one of ordinary skill in the art would know a sample taken from the subject prior to infection with the virus would not have a detectable level of pathogen associated with the virus.
Regarding claims 23 and 24, Quay discloses administering the composition in a single dose (Example 1, [0103]).
Regarding claim 25, Quay discloses administering the composition in two doses for subjects under 9 years of age (Example 1, [0103]).
Regarding claim 29, Quay discloses the composition is administered to the subject in the form of a nasal spray (Example 1, [0103]).
Regarding claim 31, Quay discloses the administration of the viral vaccine triggers an immune response in the subject and reduces the subject’s risk of contracting COVID-19 (Example 1, [0103]).
Regarding claims 33-40, Quay discloses the embodiments of compositions are administered to prevent an infection caused by the virus ([0020]) and the virus is a coronavirus, an influenza virus, or a combination thereof ([0021]). Quay further discloses that in some aspects, the coronavirus is SARS-CoV-2 that may comprise an alpha variant, a delta variant, or a combination thereof ([0021]). In addition, Quay discloses the influenza A H1N1 ([0035]).
While Quay discloses administration of a vaccine comprising a STING agonist as an adjuvant, Quay differs from the instantly claimed invention in that Quay does not explicitly disclose the vaccine comprises a free STING agonist. However, as discussed below, Gutjahr cures this deficiency.
Gutjahr teaches STING ligand, cGAMP, potentiates the efficacy of vaccine-induced CD8+ T cells (title). Gutjahr teaches pathogen recognition receptor (PRR) ligands, such as cGAMP, can enhance the priming process to elicit more robust adaptive immune responses via an indirect mechanism involving type I IFNs (p. 1, p. 4). Furthermore, Gatjahr teaches intranasal vaccination with 2ˈ3ˈ-cGAMP induces potent antiviral CD8+ T cells in vivo (p. 4). To confirm the utility of 2ˈ3ˈ-cGAMP as a superior adjuvant, Gutjahr vaccinated CB6F1 mice intranasally with HIV-1 Gag p24 nanoparticles (NP-p24) either alone or together with 2ˈ3ˈ-cGAMP (p. 4). Higher frequencies of tetramer+ CD8+ T cells were observed after vaccination with NP-p24 plus 2ˈ3ˈ-cGAMP relative to vaccination with NP-p24 alone (p. 6). Finally, Gutjahr teaches this discovery has unveiled new opportunities for immune modulation with the potential to revolutionize vaccine delivery (p. 6). Therefore, Gutjahr teaches that cGAMP, when administered in free (non-encapsulated) form, induces type I IFN production and enhances adaptive immune responses, including antigen-specific T cell activation, thereby confirming that free cGAMP is an effective immunostimulatory agent suitable for use in viral vaccine compositions.
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to include both nanoparticle-encapsulated cGAMP and free cGAMP in a single composition in order to achieve both (i) enhanced delivery via the nanoparticle-encapsulated cGAMP form, and (ii) immediate bioavailability and rapid immune activation/priming via the free cGAMP form. The motivation to combine arises from the well-established need in the art for new vaccine delivery strategies involving immunostimulatory agents as taught by Gutjahr. Furthermore, liposomal and nanoparticle-based drug delivery systems are well-known in the art to comprise both encapsulated and non-encapsulated drug, as encapsulation efficiency is inherently limited and release of the drug from the nanoparticle results in co-existing populations of encapsulated and free drug over time. Since Quay indicates some degradation has occurred in the formulation used in Example 2 ([0104]), the inclusion of free-cGAMP in the composition would have been an inherent or obvious feature. To the extent Applicant contents that the non-encapsulated cGAMP must be intentionally added as a separate component, such modification would have constituted routine optimization of a result-effective variable, namely the ratio of free cGAMP to encapsulated cGAMP, as a means to balance immediate and sustained immune activation, which is a well-recognized goal in the field of vaccine design.
The claimed method differs from the combined teachings of Quay and Gutjahr, if at all, only in the recitation of a non-encapsulated cGAMP component, which represents either an inherent property of liposomal formulations or, alternatively, an obvious optimization of known delivery strategies involving STING agonist. Therefore, Quay, in further view of Gutjahr, makes obvious the limitations of claims 1, 3-6, 9, 11, 14-16, 19-25, 29, 31, and 33-40.
Claims 12-13, 17, 30, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Quay and Gutjahr as applied to claims 1, 3-6, 9, 11, 14-16, 19-25, 29, 31, and 33-40 above, and further in view of Moon (cited in previous Office Action as: WO 2017/223085; published: 28 December 2017).
The disclosures of Quay and Gutjahr are set forth above. Although the combination of Quay and Gutjahr disclose a bivalent viral vaccine composition containing a negatively charged lipid nanoparticle, 2ˈ3ˈ-cGAMP (both free and encapsulated), and SARS-CoV-2 antigens, the references do not explicitly disclose the limitations of instant claims 12-13, 17, 30, and 32. However, as discussed below, Moon cures this deficiency.
Moon discloses nanoparticles associated with biomacromolecule agents configured for treating, preventing, or ameliorating various types of disorders (abstract). Specifically, Moon discloses synthetic high-density lipoprotein (sHDL) loaded with biomacromolecules (abstract) such as adjuvants and antigens (p. 106, lines 25-28). Moon discloses some embodiments whereby the antigen is a viral antigen isolated from Coronaviridae e.g., Coronavirus (p. 83, lines 1-5). Furthermore, Moon discloses some embodiments whereby the adjuvant is a STING agonist such as a cyclic dinucleotide (p. 3, lines 27-28).
Regarding claim 12, Moon discloses some embodiments allow for the antigen conjugated to the outer surface of the sHDL nanoparticle (p. 106, lines 27-28).
Regarding claim 13, Moon discloses the sHDL composition contains the immune system modulator alpha-galactosylceramide (alpha-GalCer) and describes lyophilization offers a convenient method of large-scale synthesis of sHDL loaded with alpha-GalCer (p. 126, lines 26-27; Fig. 9).
Regarding claim 17, Moon discloses a kit for delivering materials in the context of the sHDL nanoparticle embodiments that include systems that allow for the storage, transport, or delivery of such compositions and/or supporting materials such as written instructions for using the materials (p. 52, lines 14-19).
Regarding claim 30, Moon discloses the disclosed composition vaccine can be administered via inhalation (p. 111, lines 6-7).
Regarding claim 32, Moon discloses CpG activated the innate immune response and CpG triggered TLR9 activation enhances antigen-specific humoral and cellular responses to a wide variety of antigens, including peptide or protein antigens (p. 105, lines 8-13).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the instantly claimed method made obvious by a combination of Quay and Gutjahr in the following ways:
Regarding claim 12, Moon discloses the antigen in lipid-based particles may be encapsulated or associated with the outer surface. The location of the antigen within or on a lipid-based particle constitutes a result-effective variable. It is well known in the art that antigen presentation directly influences immune recognition and response. Optimization of such parameters of the composition disclosed by Quay and Gutjahr to achieve a desired immunogenic effect would have been routine and representative of a well-known design choice in vaccine delivery systems.
Regarding claim 13, Moon discloses lyophilization for lipid vaccine formulations. The selection of lyophilization constitutes routine optimization as it is well-established in the art that drying methods directly impact stability, storage, and shelf-life of lipid-based formulations. Adjusting such parameters of the composition disclosed by Quay and Gutjahr would have been well within the grasp of one of ordinary skill in the art.
Regarding claim 17, Moon discloses a kit for delivering materials in the context of the sHDL nanoparticle embodiments. Providing this kit, including instructions for use, represents routine optimization of the administration parameters associated with the method disclosed by Quay and Gutjahr. Assembly of a vaccine into a kit is standard practice in the pharmaceutical industry and well within the grasp of one of ordinary skill.
Regarding claim 30, Moon discloses an alternative, inhalation-based administration route. The route of administration constitutes a result-effective variable, as it is well-known that delivery route influences bioavailability, tissue targeting, and immune response. Optimization of the administration route, or substituting the intranasal route disclosed by Quay with the inhalation-based route disclosed by Moon, represents a simple substitution of one known element for another and would have been a routine design choice for one of ordinary skill.
Regarding claim 32, Moon discloses a genus of PRR agonists, including CPGs and STING agonists, which inherently activate innate immunity and lead to adaptive immunity. The recited functional outcome in claim 32 is an inherent property of PRR agonists, which is also explicitly taught in Gutjahr. Such effects of PRR agonists are well-understood in the art and would naturally flow from administration of the claimed composition. Therefore, this claim does not impart a patentably distinct limitation.
The claimed features in instant claims 12-13, 17, 30, and 32 relate to optimization of known variables, including antigen localization, formulation state, and routes of administration, each of which is recognized in the art to affect the performance of immunogenic compositions. Therefore, their optimization is considered to be routine and well within the grasp of one of ordinary skill and the combination of Quay, Gutjahr, and Moon make obvious that which is claimed in instant claims 12-13, 17, 30, and 32.
Claims 8 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Quay and Gutjahr as applied to claims 1, 3-6, 9, 11, 14-16, 19-25, 29, 31, and 33-40 above, and further in view of Dangi (cited in previous Office Action as: “Combining spike- and nucleocapsid-based vaccines improves distal control of SARS-COV-2,” published: 17 August 2021).
The disclosures of Quay and Gutjahr are set forth above. Although the combination of Quay and Gutjahr disclose a bivalent viral vaccine composition containing a negatively charged lipid nanoparticle, 2ˈ3ˈ-cGAMP (both free and encapsulated), and SARS-CoV-2 antigens, the references do not explicitly disclose the limitations of instant claims 8 and 26-28. However, as discussed below, Dangi cures this deficiency.
Dangi investigates whether SARS-CoV-2 vaccines containing only the spike antigen could be improved by incorporating nucleocapsid antigens (abstract). In the study, Dangi compared the efficacy of spike-based versus nucleocapsid-based vaccines after an intranasal SARS-CoV-2 challenge in K18-hACE2 mice that are highly susceptible to SARS-CoV-2 infection (p. 1). Dangi observed that only when a spike-based vaccine was co-administered with a nucleocapsid-based vaccine did protection against distal viral dissemination to the nervous system occur (p. 1). Dangi’s findings demonstrate a synergy between spike-specific and nucleocapsid-specific immune responses and provide a framework for the rational design of next-generation coronavirus vaccines (p. 1).
Regarding claim 8, Dangi teaches vaccination of mice with an adenovirus vector expression SARS-CoV-2 spike or nucleocapsid, or both (Ad5-S + Ad5-N) at a dose of 109 plaque-forming units (PFUs) per vector per mouse (p. 2).
Regarding claims 26-28, Dangi teaches the Ad5-S + Ad5-N vaccination three weeks prior to intranasal challenges with 5 x 104 PFU of SARS-CoV-2 (p. 2).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the instantly claimed method made obvious by a combination of Quay and Gutjahr in the following ways:
Regarding claim 8, Dangi teaches the combination of a spike vaccination with a nucleocapsid vaccination improves protection relative to spike-only vaccination. Further, Dangi teaches co-administration of spike/nucleocapsid antigens produces enhanced and synergistic immune responses, particularly distal protection. Dangi teaches administration in a 1:1 ratio of spike:nucleocapsid antigens, which encompasses the instantly claimed range. See MPEP 2144.05. One of ordinary skill would be motivated to modify the method of Quay and Gutjahr to include vaccination with both a spike and nucleocapsid antigen. One would be motivated to do so because Dangi teaches co-administration at a 1:1 ratio results in more effective immune protection, which is the ultimate goal of immunization.
Regarding claims 26-28, the selection of a specific time period prior to pathogen exposure represents routine optimization of a result-effective variable. It is well-known in the art that immune responses progress from the moment of administration and determining an effective pre-exposure interval would have been achieved through routine experimentation. Since immune activation kinetics are well-understood (e.g., innate vs. adaptive immunity from immunization), the selection of time before exposure is nothing more than predictable, routine timing adjustments.
The claimed features in instant claims 8 and 26-28 relate to optimization of known variables, including antigen ratios and timing of administration, which are recognized in the art to affect immunogenic outcomes. Therefore, their optimization through experimentation is considered to be routine and well within the grasp of one of ordinary skill and the combination of Quay, Gutjahr, and Dangi make obvious that which is claimed in instant claims 8 and 26-28.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Quay and Gutjahr as applied to claims 1, 3-6, 9, 11, 14-16, 19-25, 29, 31, and 33-40 above, and further in view of Dangi (previously cited) and Taussig (cited in previous Office Action as: “Antigenic Competition,” published: 1977).
The disclosures of Quay, Gutjahr, and Dangi are set forth above. Although a combination of the references discloses a bivalent viral vaccine composition containing a negatively charged lipid nanoparticle, 2ˈ3ˈ-cGAMP (both free and encapsulated), and SARS-CoV-2 spike and nucleocapsid antigens at a 1:1 ratio, the references do not explicitly disclose the limitations of instant claim 7. However, as discussed below, Taussig cures this deficiency.
Regarding instant claim 7, Dangi teaches the following: the nucleocapsid protein of SARS-CoV-2 is an important target for T cell responses (p. 3). Specifically, the nucleocapsid protein contains conserved cross-reactive T cells epitopes that are present among different coronaviruses, suggesting that it could be an ideal targe for universal coronavirus vaccines (p. 3). Furthermore, the nucleocapsid protein is among the most abundant structural proteins in the coronavirus life cycle, which may facilitate early antigen presentation and recognition by T cells (p. 4). In addition, Dangi teaches that 3 weeks post-vaccination, mice vaccinated with the combination Ad5-S + Ad5-N showed a difference in spike-specific antibody response compared to nucleocapsid-specific antibody response as shown below:
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238
416
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Greyscale
Figure 3 (p. 4)
The combination Ad5-S + Ad5-N vaccination resulted in an approximate 100-fold difference in spike-specific IgG compared to nucleocapsid-specific IgG. One of ordinary skill in the art would recognize this as a potential sign of antigenic competition between the spike protein and nucleocapsid protein.
Taussig teaches antigenic competition (title). Specifically, Taussig teaches that if a mixture of antigens is administered to an animal, immunologic interference between the components of the mixture can easily occur (p. 341). This phenomenon, called intermolecular competition, has been observed on many occasions (p. 341) and one of the features of intermolecular competition between mixed antigens is a marked dependence on the relative proportions of the antigens in the mixture (p. 342). Taussig suggests that one way to avoid intermolecular competition when mixed antigens are administered is to balance the mixture, i.e., adjust the proportions of the antigens so that competition does not occur (p. 342). This is an especially important principle, Taussig teaches, when mixed antigen vaccines are prepared for human use (p. 342).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the instantly claimed method made obvious by a combination of Quay, Gutjahr, and Dangi in the following ways:
Selection of a greater quantity of nucleocapsid antigen relative to spike antigen represents routine optimization of antigen dosing in a multivalent vaccine composition. This concept is framed by Taussig as antigenic competition, which suggests a method to overcome antigenic competition in an administered multivalent vaccine by adjusting the proportions of antigens so that competition does not occur. It is well-established in the art that varying antigen amounts and ratios influences immunogenicity, and such optimization would have been achieved through routine experimentation. Therefore, the combination of Quay, Gutjahr, Dangi, and Taussig make obvious that which is claimed in instant claim 7.
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.
Co-pending application 18/017,659
Claims 1, 24-25, 29, 30, 32-36, 39, and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29, 31-33, 38-44, and 46 of co-pending application 18/017,659 (hereinafter ‘659) in view of Gutjahr (previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a liposomal formulation containing a modulator and method of administering this formulation.
Instant Claim
‘659 Claim
Subject Matter as Made Obvious by Gutjahr
1
29
A method of administering a composition containing a lipid-based particle comprising an antigen and a pattern recognition receptor agonist modulator. Adding a free STING agonist is made obvious by Gutjahr as previously discussed.
24
43
The method administered in one dose.
25
44
The method administered in two doses.
29 and 30
42
The method administered via intranasal or inhalation.
31
46
The method is used to prevent the establishment of disease in the subject…
32
31-33
The composition of the method is suitable for developing immunity in the subject.
33
38
The method for treating or preventing a disease where the disease is caused by a pathogen.
34
39
The method wherein the pathogen is a respiratory pathogen.
35
40
The method wherein the respiratory pathogen is a virus.
36, 39-40
41
The method wherein the virus is a coronavirus (SARS-CoV), SARS-CoV-2
Therefore, claims 29, 31-33, 38-44, and 46 of co-pending application 18/017,659, in view of Gutjahr, make obvious that which is claimed in instant claims 1, 24-25, 29, 30, 32-36, 39, and 40. This is a provisional nonstatutory double patenting rejection.
Co-pending application 18/034,312
Claims 1, 3, 11, 15, 16, and 19-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 97, 99, 104, 108, 111, and 118 of co-pending application 18/034,312 (hereinafter ‘312) in view of Gutjahr (previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because the method of ‘312 is drawn to administering an identical composition to what is instantly claimed.
Instant Claim
‘312 Claim
Subject Matter as Made Obvious by Gutjahr
1
97, 99
A method of preventing or treating a disease or condition in a subject comprising administering to the subject a composition comprising a lipid-based particle and a modulator that induces activation of the STING pathway. Adding a free STING agonist is made obvious by Gutjahr as previously discussed.
15, 16
104
The composition further comprises cGAMP.
11
108
The lipid-based particle of the composition comprises DPPC, DPPG, cholesterol, and DPPE-PEG2000 in a 10:1:1:1 ratio.
19-22
111
The method further comprises administering the composition to the subject before exposure to the pathogen or after exposure of the subject to the pathogen.
3
118
The method further comprises administering an antigen.
Therefore, claims 97, 99, 104, 108, 111, and 118 of co-pending application 18/034,319, in view of Gutjahr, make obvious that which is claimed in instant claims 1, 3, 11, 15, 16, and 19-22. This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1, 3-9, 11-17, and 19-40 are rejected. No claim is allowed.
Communication
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 Julia A. Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-Th 7:30-5:30 (MST).
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/JULIA A ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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