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 are pending and currently under examination.
Priority
Acknowledgment is made of applicant's claim for priority based on a parent application
filed on 21 January 2022.
The instant application filed on 23 January 2023 is a provisional of applications 63/329,261 (filed 08 April 2022) and 63/301,918 (filed 21 January 2022) and which finds full support for the instant claims. Therefore, the effective filing date of the instant application is 21 January 2022 (the filing date of 63/301,918).
Information Disclosure Statement (IDS)
The IDS (1) filed on 06 July 2023 has been considered by the examiner. A signed copy is enclosed.
Applicant is reminded of their duty to disclose to the Office all information known to the
person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach
individual associated with the filing and prosecution of a patent application has a duty of candor
and good faith in dealing with the Office, which includes a duty to disclose to the Office all
information known to that individual to be material to patentability as defined in this section.”
Claim Interpretation
Claim 1 recites a modulator wherein the modulator is a pattern recognition receptor agonist, an activator of the immune system, or a combination thereof. Regarding the pattern recognition receptor agonist –
These agonists are defined in prior art as immunostimulatory agents targeting innate immune response pathways and triggering secretion of type I and type II IFNs.1 Furthermore, the prior art discloses several pattern recognition receptor agonists: TLR agonists, RIG-I-like receptor agonists, and STING agonists.2 Although the specification does not provide an adequate number of species representative of the breadth of genus of pattern recognition receptor agonists, a genus of these agents is disclosed in prior art.
Claim Rejections - 35 USC § 112(b)
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 26-28 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.
Claim 26 recites the limitation “the respiratory disease” in claim 18. There is insufficient antecedent basis for this limitation in the claim as claim 18 does not recite a respiratory disease. Furthermore, claim 27, which depends from claim 26, also recites the limitation “the respiratory disease” as does claim 28, which also depends from claim 26. Therefore, there is insufficient antecedent basis for the limitations contained within claims 26-28.
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)(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 1-5, 9-11, 15, 16, 18, 23-25, 29, and 31 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Quay (US 2023/0364221 A1; published: 16 November 2023; effective filing date: 15 October 2020).
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 instant 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]).
Regarding instant claim 2, Quay discloses the 2ˈ3ˈ-cGAMP adjuvant is encapsulated in a negatively charged lipid nanoparticle (Example 1, [0101]).
Regarding instant 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 instant claim 9, Quay discloses the composition is in the form of a nasal spray (Example 1, [0102]).
Regarding instant claim 10, Quay discloses the modulator of the composition, 2ˈ3ˈ-cGAMP, is a STING pathway agonist (Example 1, [0101]).
Regarding instant 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 instant claims 15 and 16, Quay discloses the composition comprises 2ˈ3ˈ-cGAMP (Example 1, [0101]).
Regarding instant claim 18, Quay discloses administering a composition comprising a lipid-based particle and 2ˈ3ˈ-cGAMP modulator (Example 1, [0103]).
Regarding instant claims 23 and 24, Quay discloses administering the composition in a single dose (Example 1, [0103]).
Regarding instant claim 25, Quay discloses administering the composition in two doses for subjects under 9 years of age (Example 1, [0103]).
Regarding instant claim 29, Quay discloses the composition is administered to the subject in the form of a nasal spray (Example 1, [0103]).
Regarding instant 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]).
Therefore, and based on the above evidence, Quay anticipates what is currently claimed in instant claims 1-5, 9-11, 15, 16, 18, 23-25, 29, and 31.
Claims 1, 2, 18, 20, 23, and 24 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Tam (US 9,820,940 B2; date of patent: 21 November 2017).
Tam discloses liposomal formulations of polymyxin B and pharmaceutical compositions thereof useful for the treatment of bacterial infections (abstract).
Regarding instant claims 1 and 2, Tam discloses a composition comprising polymyxin B encapsulated in liposomes (col. 12, lines 1-4).
Regarding instant claim 18, Tam discloses administering the composition comprising polymyxin B encapsulated in liposomes to mice (col. 12, lines 26-27).
Regarding instant claim 20, Tam discloses a study where mice were exposed to a bacterial pathogen strain, multiple drug-resistant Pseudomonas aeruginosa, which causes lung disease (col. 11, lines 56-61). Two hours after exposure, certain treatment groups were administered polymyxin B liposomes (col. 13, lines 36-58) and lungs were collected for analysis (col. 13, lines 44-47). At the start of therapy, the animals had between 3.1 to 3.6 log10 cfu/g in lung tissues.
Regarding instant claims 23 and 24, Tam discloses administering the composition in a single dose (col. 12, lines 26-29).
Therefore, and based on the above evidence, Tam anticipates what is currently claimed in instant claims 1, 2, 18, 20, 23, and 24.
Claims 1-4, 13, 15, 18-19, 23-25, and 31-32 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Moon (WO 2017/223085; published: 28 December 2017).
Moon discloses nanoparticles associated with biomacromolecule agents configured for treating, preventing, or ameliorating various types of disorders (abstract).
Moon’s disclosed Examples (beginning on p. 119) describes the materials and methods for synthesis of a synthetic high-density lipoprotein (sHDL) loaded with biomacromolecules.
Regarding instant claim 1, Moon discloses a composition comprising tumor antigen peptides, DMPC and DOPE-PDP, loaded into sHDL (p. 120, lines 25-28). Furthermore, cytosine-guanine (CpG) was loaded into sHDL (p. 121, lines 9-11).
Regarding instant claim 2, Moon discloses the CpG was loaded into the sHDL (p. 121, lines 9-11).
Regarding instant claims 3 and 4, Moon discloses the composition comprises tumor antigen peptides that are loaded to sHDL (p. 120, lines 2-4 and lines 25-28).
Regarding instant 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 instant claim 15, Moon discloses the composition contains nucleotide modulator CpG (p. 121, lines 9-11).
Regarding instant claim 18, in various examples, Moon discloses immunization of mice with the sHDL-antigen peptide-CpG formulation (see, for example, p. 135, lines 9-31).
Regarding instant claim 19, Moon discloses the healthy female C57BL/6 mice were inoculated with tumor cells and monitored for tumor growth (p. 135, lines 9-20; 32-35).
Regarding instant claims 23 and 24, Moon discloses immunization of mice with the sHDL-antigen peptide-CpG formulation a single time before euthanizing and harvesting the lymph nodes (p. 135, lines 25-31).
Regarding instant claim 25, Moon discloses immunization of mice with the sHDL-antigen peptide-CpG formulation on days 10, 17, and 24 (p. 136, lines 2-5).
Regarding instant claim 31, Moon discloses the immunization of mice with a formulation containing some form of sHDL and CpG reduces slows disease progression by reducing tumor growth (See, for example, Fig. 7; p. 126, lines 18-19; and p. 130, lines 1-3).
Regarding instant 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).
Therefore, and based on the above evidence, Moon anticipates what is currently claimed in instant claims 1-4, 13, 15, 18-19, 23-25, and 31-32.
Claims 1-3, 9-12, 14-16, 18-19, 23-26, 29, 31-36, and 39-40 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Varadarajan (US 2025/0195638 A1; published: 19 June 2025; effective filing date: 03 November 2020).
Varadarajan discloses compositions and methods for the prevention of pathogens wherein the composition comprising a liposome used to encapsulate one or more STING agonists (abstract). Varadarajan, in the examples, further discloses the preparation and characterization of lipid-based particles, comprising a STING agonist modulator and a spike protein antigen, useful in compositions for treating or preventing a disease (e.g., respiratory disease) in a subject ([0161]).
Regarding instant claims 1, 2, 3, 10, and 12, Varadarajan discloses the STING agonist encapsulated with negatively charged liposomes to yield compositions comprising a liposome, a STING agonist modulator, and an antigen associated with the surface of the liposome ([0161], Fig. 1).
Regarding instant claims 9 and 29, Varadarajan discloses mice were treated by intranasal administration with spike protein trimer antigen absorbed onto liposomes encapsulating a STING agonist modulator ([0174]).
Regarding instant claim 11, Varadarajan discloses the liposomes were composed of a molar ratio of 10:1:1:1 of DPPC, DPPG, cholesterol, and DPPE-PEG2000 ([0162]).
Regarding instant claim 14, Varadarajan discloses the composition containing cGAMP and liposomes is in liquid form ([0162]).
Regarding instant claims 15 and 16, Varadarajan discloses the STING agonist modulator is cGAMP ([0162]).
Regarding instant claim 18, Varadarajan discloses mice were treated with cGAMP-antigen-liposome compositions ([0171]).
Regarding instant claims 19, 25, 26, 33, 34, 35, 36, 39, and 40, Varadarajan discloses hamsters treated intranasally with a composition comprising cGAMP STING agonist modulator encapsulated within a nanoparticle comprising a 10:1:1:1 ratio of DPPC, DPPG, cholesterol, and DPPE-PEG2000 at 24 hours and 6 hours before infection with TCID50B.1.1.7 (alpha variant of coronavirus) ([0231]).
Regarding instant claims 23 and 24, Varadarajan discloses the mice were administered a single dose of the composition ([0172]).
Regarding instant claim 31, Varadarajan discloses administration with cGAMP-antigen-liposome compositions resulted in preventing initial establishment of infection ([0187]).
Regarding instant claim 32, Varadarajan discloses administration with cGAMP-antigen-liposome compositions resulted in local inductive responses within the respiratory tract leading to durable local immunity against inhaled pathogens ([0181]).
Therefore, and based on the above evidence, Varadarajan anticipates what is currently claimed in instant claims 1-3, 9-12, 14-16, 18-19, 23-26, 29, 31-36, and 39-40.
Claims 1-3, 9, 10, 12, 15, 16, 18, 19, 26, 29, 33-36, 39, and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by An (“Single-dose intranasal vaccination elicits systemic and mucosal immunity against SARS-CoV-2,” preprint published: 23 July 2020).
An discloses a single-dose intranasal vaccination which elicits systemic and mucosal immunity against SARS-CoV-2 (title).
Regarding instant claims 1, 2, 10, 15, and 16, An discloses a vaccine formulation against SARS-CoV-2 where the STING agonist cGAMP is encapsulated in liposomes (‘Introduction,’ p. 4).
Regarding instant claims 3 and 9, An discloses cGAMP encapsulated in liposomes is used as an adjuvant for intranasal vaccination with the trimeric or monomeric versions of the S protein (‘Introduction,’ p. 4).
Regarding instant claim 12, An discloses the absorption of the S protein antigen on the liposome (‘Results,’ p. 5) as shown below:
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(Fig. 1A, p. 18).
Regarding instant claims 18, 19, 26, 29, 33-36, 39, and 40, An discloses administering the composition of the protein and adjuvant (S protein trimer-cGAMP) to healthy BALB/c mice via intranasal administration (‘Results,’ p. 5).
Therefore, and based on the above evidence, An anticipates what is currently claimed in instant claims 1-3, 9, 10, 12, 15, 16, 18, 19, 26, 29, 33-36, 39, and 40.
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 6, 14, 19, 21, 22, 33-40 are rejected under 35 U.S.C. 103 as being unpatentable over Quay (previously cited in this Office Action).
The disclosures in Quay are discussed above. Specifically, 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 further discloses certain embodiments of the viral vaccine. 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 instant 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 instant 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 instant 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 instant 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]).
Quay discloses embodiments that correspond to the currently claimed limitations in instant claims 6, 14, 19, 21, 22, 33-40. As such, it would have been prima facie obvious, before the effective filing date of the claimed invention, to use the disclosed embodiments of Quay to arrive at the claimed invention. One of ordinary skill, armed with the disclosed embodiments of Quay, could easily arrive at the currently claimed invention with a predicted success because Quay teaches the disclosed compositions and methods as being successful in inoculating a subject against coronavirus and/or influenza virus.
Claims 12, 17, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Quay (previously cited in this Office Action) in further view of Moon (previously cited in this Office Action).
The disclosures of Quay and Moon are set forth above.
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).
Regarding instant 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 instant 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 instant claim 30, Moon discloses the disclosed composition vaccine can be administered via inhalation (p. 111, lines 6-7).
A combination of Quay and Moon teach the limitations of instant claims 12, 17, and 30. Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to use the combined teachings of the references to arrive at the claimed invention. Both Quay and Moon disclose a composition containing lipid-based particles, a modulator, and an antigen and a method of using this composition to treat viruses. While Quay does not explicitly disclose simple variations of the base composition/method, such as including the composition in a kit or administering the composition via inhalation, Moon teaches success with these embodiments. Therefore, one of ordinary skill would have predicted the prior art elements are capable of being combined and the combination would have worked for its intended purpose to treat viruses.
Claims 8 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Quay (previously cited in this Office Action) in further view of Dangi (NPL: “Combining spike- and nucleocapsid-based vaccines improves distal control of SARS-COV-2,” published: 17 August 2021).
The disclosures of Quay are set forth above. Although Quay discloses a bivalent viral vaccine composition containing a negatively charged lipid nanoparticle, 2ˈ3ˈ-cGAMP, and SARS-CoV-2 antigens, Quay does not explicitly disclose the limitations of instant claims 8 and 26-28.
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 instant 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 instant 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).
A combination of Quay and Dangi teach the limitations of instant claims 8 and 26-28. Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to use the combined teachings of the references to arrive at the claimed invention. Quay discloses composition containing lipid-based particles, a modulator, and an antigen and a method of using this composition to treat viruses, but does not explicitly disclose specific antigen combinations or dosing. Dangi teaches a similar composition with specific antigen combinations and dosing schedules to provide a framework for the rational design of next-generation coronavirus vaccines. Therefore, one of ordinary skill, armed with the teachings of Dangi, could have enhanced the composition disclosed by Quay with predictable results. One would have been motivated to do so because Dangi calls for improvements for next-generation coronavirus vaccines to achieve broader protection against the virus.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Quay (previously cited in this Office Action) in further view of Dangi (previously cited in this Office Action) and Taussig (“Antigenic Competition,” published: 1977).
The disclosures of Quay are set forth above. Although Quay and Dangi collectively teach a bivalent viral vaccine composition containing a negatively charged lipid nanoparticle, 2ˈ3ˈ-cGAMP, and SARS-CoV-2 spike and nucleocapsid antigens at a 1:1 ratio, neither reference explicitly discloses the limitation of instant claim 7.
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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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).
A combination of Quay, Dangi, and Taussig teach the limitations of instant claim 7. Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to use the combined teachings of the references to arrive at the claimed invention. Quay discloses composition containing lipid-based particles, a modulator, and an antigen and a method of using this composition to treat viruses, but does not explicitly disclose specific antigen combinations or dosing. Dangi teaches a similar composition with specific antigen combinations and dosing schedules to provide a framework for the rational design of next-generation coronavirus vaccines. However, the results disclosed by Dangi after vaccine administration teach a potential antigenic competition between the spike protein and nucleocapsid protein. Taussig teaches methods to avoid antigenic competition in mixed antigen vaccines by adjusting the proportions of the antigens so competition does not occur. The results of Dangi suggest the nucleocapsid protein produces a diminished response when mixed with a spike protein. Therefore, armed with the teachings of Taussig, one of ordinary skill would predict that an increase in nucleocapsid proteins in the nucleocapsid-spike protein mixture would result in less antigenic competition and a more balanced immune response. Therefore, one of ordinary skill, armed with the teachings of Dangi and Taussig, could have enhanced the composition disclosed by Quay with predictable results. One would have been motivated to do so because Dangi calls for improvements for next-generation coronavirus vaccines to achieve broader protection against the virus.
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.
US Patent 9,820,940 B2
Claims 1, 2, 18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 5 of U.S. Patent No. 9,820,940 B2 (hereinafter ‘940). 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
‘940 Claim
Subject Matter Anticipated by ‘940
1
1
A composition comprising a lipid-based particle and immune system activator modulator.
2
1
The modulator is encapsulated within the lipid-based particle.
18
4
A method involving administering the composition comprising a lipid-based particle and immune system activator modulator.
20
5
The subject has a detectable level of a respiratory disease (“a method of treating a bacterial infection in a subject in need of such treatment wherein the bacteria causing the infection is Legionella pneumonophilia”).
Therefore, claims 1, 4, and 5 of U.S. Patent No. 9,820,940 B2 anticipate instant claims 1, 2, 18, and 20.
Claims 3-6, 9-11, 14-16, 19, 21-25, 29, 31, and 33-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 5 of U.S. Patent No. 9,820,940 B2 in view of Quay (previously cited in this Office Action).
The disclosures of Quay are previously discussed. While ‘940 claims a composition and method of treating a respiratory bacterial infection using a liposomal vesicle that encapsulates a modulator (immune system activator), Quay discloses a method of treating a viral respiratory disease using a liposomal vesicle that encapsulates a modulator (immune system activator). Quay further discloses each of the limitations set forth in instant claims 3-6, 9-11, 14-16, 19, 21-25, 29, 31, and 33-40. Therefore, the instant claims are made obvious over ‘940 in view of Quay because one of ordinary skill in the art could easily manipulate the formulation and method disclosed in ‘940 to target a viral respiratory disease. This is a prima facie case of obviousness because both Quay and the instant application are directed to a viral respiratory disease and one of ordinary skill in the art could easily substitute that which is claimed by ‘940 with the embodiments disclosed by Quay as being successful in treating a viral respiratory disease (particularly coronavirus and influenza).
Claims 12, 13, 17, 30, and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 5 of U.S. Patent No. 9,820,940 B2 in view of Quay (previously cited in this Office Action) and Moon (previously cited in this Office Action).
The disclosures of Quay and Moon are previously discussed. While ‘940 claims a composition and method of treating a respiratory bacterial infection using a liposomal vesicle that encapsulates a modulator (immune system activator), Quay and Moon disclose a method of treating a viral respiratory disease using a liposomal vesicle that encapsulates a modulator (immune system activator). Moon further discloses each of the limitations set forth in instant claims 12, 13, 17, 30, and 32. Therefore, the instant claims are made obvious over ‘940 in view of Quay and Moon because one of ordinary skill in the art could easily manipulate the formulation and method disclosed in ‘940 to target a viral respiratory disease. This is a prima facie case of obviousness because both Quay, Moon, and the instant application are directed to a viral respiratory disease and one of ordinary skill in the art could easily substitute that which is claimed by ‘940 with the embodiments disclosed by Quay and Moon as being successful in treating a viral respiratory disease.
Claims 8 and 26-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 5 of U.S. Patent No. 9,820,940 B2 in view of Quay (previously cited in this Office Action) and Dangi (previously cited in this Office Action).
The disclosures of Quay and Dangi are previously discussed. While ‘940 claims a composition and method of treating a respiratory bacterial infection using a liposomal vesicle that encapsulates a modulator (immune system activator), Quay and Dangi disclose a method of treating a viral respiratory disease using a liposomal vesicle that encapsulates a modulator (immune system activator) with spike and nucleocapsid antigens. Dangi further discloses each of the limitations set forth in instant claims 8 and 26-28. Therefore, the instant claims are made obvious over ‘940 in view of Quay and Dangi because one of ordinary skill in the art could easily manipulate the formulation and method disclosed in ‘940 to target a viral respiratory disease. This is a prima facie case of obviousness because both Quay, Dangi, and the instant application are directed to a viral respiratory disease and one of ordinary skill in the art could easily substitute that which is claimed by ‘940 with the embodiments disclosed by Quay and Dangi as being successful in treating a viral respiratory disease.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 5 of U.S. Patent No. 9,820,940 B2 in view of Quay (previously cited in this Office Action), Dangi (previously cited in this Office Action), and Taussig (previously cited in this Office Action).
The disclosures of Quay, Dangi, and Taussig are previously discussed. While ‘940 claims a composition and method of treating a respiratory bacterial infection using a liposomal vesicle that encapsulates a modulator (immune system activator), Quay and Dangi disclose a method of treating a viral respiratory disease using a liposomal vesicle that encapsulates a modulator (immune system activator) with spike and nucleocapsid antigens. Taussig further discloses each of the limitations set forth in instant claim 7, especially in light of the experimental data obtained by Dangi. Therefore, the instant claims are made obvious over ‘940 in view of Quay, Dangi, and Taussig because one of ordinary skill in the art could easily manipulate the formulation and method disclosed in ‘940 to target a viral respiratory disease. This is a prima facie case of obviousness because both Quay, Dangi, and the instant application are directed to a viral respiratory disease and one of ordinary skill in the art could easily substitute that which is claimed by ‘940 with the embodiments disclosed by Quay and Dangi as being successful in treating a viral respiratory disease. Furthermore, one of ordinary skill would be motivated to adjust the composition disclosed by Quay and Dangi because the data suggests potential interference with the mixed antigen composition and Taussig provides rationale to alter the ratio of antigens within the composition.
Co-pending application 18/017,659
Claims 1, 5, 6, 9-13, 18-20, 23-25, 29-32, 34-36, 39, and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, 11, 12, 14, 23, 29, 33, 37, 39-44, and 46 of co-pending application 18/017,659 (hereinafter ‘659). 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 Anticipated by ‘659
1
1
A composition comprising a lipid-based particle and a pattern recognition receptor agonist modulator.
5
11
The composition further comprises an antigen and the antigen is a spike protein or portion thereof.
6
12
The composition further comprises an antigen and the antigen is a nucleocapsid protein or portion thereof.
10
14
The modulator of the composition is an agonist of the STING pathway.
11
6
The lipid-based particle of the composition comprises DPPC, DPPG, cholesterol, and DPPE-PEG2000 in a 10:1:1:1 ratio.
12
8
The antigen of the composition is associated with the outer surface of the lipid-based particle.
13
23
The composition is lyophilized.
18
29
A method involving administering the composition comprising a lipid-based particle and pattern recognition receptor agonist modulator.
19
29
The subject does not have a detectable level of a pathogen associated with the respiratory disease (“a method of preventing…”).
20
29
The subject has a detectable level of a respiratory disease (“a method of treating…”).
23
43
The composition is administered in at least one dose.
24
43
The composition is administered in one dose.
25
44
The composition is administered in two doses.
9, 29
42
The composition is administered through intranasal administration.
30
42
The composition is administered through inhalational administration.
31
46
The method of administering the composition is used to prevent the establishment of the disease in the subject, to prevent progression of the disease in the subject, to prevent the transmission of disease to a second subject, or combinations thereof.
32
33, 37
The method initiates an innate immune response that leads to associated adaptive immunity.
34
39
The pathogen is a respiratory pathogen.
35
40
The respiratory pathogen is a virus.
36
41
The virus is a coronavirus.
39
41
The virus is a coronavirus.
40
41
The virus is SARS-CoV-2.
Therefore, claims 1, 6, 8, 11, 12, 14, 23, 29, 33, 37, 39-44, and 46 of co-pending application 18/017,659 anticipate instant claims 1, 5, 6, 9-13, 18-20, 23-25, 29-32, 34-36, 39, and 40. This is a provisional nonstatutory double patenting rejection.
Claims 2-4, 14-16, 21, 22, 33, and 37-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, 11, 12, 14, 23, 29, 33, 37, 39-44, and 46 of co-pending application 18/017,659 in view of Quay (previously cited in this Office Action).
The disclosures of Quay are previously discussed. Both ‘659 and Quay disclose a method of treating a viral respiratory disease using a liposomal vesicle that encapsulates a modulator (immune system activator). Quay further discloses each of the limitations set forth in instant claims 2-4, 14-16, 21, 22, 33, and 37-38. Therefore, the instant claims are made obvious over ‘659 in view of Quay because one of ordinary skill in the art could easily manipulate the formulation and method disclosed in ‘659 to target a viral respiratory disease. This is a prima facie case of obviousness because both Quay and the instant application are directed to a viral respiratory disease and one of ordinary skill in the art could easily substitute that which is claimed by ‘659 with the embodiments disclosed by Quay as being successful in treating a viral respiratory disease (particularly coronavirus and influenza).
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, 11, 12, 14, 23, 29, 33, 37, 39-44, and 46 of co-pending application 18/017,659 in view of Quay (previously cited in this Office Action) and Moon (previously cited in this Office Action).
The disclosures of Quay and Moon are previously discussed. Both ‘659, Quay, and Moon disclose a method of treating a viral respiratory disease using a liposomal vesicle that encapsulates a modulator (immune system activator). Moon further discloses each of the limitations set forth in instant claim 17. Therefore, the instant claims are prima facie obvious over ‘659 in view of Quay and Moon because one of ordinary skill in the art could easily manipulate the formulation and method disclosed in ‘659 to encompass the formulation in a kit.
Claims 8 and 26-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, 11, 12, 14, 23, 29, 33, 37, 39-44, and 46 of co-pending application 18/017,659 in view of Quay (previously cited in this Office Action) and Dangi (previously cited in this Office Action).
The disclosures of Quay and Dangi are previously discussed. The combination of ‘659, Quay, and Dangi disclose a method of treating a viral respiratory disease using a liposomal vesicle that encapsulates a modulator (immune system activator) with spike and nucleocapsid antigens. Dangi further discloses each of the limitations set forth in instant claims 8 and 26-28. Therefore, the instant claims are prima facie obvious over ‘659 in view of Quay and Dangi because one of ordinary skill in the art could easily manipulate the formulation and method disclosed in ‘659 with the embodiments disclosed by Quay and Dangi as being successful in treating a viral respiratory disease to arrive at the currently claimed invention.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, 11, 12, 14, 23, 29, 33, 37, 39-44, and 46 of co-pending application 18/017,659 in view of Quay (previously cited in this Office Action), Dangi (previously cited in this Office Action), and Taussig (previously cited in this Office Action).
The disclosures of Quay, Dangi, and Taussig are previously discussed. A combination of ‘659, Quay, and Dangi disclose a method of treating a viral respiratory disease using a liposomal vesicle that encapsulates a modulator (immune system activator) with spike and nucleocapsid antigens. Taussig further discloses the limitations set forth in instant claim 7, especially in light of the experimental data obtained by Dangi. Therefore, the instant claims are prima facie obvious over ‘659 in view of Quay, Dangi, and Taussig because one of ordinary skill in the art could easily manipulate the formulation and method disclosed in ‘659 to target a viral respiratory disease and adjust the composition disclosed by Quay and Dangi. One would have been motivated to do so because the experimental data taught by Dangi suggests potential interference with the mixed antigen composition and Taussig provides rationale to alter the ratio of antigens within the composition.
Co-pending application 18/034,312
Claims 1, 3, 10, 11, 15, 16, and 18-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 97, 99, 104, 108, 111, and 118-120 of co-pending application 18/034,312 (hereinafter ‘312). 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 Anticipated by ‘312
1, 10, 18
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.
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.
1, 3, 10, 18
119, 120
A composition comprising a modulator that induces the STING pathway in a subject and further comprises an antigen.
Therefore, claims 97, 99, 104, 108, 111, and 118-120 of co-pending application 18/034,312 anticipate instant claims 1, 3, 10, 11, 15-, 16, and 18-22. This is a provisional nonstatutory double patenting rejection.
Claims 2, 4-6, 9, 14, 23-25, 29, 31, and 33-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 97, 99, 104, 108, 111, and 118-120 of co-pending application 18/034,312 in view of Quay (previously cited in this Office Action).
The disclosures of Quay are previously discussed. Both ‘312 and Quay disclose a method of treating a disease using a liposomal vesicle that encapsulates a modulator (immune system activator). Quay further discloses each of the limitations set forth in instant 2, 4-6, 9, 14, 23-25, 29, 31, and 33-40. Therefore, the instant claims are made obvious over ‘312 in view of Quay because one of ordinary skill in the art could easily manipulate the formulation and method disclosed in ‘312 to target a viral respiratory disease. This is a prima facie case of obviousness because both Quay and the instant application are directed to a viral respiratory disease and one of ordinary skill in the art could easily substitute that which is claimed by ‘312 with the embodiments disclosed by Quay as being successful in treating a viral respiratory disease (particularly coronavirus and influenza).
Claims 12, 13, 17, 30, and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 97, 99, 104, 108, 111, and 118-120 of co-pending application 18/034,312 in view of Quay (previously cited in this Office Action) and Moon (previously cited in this Office Action).
The disclosures of Quay and Moon are previously discussed. Both ‘312, Quay, and Moon disclose a method of treating a disease using a liposomal vesicle that encapsulates a modulator (immune system activator). Moon further discloses each of the limitations set forth in instant claims 12, 13, 17, 30, and 32. Therefore, the instant claims are prima facie obvious over ‘312 in view of Quay and Moon because one of ordinary skill in the art could easily manipulate the formulation and method disclosed in ‘312 to encompass those variations disclosed by Quay and Moon.
Claims 8 and 26-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 97, 99, 104, 108, 111, and 118-120 of co-pending application 18/034,312 in view of Quay (previously cited in this Office Action) and Dangi (previously cited in this Office Action).
The disclosures of Quay and