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 .
Applicant’s response of 05/05/2026, including replacement drawing sheets, has been received and entered into the application file.
Claims 1, 2, 6, 7, 10, and 11 were amended in the claim set filed 05/05/2026.
Claims 3, 4, 8, 9, and 12 were canceled in the claim set filed 05/05/2026.
Claims 1, 2, 5-7, 10, 11, 13, and 14 are pending, of which claim 14 was previously withdrawn.
Accordingly, claims 1, 2, 5-7, 10, 11, and 13 are pending and under consideration.
Status of Prior Objections/Rejections
RE: Election/Restrictions
Applicant's previous election with traverse of Group I (claims 1-13) in the reply filed on 01/07/2026 is acknowledged. The traversal was on the grounds that Group I is directed to an immunogenic composition comprising an mRNA antigen and a kinetically controllable immune modulator as active ingredients specifically configured to increase an immune response, while Group II (claim 14) is directed to a method that defines the process by which the immune response enhancement is manifested upon administration of the immunogenic composition of claim 1 (Group I), which is inherent in the immunogenic composition of claim 1 (Group I).
The requirement was still deemed proper and was therefore made FINAL, as set forth in the non-final rejection dated 02/06/2026.
Claim 14 stands withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/07/2026.
Accordingly, claims 1-13 were pending and under consideration, of which claims 3, 4, 8, 9, and 12 were subsequently cancelled in the claim set filed 05/05/2026. Accordingly, claims 1, 2, 5-7, 10, 11, and 13 are pending and under consideration.
RE: Drawings
►The drawings were previously objected to for various minor informalities:
The replacement drawings filed 05/05/2026 have obviated the basis of the objections of record. The objections of record are hereby withdrawn.
RE: Claim Objections
►Claims 1-3, 6-7, and 11-12 were previously objected to for various informalities.
The cancellation of claims 3 and 12 render the objections thereof moot.
The amendments filed 05/05/2026 have obviated the basis of the objections of record. The objections of record are hereby withdrawn.
However, further review of the instant claim set has necessitated new grounds of objection, which are set forth below.
RE: Claim Rejections - 35 USC § 112(a)
►Claims 1-13 were previously rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The cancellation of claims 3, 4, 8, 9, and 12 renders the rejection thereof moot.
The amendments filed 05/05/2026 have obviated the basis of the rejection of record. The rejection of record is hereby withdrawn.
►Claim 13 was previously rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Applicant has traversed the rejection of record, asserting that enablement does not require a working example and experimentation is allowed so long as it is not undue. Applicant further asserts that the core of the present invention relates to an immunogenic composition for an mRNA vaccine that is intended to enhance the efficacy of said mRNA vaccine.
In response, this is found persuasive. Accordingly, the rejection of record is hereby withdrawn.
RE: Claim Rejections - 35 USC § 112(b)
►Claims 1-13 were previously 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.
The cancellation of claims 3, 4, 8, 9, and 12 renders the rejection thereof moot.
The amendments filed 05/05/2026 have obviated the basis of the rejection of record. The rejection of record is hereby withdrawn.
However, new grounds of rejection necessitated by amendment are set forth below.
RE: Claim Rejections - 35 USC § 103
►Claims 1-13 were previously rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0351040 A1 (hereinafter Valiante; of record), US 2019/0151462 A2 (hereinafter Coffman; as cited in the IDS filed 05/10/2023; of record), and Abraham et al., 2017 (hereinafter Abraham), as evidenced by Kaczanowska et al., 2013 (hereinafter Kaczanowska).
The cancellation of claims 3, 4, 8, 9, and 12 renders the rejection thereof moot.
Applicant has traversed the rejection of record, asserting that the present invention is directed to overcoming the limitations of mRNA vaccines caused by the inherent translational vulnerability of mRNA encoding an antigen, which is a fundamental problem of mRNA vaccines that have recently been extensively studied. Per Applicant, the present invention aims to provide a novel system of an mRNA vaccine capable of achieving optimal effects by effectively controlling the expression mechanism of an antigen and immunogenicity, which have mutually opposed actions. Applicant has provided extensive experimental documentation detailing that the instant invention significantly increases the efficacy of mRNA vaccines by establishing a difference in the time points of action of the mRNA encoded antigen and the TLR agonists. Applicant asserts that Valiante does not consider the interaction between the time point of expression of the mRNA antigen and the time point of the immune modulator and further that there is no motivation to combine the teachings of Valiante with those of Coffman, which is silent as to the essential role of NH2 conjugation.
In response, while it is found persuasive that Coffman is silent as to the essential role of NH2 conjugation, the essential role of the NH2 group is known in the art (disclosed in Ryu et al., 2014; set forth in detail below). Furthermore, regarding Applicant’s assertion that there is no motivation to combine the teachings of Valiante with those of Coffman, as previously set forth, Coffman discloses that cleavable linkers promote local release and/or local retention of a bioactive form of the TLR7/8 agonist administered therein and also stimulate an effective immune response (abstract; paragraphs [0002] and [0008]). Coffman specifically discloses that the subject matter taught therein relates to methods for preparation of a therapeutic agent or vaccine adjuvant (paragraphs [0158] and [0401]) capable of targeting specific tissues, thereby reducing unwanted systemic immune activation (paragraph [0007]). Additionally, Coffman explicitly discloses that the cleavable, self-eliminating linkers taught therein maintain the TLR7/8 agonist in a relatively inactive state prior to cleavage of said linker, after which the TLR7/8 agonist is released in its active form (paragraphs [0006] and [0364]). Therefore, the instant invention cannot be considered novel and unpredictable over the prior art, as the prior art teaches all the components of the instantly claimed invention and sets forth motivation for combining all said components.
However, given that Coffman is silent as to the essential role of NH2 conjugation, the rejection of record is hereby withdrawn with new grounds of rejection necessitated by amendment set forth in detail below.
RE: Double Patenting
►Claims 1, 4, 6-10, and 13 were previously provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-12, and 17 of copending Application No. 17/391,224 (reference application; corresponds to US 2022/0008411 A1). Although the claims at issue are not identical, they are not patentably distinct from each other, as set forth below.
The cancellation of claims 4, 8, and 9 renders the rejection thereof moot.
Applicant has traversed the rejection of record, asserting that the present claim set is distinct from that of application ‘224, as application ‘224 does not disclose any difference in the timing between the mRNA and the TLR7/8 agonist.
In response, this is not found persuasive. As an initially matter and as preciously set forth, recovery of TLR 7/8 agonist kinetic activity is recited to occur within 4 days at copending claim 6 and further that said TLR 7/8 agonist may be part of a vaccine composition comprising said agonist and an antigenic polynucleotide at copending claims 10 and 11. However, the amendments to the instant claim set have necessitated new grounds of rejection, which are set forth in detail below.
►Claims 1, 4, 6-10, and 12-13 were previously provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6, 8-12, and 14-15 of copending Application No. 17/909,066 (reference application; corresponds to US 2023/0346924 A1). Although the claims at issue are not identical, they are not patentably distinct from each other, as set forth below.
The cancellation of claims 4, 8, 9, and 12 renders the rejection thereof moot.
Applicant has traversed the rejection of record, asserting that application ‘066 does not disclose any difference in the timing between the mRNA and the TLR7/8 agonist.
In response, this is not found persuasive. As an initial matter and as previously set forth, copending claim 12 recites that the antigen of the vaccine composition claimed therein includes an antigen such as a polynucleotide, which reads on the instantly claimed mRNA-encoded antigen. Furthermore, copending claim 6 recites that the TLR7/8 agonist is cleaved in response to a tumor microenvironment, or enzymes and pH of endosomes and lysosomes in cells such that the active site of the toll-like receptor 7 or 8 agonist is exposed so that a kinetic function is recovered within 4 days. However, the amendments to the instant claim set have necessitated new grounds of rejection, which are set forth in detail below.
►Claims 1, 4-6, 8-9, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-9, 14, and 16 of copending Application No. 18/040,323 (reference application; corresponds to US 2023/0277525 A1). Although the claims at issue are not identical, they are not patentably distinct from each other, as set forth below.
The cancellation of claims 4, 8, and 9 renders the rejection thereof moot.
Applicant has traversed the rejection of record, asserting that application ‘328 does not disclose any difference in the timing between the mRNA and the TLR7/8 agonist.
In response, upon review of the amendments to application ‘328 filed 06/30/2026, the rejection of record is hereby withdrawn.
►Claims 1, 3, and 4-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 14-17 of copending Application No. 18/040,328 (corresponds to US 2023/0355750 A1) in view of US 2019/0351040 A1 (hereinafter Valiante; of record) and Abraham et al., 2017 (hereinafter Abraham).
The cancellation of claims 8, 9, and 12 renders the rejection thereof moot.
Applicant has traversed the rejection of record, asserting that application ‘328 does not disclose any difference in the timing between the mRNA and the TLR7/8 agonist.
In response, this is not found persuasive. As an initial matter and as previously set forth, copending claim 16 recites that the antigen of the adjuvant ensemble composition may be a polynucleotide, which reads on the instantly claimed mRNA-encoded antigen. Furthermore, copending claim 2 recites kinetic control of the activity of the claimed second adjuvant, which may be a toll-like receptor agonist per copending claim 11. However, the amendments to the instant claim set have necessitated new grounds of rejection, which are set forth in detail below.
New/Maintained Grounds of Objection/Rejection
Claim Objections
Claims 1 and 2 are objected to because of the following informalities:
Claim 1 recites in part that “the toll-like receptor 7 or 8 agonist is any one or more selected from the group consisting of imidazoquinoloine-based agonist…” (bolded emphasis added), which appears to be a simple typographical error meant to recite “imidazoquinoline,” as disclosed at page 14, lines 20 and 22 and page 23, line 20 of the instant specification. It would be remedial to amend the instant claim to correct this typographical error.
With further regard to claim 1, the recitation of “wherein the immune modulator is toll-like receptor 7 or 8 agonist” does not comport with standard grammatical and/or linguistic conventions, as there is no article such as “a” preceding the instantly claimed “toll-like receptor 7 or 8 agonist.” It would be remedial to amend the instant claim to include an article such as “a” preceding the instantly claimed “toll-like receptor 7 or 8 agonist.”
Claim 2 recites in part “translation of mRNA into a protein proceeds after administration of the immunogenic composition,” which is phrased poorly such that claim interpretation is hampered. While there is an mRNA species recited in claim 1, the phrasing of claim 2 does not properly mirror this recitation, introducing lack of clarity. It would be remedial to amend the instant claim such that its phrasing mirrors the recitation of claim 1, for example by reciting “translation of the mRNA-encoded antigen into a protein proceeds after administration of the immunogenic composition.” This is merely an example set forth by the Examiner and is not intended to be limiting.
Appropriate correction is required.
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 1, 2, 5-7, 10, 11, and 13 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 1 recites the limitation "the NH2 group" in line 4. There is insufficient antecedent basis for this limitation in the claim. Furthermore, claims 2, 5-7, 10, 11, and 13 do not remedy the lack of antecedent basis of claim 1 and therefore inherit the rejection of claim 1. It would be remedial to amend the instant claim set such that there is sufficient antecedent basis for each and every claim term, for example by reciting “…wherein the kinetically controllable immune modulator is bound to a cleavable linker at a critical moiety of the immune modulator, wherein the critical moiety is an NH2 group…”. This is merely an example set forth by the Examiner and is not intended to be limiting.
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.
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, 2, 5-7, 10, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0351040 A1 (hereinafter Valiante; of record), US 2019/0151462 A1 (hereinafter Coffman; as cited in the IDS filed 05/10/2023; of record), Abraham et al., 2017 (hereinafter Abraham; of record), and Ryu et al., 2014 (hereinafter Ryu), as evidenced by Kaczanowska et al., 2013 (hereinafter Kaczanowska; of record).
With regard to amended claim 1, which recites “an immunogenic composition for an mRNA vaccine, comprising an mRNA-encoded antigen and a kinetically controllable immune modulator as active ingredients,
wherein the kinetically controllable immune modulator is bound to a cleavable linker at the NH2 group which is a critical moiety of the immune modulator,
wherein the immune modulator is [a] toll-like receptor 7 or 8 agonist,
wherein the toll-like receptor 7 or 8 agonist is any one or more selected from the group consisting of imidazoquinoloine[sic]-based agonist, 8-hydroxyadenine-based agonist, pteridone-based agonist, 2-aminopyrimidine-based agonist, benzoazepine-based agonist, and 7-thia-8 oxoguanosine-based agonist, and
wherein the cleavable linker comprises any one or more bonds selected from the group consisting of disulfide, carbamate, hydrazine, ester, peptide, hydrazone, phosphodiester, thioketal bonds, and a combination thereof,” as previously set forth, Valiante discloses an RNA cancer vaccine comprising an mRNA open reading frame encoding at least one cancer antigenic polypeptide or an immunogenic fragment thereof, as well as a polypeptide that enhances the immune response, such as a constitutively active human STING polypeptide (paragraphs [0005]-[0007], [0034], and [0037]). However, Valiante is silent as to the instantly claimed toll-like receptor 7 or 8 agonist and species thereof, as well as to the claimed cleavable linker connecting the mRNA encoded antigen and the critical moiety of the immune modulator.
Regarding the claimed cleavable linker connected to a toll-like receptor 7 or 8 agonist, this deficiency is cured by Coffman, which discloses cleavable linkers that promote local release and/or local retention of a bioactive form of the TLR7/8 agonist administered therein and also stimulate an effective immune response (abstract; paragraphs [0002] and [0008]). Coffman specifically discloses that the subject matter taught therein relates to methods for preparation of a therapeutic agent or vaccine adjuvant (paragraphs [0158] and [0401]) capable of targeting specific tissues, thereby reducing unwanted systemic immune activation (paragraph [0007]). Additionally, Coffman explicitly discloses that the cleavable, self-eliminating linkers taught therein maintain the TLR7/8 agonist in a relatively inactive state prior to cleavage of said linker, after which the TLR7/8 agonist is released in its active form (paragraphs [0006] and [0364]). This disclosure of a cleavable linker blocking activity of an immune modulator when bound to said immune modulator and restoring activity of said immune modulator upon cleavage of said linker is considered to read on the instantly claimed cleavable linker bound to the active site of an immune modulator. Furthermore, Figure 4 of Coffman illustrates the kinetic control of the immune modulator (IMDQ-a TLR7/8 agonist), wherein said immune modulator is released over several hours (see also paragraph [0657]). Finally, Coffman further discloses that the cleavable linkers taught therein may be dimethyl disulfide cleavable linkers (Figure 3; paragraphs [0090], [0382], [0391], and [0395]) comprising disulfide bonds, as instantly claimed.
Regarding the claimed TLR7/8 agonist species and critical moiety thereof, this deficiency is cured by Ryu. Ryu discloses light-activated TLR7/8 agonists such as imidazoquinoline (abstract; page 10823, column 1, paragraph 2; Figure 1), which is a TLR7/8 agonist species recited at instant claim 1. Furthermore, with specific regard to the claimed NH2 critical moiety, Ryu identifies said NH2 as a critical moiety at Figure 2 and further discloses that caging said amine blocks activity, while un-caging said amine restores activity (page 10823, column 2, paragraphs 1 and 2; page 10824, column 1, paragraph 2).
Thus, it is considered that Valiante, Coffman, and Ryu collectively disclose each and every limitation of instant claim 1.
With regard to amended claim 2, which recites “the immunogenic composition of claim 1, wherein translation of [the] mRNA[-encoded antigen] into a protein proceeds after administration of the immunogenic composition, and the cleavable linker binding to the critical moiety of the toll-like receptor 7 or 8 agonist is sequentially cleaved to induce the activation function of the immune modulator,” as set forth above, Valiante discloses an RNA cancer vaccine comprising an mRNA open reading frame encoding at least one cancer antigenic polypeptide or an immunogenic fragment thereof, as well as a polypeptide that enhances the immune response, such as a constitutively active human STING polypeptide (paragraphs [0005]-[0007], [0034], and [0037]). Valiante specifically discloses that mRNA vaccines are superior to other vaccine technology, as they are better designed to produce the appropriate antigenic protein conformation upon translation by co-opting natural cellular machinery (paragraph [0006]). Thus, Valiante discloses translation of the antigenic mRNA, as in instant claim 2.
Furthermore, as set forth above, Coffman discloses kinetic control of an immune modulator such as IMDQ (a TLR7/8 agonist) by attaching said immune modulator to a cleavable linker such that the cleavable linker blocks activity of the immune modulator until the linker is cleaved, after which the immune modulator is released in its active form as a vaccine adjuvant, said release being delayed several hours after administration of the vaccine (abstract; paragraphs [0002], [0006], [0008], [0364], and [0657]; Figure 4), wherein said vaccine comprises an mRNA-encoded antigen that is translated into an antigenic protein, as disclosed in Valiante.
Finally, with regard to the claimed critical moiety, Ryu identifies NH2 as a critical moiety at Figure 2 and further discloses that caging said amine blocks activity, while un-caging said amine restores activity (page 10823, column 2, paragraphs 1 and 2; page 10824, column 1, paragraph 2).
Thus, it is considered that Valiante, Coffman, and Ryu collectively disclose each and every additional limitation of instant claim 2.
With regard to claim 5, which recites “the cleavable linker [of the immunogenic composition of claim 1] further comprises ethylene oxide or ethylene glycol at one or both ends thereof,” Coffman further discloses that the cleavable linkers taught therein may comprise ethylene oxide or ethylene glycol species at the N-terminus (paragraphs [0146] and [0671]; claims 1, 77, and 86). Thus, it is considered that Coffman discloses each and every additional limitation of instant claim 5.
With regard to amended claim 6, which recites “the cleavage of the cleavable linker [of the immunogenic composition of claim 1] is achieved by enzymatic activity, change in pH, redox potential, or temperature,” Coffman further discloses that the cleavable linkers taught therein may be cleaved by a proteolytic enzyme such as Cathepsin B (paragraph [0383]). Thus, it is considered that Coffman discloses each and every additional limitation of instant claim 6.
With regard to amended claim 7, which recites “any one or more material selected from the group consisting of cholesterol, a lipid, a protein, an amino acid, a peptide, and an oligonucleotide is/are bound to one end of the cleavable linker [of the immunogenic composition of claim 1],” Coffman further discloses that the cleavable linkers taught therein may be peptide-based cleavable linkers comprising amino acid residues and amino acid motifs (paragraph [0383]). Such peptide-based cleavable linkers must necessarily have amino acid residues bound at their ends, as instantly claimed. Thus, it is considered that Coffman discloses each and every additional limitation of instant claim 7.
With regard to amended claim 10, which recites “the mRNA-encoded antigen and the kinetically controllable immune modulator [of the immunogenic composition of claim 1] are loaded into any one or more drug delivery systems selected from the group consisting of a nanoliposome, a nanoemulsion, a nanomicelle, a hydrogel, a scaffold, a solid nanoparticle, and a polymeric nanoparticle,” while both Valiante and Coffman disclose delivery systems such as lipid nanoparticles (Valiante, paragraph [0201]), they do not explicitly disclose the specific species of the instantly claimed drug delivery systems. However, Abraham cures this deficiency by disclosing that nanoliposomes facilitate safe and efficient therapeutic mRNA delivery, such as mRNA vaccines (abstract). Thus, it is considered that Abraham discloses each and every additional limitation of instant claim 10.
With regard to amended claim 11, which recites “the mRNA-encoded antigen [of the method of claim 10] is cytosolically delivered, after which the kinetically controllable immune modulator interacts with a receptor on a cell surface, or in an endosome or lysosome,” as set forth above, Valiante specifically discloses that mRNA vaccines are superior to other vaccine technology, as they are better designed to produce the appropriate antigenic protein conformation upon translation by co-opting natural cellular machinery (paragraph [0006]) within the cytoplasm (or cytosol) of cells (Abraham: page 162, column 1, paragraph 1). Furthermore, Coffman further discloses that the TLR7/8 agonist taught therein interacts with toll-like receptors that are transmembrane proteins (paragraphs [0003] and [0005]). While Coffman does not specifically disclose that the TLR7/8 agonist taught therein interacts with cell surface, endosomal, or lysosomal receptors, it is known in the art that TLR7/8 localizes to endosomal membranes (Kaczanowska: Table 1). Thus, it is considered that Valiante and Coffman, as evidenced by Kaczanowska, collectively disclose each and every additional limitation of instant claim 11.
With regard to claim 13, which recites “the composition for an mRNA vaccine [of claim 1] is used for prevention or treatment of any one or more diseases selected from the group consisting of an infectious disease, cancer, metabolic syndrome, an autoimmune disease, and a rare disease,” Valiante discloses that the mRNA vaccines taught therein are suitable for treating cancer (abstract; paragraph [0006]). Coffman also discloses that the vaccines comprising cleavable linkers attached to TLR agonists taught therein are suitable for treating cancer (paragraph [0002]).
Given that Valiante discloses an mRNA vaccine comprising at least one mRNA antigen and an immune modulator; that Coffman discloses cleavable linkers relevant to vaccine preparation that facilitate tissue-specific targeting and release of said immune modulator over several hours following administration; that Ryu discloses controlled activation of TLR7/8 agonists (i.e. imidazoquinoline) by caging and uncaging the critical NH2 moiety; and that Abraham discloses that nanoliposomes facilitate safe and efficient therapeutic mRNA delivery (i.e. mRNA vaccines), it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to connect the mRNA antigen and immune modulator disclosed in Valiante with the cleavable linker attached to a critical residue of an immune modulator (i.e. the NH2 of a TLR7/8 agonist such as imidazoquinoline as disclosed in Ryu) disclosed in Coffman and delivered via nanoliposomes as disclosed in Abraham to predictably produce a vaccine that facilitates tissue-specific targeting and reduces systemic immune activation by controlling the release of the immune modulator, thereby treating diseases such as cancer. One would have been motivated to make such a modification in order to receive the expected benefit of reducing unwanted systemic immune activation, thereby treating diseases such as cancer.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6, 7, 10, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-12, 17, and 18 of copending Application No. 17/391,224 (corresponds to US 2022/0008411 A1; of record). Although the claims at issue are not identical, they are not patentably distinct from each other, as set forth below.
Copending claim 10 recites “a vaccine composition comprising the adjuvant composition of [copending] claim 9 and an antigen,” wherein copending claim 9 recites “an adjuvant composition comprising the toll-like receptor 7/8 agonist-cholesterol complex of [copending] claim 1.” Copending claim 11 further recites that the antigen of the vaccine composition of copending claim 10 is selected from a group of antigen species, including a polynucleotide, which reads on the instantly claimed “mRNA-encoded antigen” of instant claim 1. Furthermore, copending claim 1 recites “a toll-like receptor 7/8 agonist, wherein the linkage is made in separable form, and wherein the separable linkage is made by at least one selected from the group consisting of a carbamate, a disulfide, and ester, a peptide, an azide, and a combination thereof” and “wherein the toll-like receptor 7/8 agonist is selected from the group consisting of an imidazoquinoline-based agonist….”. Finally, copending claim 18 recites that the complex of copending claim 1 “chemically bond[s] a cholesterol to an amine group of an active site of the toll-like receptor 7/8 agonist using a linker which is made in separable form. Thus, copending claims 1, 9-11, and 18 collectively recite a vaccine composition comprising an adjuvant composition, which is itself comprised of a toll-like receptor 7/8 agonist such as imidazoquinoline in which cholesterol is linked to an active site (i.e. an amine) of a toll-like receptor 7/8 agonist, as well as a polynucleotide-based antigen.
The separable linkage of the copending application is recited to be cleaved “in response to a tumor microenvironment, a temperature, an endosomal enzyme, a lysosomal enzyme, or pH in cells” such that “a kinetic function of the toll-like receptor 7/8 agonist [is recovered] within 4 days” at copending claim 6. Furthermore, the composition of the copending application is recited to be packaged into a nanoparticle composition (copending claim 7), “wherein the nanoparticle comprises at least one selected from the group consisting of a nanoliposome, a nanoemulsion, a nanomicelle, a solid nanoparticle, and a polymer nanoparticle” (copending claim 8).
Finally, the composition of the copending application is recited to be useful “for controlling an immune function or preventing or treating a cancer” at copending claim 12, as well as for inhibiting cancer proliferation at copending claim 17 (which reads on treatment of cancer under broadest reasonable interpretation).
In comparison, instant claim 1 recites “an immunogenic composition for an mRNA vaccine,” said composition comprising an antigen encoded by mRNA and a kinetically controllable immune modulator such as imidazoquinoline in a complex bound to a cleavable linker, said cleavable linker being bound to a critical NH2 group of imidazoquinoline (or another toll-like receptor 7 or 8 agonist), wherein the “cleavable linker comprises any one or more bonds selected from the group consisting of disulfide, carbamate, hydrazine, ester, peptide, hydrazone, phosphodiester, thioketal bonds, and a combination thereof.” Instant claim 7 further recites that the toll-like receptor 7/8 agonist comprises cholesterol bound to an end of said cleavable linker. The cleavable linker of the instant application is recited to be cleaved “achieved by enzymatic activity, change in pH, redox potential, or temperature” at instant claim 6. The instantly claimed immunogenic composition is “loaded into any one or more drug delivery systems selected from the group consisting of a nanoliposome, a nanoemulsion, a nanomicelle, a hydrogel, a scaffold, a solid nanoparticle, and a polymeric nanoparticle” as recited at instant claim 10. Finally, the instantly claimed immunogenic composition is recited to be “used for prevention or treatment of any one or more diseases selected from the group consisting of an infectious disease, cancer, metabolic syndrome, an autoimmune disease, and a rare disease” at instant claim 13.
Thus, while the instant and copending applications do not recite identical limitations, the subject matter claimed therein is not patentably distinct, as both applications recite an immunogenic composition for a vaccine, said immunogenic composition comprising a polynucleotide-based antigen and a toll-like receptor 7/8 agonist (i.e. imidazoquinoline) attached via a cleavable linker at the critical amine group thereof for the treatment of diseases such as cancer. It is considered that both the copending and instant compositions are subject to kinetic control, as the toll-like receptor 7/8 agonist is recited to recover “a kinetic function…within 4 days” following cleavage of the separable linker (copending claim 6).
Furthermore, while the Examiner considers that the restoration of kinetic function of the toll-like receptor 7/8 agonist within 4 days reads on the kinetic control of the instant application, even if one does not accept this rationale, per MPEP § 2114 and § 2173.05(g), when claimed subject matter is structurally identical to that of the art, as set forth above, the instantly claimed subject matter and that of the prior art must have identical functions. Therefore, the kinetic control of the instant application is considered to be a necessary and expected outcome of the structure of the compositions of both the instant and copending applications.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 6, 7, 10, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6, 8, 10-12, and 14-15 of copending Application No. 17/909,066 (reference application; corresponds to US 2023/0100429 A11) in view of Ryu et al., 2014 (hereinafter Ryu).
Copending claim 11 recites “a vaccine composition comprising the adjuvant composition of [copending] claim 10 and an antigen as active ingredients,” wherein copending claim 10 recites “an adjuvant composition comprising the nano-molecule of claim 1 as an active ingredient.” The nano-molecule of claim 1 is recited to comprise a toll-like receptor 7 or 8 agonist such as imidazoquinoline, wherein the toll-like receptor 7 or 8 agonist is in an inactive state by binding a lipid to an activation site, wherein the binding between the toll-like receptor agonist and the lipid is cleavable (copending claim 1). Copending claim 12 further recites that the antigen of the vaccine composition of copending claim 10 is selected from a group of antigen species, including a polynucleotide, which reads on the instantly claimed “mRNA-encoded antigen” (instant claim 1). The cleavable bond recited at copending claim 1 is further recited to be “selected from the group consisting of a carbamate bond, a disulfide bond, an ester bond, a peptide bond, an azide bond, an amide bond, a hydrazone bond, a thioether bond, a phosphodiester bond, a thioketal bond, and any combination thereof” at copending claim 4. Thus, copending claims 1, 4, and 10-12 collectively recite a vaccine composition comprising an adjuvant composition, which is itself comprised of a toll-like receptor 7/8 agonist such as imidazoquinoline, as well as a polynucleotide-based antigen.
This linkage is explicitly recited as being made in a separable form, wherein the separable linkage is made by at least one specified chemical bond, such as a disulfide, carbamate, ester, peptide, azide, or combination thereof (copending claim 4). Cleavage of this separable linkage is recited to occur “in response to a tumor microenvironment, or enzymes and pH of endosomes and lysosomes in cells” such that “a kinetic function is recovered within 4 days” (copending claim 6).
The composition of the copending application is further recited to comprise a nano-molecule at copending claim 1, wherein the nano-molecule “is any one or more selected from the group consisting of a nanoliposome, a nanoemulsion, a nanomicelle, and a polymer nanoparticle” (copending claim 8).
Finally, the composition of the copending application is recited to be useful “for preventing or treating cancer” at copending claim 14, as well as for inhibiting cancer proliferation at copending claim 15 (which reads on treatment of cancer under broadest reasonable interpretation).
In comparison, instant claim 1 recites “an immunogenic composition for an mRNA vaccine,” said composition comprising an antigen encoded by mRNA and a kinetically controllable immune modulator such as imidazoquinoline in a complex bound to a cleavable linker, said cleavable linker being bound to a critical NH2 group of imidazoquinoline (or another toll-like receptor 7 or 8 agonist), wherein the “cleavable linker comprises any one or more bonds selected from the group consisting of disulfide, carbamate, hydrazine, ester, peptide, hydrazone, phosphodiester, thioketal bonds, and a combination thereof.” Instant claim 7 further recites that the toll-like receptor 7/8 agonist comprises cholesterol bound to an end of said cleavable linker. The cleavable linker of the instant application is recited to be cleaved “achieved by enzymatic activity, change in pH, redox potential, or temperature” at instant claim 6. The instantly claimed immunogenic composition is “loaded into any one or more drug delivery systems selected from the group consisting of a nanoliposome, a nanoemulsion, a nanomicelle, a hydrogel, a scaffold, a solid nanoparticle, and a polymeric nanoparticle” as recited at instant claim 10. Finally, the instantly claimed immunogenic composition is recited to be “used for prevention or treatment of any one or more diseases selected from the group consisting of an infectious disease, cancer, metabolic syndrome, an autoimmune disease, and a rare disease” at instant claim 13.
Thus, while the instant and copending applications do not recite identical limitations, the subject matter claimed in the copending application reads on that of the instant application, with the exception of the attachment of the cleavable linker to a critical NH2 group of a toll-like receptor 7 or 8 agonist such as imidazoquinoline. However, this deficiency is cured by Ryu. As set forth above, Ryu discloses light-activated TLR7/8 agonists such as imidazoquinoline (abstract; page 10823, column 1, paragraph 2; Figure 1), which is a TLR7/8 agonist species recited at instant claim 1. Furthermore, with specific regard to the claimed NH2 critical moiety, Ryu identifies said NH2 as a critical moiety at Figure 2 and further discloses that caging said amine blocks activity, while un-caging said amine restores activity (page 10823, column 2, paragraphs 1 and 2; page 10824, column 1, paragraph 2).
Therefore, given that the copending application recites the instantly claimed subject matter, with the exception of the attachment of the cleavable linker claimed therein to a critical NH2 group of a toll-like receptor 7 or 8 agonist such as imidazoquinoline, and that Ryu discloses controlled activation of TLR7/8 agonists (i.e. imidazoquinoline) by caging and uncaging the critical NH2 moiety, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to attach the cleavable linker recited in the copending application to the critical NH2 moiety responsible for governing imidazoquinoline function per Ryu to predictably control the activity of imidazoquinoline in the vaccine composition claimed therein. One would have been motivated to make such a modification in order to receive the expected benefit of generating a vaccine capable of controlling the activity of imidazoquinoline as an adjuvant in said vaccine.
Furthermore, while the Examiner considers that the restoration of kinetic function of the toll-like receptor 7/8 agonist within 4 days reads on the kinetic control of the instant application, even if one does not accept this rationale, per MPEP § 2114 and § 2173.05(g), when claimed subject matter is structurally identical to that of the art, as set forth above, the instantly claimed subject matter and that of the prior art must have identical functions. Therefore, the kinetic control of the instant application is considered to be a necessary and expected outcome of the structure of the compositions of both the instant and copending applications.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 5-7, 10, 11, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, and 14-17 of copending Application No. 18/040,328 (reference application; corresponds to US 2023/0355750 A1) in view of US 2019/0351040 A1 (hereinafter Valiante; of record), Abraham et al., 2017 (hereinafter Abraham; of record), and Ryu et al., 2014 (hereinafter Ryu).
Copending claim 14 is drawn to a kinetically acting adjuvant ensemble composition comprising a first and second adjuvant, wherein the second adjuvant “is a complex in which a cleavable linker binds to its active site” (copending claim 1), said composition being used for “prevention or treatment of any one or more diseases selected from the group consisting of an infectious disease, cancer, metabolic syndrome, an autoimmune disease, and a rare disease” (copending claim 14), as well as for inhibiting “cancer growth, metastasis, recurrence, or resistance to anticancer therapy” (copending claim 17), which reads on treatment of cancer under broadest reasonable interpretation. The claimed adjuvant ensemble composition “further comprises an antigen” (copending claim 15), wherein the antigen is “one or more selected from the group consisting of a protein, a recombinant protein, a glycoprotein, a gene, a peptide, a polysaccharide, a lipopolysaccharide, a polynucleotide, a cell, a cell lysate, a bacterium, and a virus” (copending claim 16). As set forth above, the recitation of an antigenic polynucleotide reads on the instantly claimed “mRNA-encoded antigen” of instant claim 1. Additionally, while the copending application does not explicitly recite that the composition claimed therein is a vaccine composition, under broadest reasonable interpretation a composition for preventing diseases reads on a vaccine composition (as disclosed at page 1, lines 11-12), as instantly claimed.
Regarding the cleavable linker of the copending application set forth above, the cleavable linker is recited to comprise “any one or more bonds selected from the group consisting of disulfide, carbamate, hydrazine, ester, peptide, azide, amide, hydrazone, thioether, phosphodiester, thioketal, and a combination thereof” at copending claim 3. Furthermore, the cleavable linker of the copending application “is bound to the active site of the second adjuvant to maintain an inactive state, and then the cleavable linker blocking the active site is cleaved within 2 to 12 hours,” thereby temporally delaying the activity of the immune activating material (copending claim 2). The cleavable linker of the copending application “further comprises ethylene oxide or ethylene glycol at one or both ends thereof” (copending claim 4) and “is cleaved at the chemical bond of a binding site due to any one or more factors selected from the group consisting of an enzyme, pH, redox potential, a temperature, ultrasonic wave, magnetic force, and a light source” (copending claim 5), and is bound to “cholesterol, a lipid, a protein, an amino acid, a peptide [or] and oligonucleotide” at an end (copending claim 6).
The adjuvant ensemble composition of the copending application is further recited to be “loaded in any one or more drug delivery systems selected from the group consisting of a nanoliposome, a nanoemulsion, a nanomicelle, a hydrogen, a scaffold, a solid nanoparticle and a polymeric nanoparticle” at copending claims 7 and 8. Additionally, the adjuvant ensemble composition and drug delivery system of the copending application “further comprises a ligand that is able to react with a receptor present on the surface of immune cells or in an endosome or cytosol” (copending claim 9) or “any one or more immune activating material selected from the group consisting of a toll-like receptor agonist, saponin, an antiviral peptide, an inflammasome inducer, a NOD ligand, a cytosolic DNA sensor (CDS ligand), a stimulator of interferon gene (STING) ligand, an outer wall component of a pathogen, alum, a lipid, a combination thereof, and a derivative thereof” (copending claims 10-12).
In comparison, instant claim 1 recites “an immunogenic composition for an mRNA vaccine, comprising an mRNA-encoded antigen and a kinetically controllable immune modulator as active ingredients,
wherein the kinetically controllable immune modulator is bound to a cleavable linker at the NH2 group which is a critical moiety of the immune modulator,
wherein the immune modulator is [a] toll-like receptor 7 or 8 agonist,
wherein the toll-like receptor 7 or 8 agonist is any one or more selected from the group consisting of imidazoquinoloine[sic]-based agonist, 8-hydroxyadenine-based agonist, pteridone-based agonist, 2-aminopyrimidine-based agonist, benzoazepine-based agonist, and 7-thia-8 oxoguanosine-based agonist, and
wherein the cleavable linker comprises any one or more bonds selected from the group consisting of disulfide, carbamate, hydrazine, ester, peptide, hydrazone, phosphodiester, thioketal bonds, and a combination thereof” and wherein said cleavable linker further comprises “ethylene oxide or ethylene glycol at one or both ends thereof” (instant claim 5). Said immunogenic composition is further recited to comprise cholesterol a lipid, a protein, an amino acid, a peptide, or an oligonucleotide bound to an end of said cleavable linker (as recited at instant claim 7). The cleavable linker of the instant application is recited to be cleaved “achieved by enzymatic acthivity, change in pH, redox potential, or temperature” at instant claim 6. The instantly claimed immunogenic composition is “loaded into any one or more drug delivery systems selected from the group consisting of a nanoliposome, a nanoemulsion, a nanomicelle, a hydrogel, a scaffold, a solid nanoparticle, and a polymeric nanoparticle” as recited at instant claim 10. Furthermore, the claimed delivery system is recited to deliver the mRNA-encoded antigen to the cytosol, after which the kinetically controllable immune modulator interacts with a receptor on a cell surface, or in an endosome or lysosome” (instant claim 11). Finally, the instantly claimed immunogenic composition is recited to be “used for prevention or treatment of any one or more diseases selected from the group consisting of an infectious disease, cancer, metabolic syndrome, an autoimmune disease, and a rare disease” at instant claim 13.
The claims of the copending application set forth above read on the claims of the instant application set forth above, with the exception of the limitations regarding delivery of the mRNA antigen to the cytosol and attachment of the cleavable linker to a critical NH2 group of a toll-like receptor 7 or 8 agonist such as imidazoquinoline. However, this deficiency is cured by Valiante, Abraham, and Ryu. As set forth above, Valiante discloses an RNA cancer vaccine comprising an mRNA open reading frame encoding at least one cancer antigenic polypeptide or an immunogenic fragment thereof, said antigenic polypeptide or immunogenic fragment thereof being translated by co-opting natural cellular machinery, as well as a polypeptide that enhances the immune response, such as a constitutively active human STING polypeptide (paragraphs [0005]-[0007], [0034], and [0037]). Valiante specifically discloses that mRNA vaccines are superior to other vaccine technology, as they are better designed to produce the appropriate antigenic protein conformation upon translation by co-opting natural cellular machinery (paragraph [0006]) within the cytoplasm (or cytosol) of cells (Abraham: page 162, column 1, paragraph 1). Furthermore, as set forth above, Ryu discloses light-activated TLR7/8 agonists (as in the copending application-see copending claim 10 as set forth above) such as imidazoquinoline (abstract; page 10823, column 1, paragraph 2; Figure 1), which is a TLR7/8 agonist species recited at instant claim 1. Furthermore, with specific regard to the claimed NH2 critical moiety, Ryu identifies said NH2 as a critical moiety at Figure 2 and further discloses that caging said amine blocks activity, while un-caging said amine restores activity (page 10823, column 2, paragraphs 1 and 2; page 10824, column 1, paragraph 2).
Therefore, given that the copending application recites the instantly claimed subject matter, with the exception of the attachment of the cleavable linker claimed therein to a critical NH2 group of a toll-like receptor 7 or 8 agonist such as imidazoquinoline and delivery of the immunogenic composition to the cytosol; that Ryu discloses controlled activation of TLR7/8 agonists (i.e. imidazoquinoline) by caging and uncaging the critical NH2 moiety; and that Valiante and Abraham collectively disclose that mRNA-based vaccines are superior to other vaccine technology due to co-opting natural cellular machinery within the cytoplasm, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to attach the cleavable linker recited in the copending application to the critical NH2 moiety responsible for governing imidazoquinoline function per Ryu to predictably control the activity of imidazoquinoline in the vaccine composition claimed therein within the cytosol (as disclosed in Valiante and Abraham). One would have been motivated to make such a modification in order to receive the expected benefit of generating a vaccine capable of controlling the activity of imidazoquinoline as an adjuvant in said vaccine within the cytosol of a targeted cell.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Claims 1 and 2 are objected to.
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 Sarah E Allen whose telephone number is (571)272-0408. The examiner can normally be reached M-F 8-5.
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/SARAH E ALLEN/ Examiner, Art Unit 1637
/J. E. ANGELL/ Primary Examiner, Art Unit 1637
1 The Examiner notes that the US PGPub associated with Application No. 17/909,066 was erroneously referenced as US 2023/0346924 A1. This was the incorrect publication identifier. US 2023/0100429 A1 (referenced herein) is the correct publication identifier.
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