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 .
This office action is in response to the paper filed on 1/26/2026. Claims 1-14 were previously presented. No new claims are presented. Applicant elects the invention of Group I (Claims 1-8) and the species of SEQ ID NO: 1, without traverse.
Election/Restriction
Applicant’s election of inventions of Group I (Claims 1-8), in the reply filed on 1/26/2026, is acknowledged.
Claims 9-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/26/2026.
Applicant is reminded that upon the cancelation of claim to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Application Status
The action is written in response to applicant’s correspondence received 1/26/2026. Claims 1-8 are currently pending in the instant application.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 7/18/2022. It is noted, however, that applicant has not filed a certified copy of the CN202210839969.2 application as required by 37 CFR 1.55.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. In the case of the instant application, replacement drawings filed on 10/26/2023 contain color in Figures 5 and 32A-32B.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The disclosure is objected to because of the following informalities: The drawings for Fig. 32 disclose Fig. 32A and 32B. In the case where the drawings show Fig. 32A and 32B and the brief description of the drawings refer to only Fig. 32, the brief description is objected to, and applicant is required to provide a brief description of Fig. 32A and 32B. See MPEP 608.01(f).
Appropriate correction is required.
Claim Objections
Claim 3 is objected to because of the following informalities: Claim recites “an uncapped mRNA according to claim 1 and an LNP”. Here, the appropriate wording would be “the LNP” instead of “an LNP”.
Claim 8 is objected to because of the following informalities: Claim recites “comprising an mRNA-LNP according to claim 3”. This claim is improper as previously introduced subject matter should be recited as “the mRNA-LNP” for antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 112a
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 are 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.
Claim language of claims 1-8 currently read as the region B comprising of one or more of the following genes, meaning single genes as well as a combination of genes within the mRNA, including a combination of a gene encoding a truncated D-type envelope from HSV2 and a mutated gene encoding Delta strain SARS-CoV-2 spike protein. Applicant does not disclose in the specification where such combinations are present. This is exemplified in Table 3 of the specification of the instant application, where applicant discloses six uncapped mRNAs, including gDED-mRNA, gDFR-mRNA, S protein mRNA from the delta strain, delta strain S protein with UTP replaced, and two variations of the Fluc-mRNA. However, there is no combinations of multiple genes present. Therefore, applicant, at the time of filing, does not have possession of an uncapped mRNA where region B comprises of multiple genes.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5, 6, and 7 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.
Claims 5, 6, and 7 all recite the mRNA-LNP, where the LNP is prepared with “the assistance of a helper molecule”. Here, the term “the assistance” is unclear as whether helper molecules are used in the formulation of the mRNA-LNP or if the helper molecules only play a role in mRNA-LNP formation as is not involved in the final composition. The specification of the instant application does disclose that the cationic lipid compound and a helper molecule is dissolved in ethanol at a set molar ratio to obtain an ethanol phase, where the uncapped mRNA of the first aspect is dissolved in sodium acetate buffer with the ethanol phase at a volume ratio to form the mRNA-LNP mixture. The mRNA-LNP mixture is then concentrated and filter sterilized to obtain the mRNA-LNP. However, even in this context, the language of “assistance” implies a function of the helper molecule that is unclear and said function is unclear based on the claim language and the specification.
Claim 6 recites the limitation "The mRNA-LNP according to claim 3, wherein the helper molecule is" in claim 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 is rejected as being indefinite as the molar ratio of the LNP to the helper molecule is unclear. The claim reads as reciting the molar ratio of the LNP to the helper molecule, which should be a ratio comprising of two elements (comparing the ratio of the LNP and the helper molecule). However, the claim presents 4 ratio elements. To overcome this rejection, applicant should remove “the LNP to the helper molecule”, therefore making it clear that the molar ratio refers to the LNP composition.
Claim Rejections – Improper Markush
Claims 1 and 2 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of region B is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: Applicant claims a gene of region B from a glycoprotein ectodomain from herpes simplex virus 2 (HSV2) set forth in SEQ ID NO: 1 and SEQ ID NO: 2, as well as a mutated gene encoding Delta strain SARS-CoV2 spike protein set forth in SEQ ID NO: 3. HSV2 glycoprotein ectodomain and CoV2 spike protein do not share structural similarities as being related to completely different viruses. Though applicant elected SEQ ID NO: 1, claims are examined on the full merit of the claim, regardless of elected species.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
Claim(s) 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Lemoine (US 2021/0214729, 7/15/2021) in view of Yang et al. (US9566325B2, 2/14/2017), in further view of Mauro et al. (A critical analysis of codon optimization in human therapeutics, Cell Press, Volume 20, Issue 11, Pgs. 604-613, 2014).
Regarding claim 1, Lemoine teaches a stable, uncapped linear mRNA molecule which can be translated with high efficiency (see paragraph 0012 and 0013). Lemoine further teaches that the first aspect of the invention referring to a mRNA molecule lacking a cap molecule comprises of a 5’-UTR region comprising of a consensus sequence, and at least one copy of an internal ribosome entry site (IRES) RNA sequence (see paragraph 0019). In addition, Lemoine discloses that in another embodiment of the invention, a 3’-UTR region comprises of a poly(A) sequence is included, where the preferred embodiment includes a polyadenylated tail (see paragraph 0114-0116). Lemoine further teaches the term “mRNA molecule” means any linear chain of ribonucleotides (see paragraph 0013).
Regarding claim 2, Lemoine teaches where according to another aspect, the invention relates to a host cell comprising said vector. The term “host cell” is intended to refer to a cell in which recombinant expression vector has been introduced in order to express the mRNA of the invention (see paragraph 0142). In this case, it is widely known that a vector is a broad term that refers to any DNA molecule used to deliver foreign genetic material into a host cell, including a plasmid. Furthermore, Lemoine discloses that preferably, the vector of the invention is a plasmid (see paragraph 0140).
Lemoine teaches there the protein of interest coded by the mRNA may also be an antigen, capable of generating an immune response in humans or animals, for the realization of vaccines. They may in particular be antigenic proteins specific for the Epstein Barr virus, the HIV virus, and the hepatitis B virus (see paragraph 0099).
Lemoine teaches that the use of stable uncapped, linear mRNA molecules are particularly advantageous as its production cost is much lower than that of a conventional mRNA comprising a cap molecule or an analog thereof (see paragraph 0012).
Lemoine does not teach where a coding region for translation as to generate a protein, wherein the coding region comprises of a truncated D-type envelope glycoprotein ectodomain coding gene from herpes simplex virus 2 (HSV2), as set forth in SEQ ID NO: 1.
Yang teaches therapeutic vaccines for treating herpes simplex virus-type 2 infections where the antigen is an HSV-2 antigen, which can include gD glycoproteins or derivatives thereof. Furthermore, Yang teaches that truncated variants of gD glycoproteins can be used where the truncated extracellular domain of gD (amino acids 1-314) are presented as SEQ ID NO: 2. SEQ ID NO: 2 of Yang and the protein translated nucleotide sequence of SEQ ID NO: 1 of the instant application share a 94% similarity with 100% similarity between amino acids 1-305. The instant application SEQ ID NO: 1 encodes for 306 nucleotides with the last amino acid being a stop codon. Yang does not teach a 100% identity to the nucleotide sequence SEQ ID NO: 1 of the instant application.
Mauro teaches that codon optimization can be used for increased protein expression, wherein the attempt to produce more protein by altering codon assignments has led to the broad use of codon-optimized mRNAs for the bioproduction of protein pharmaceuticals and nucleic acid therapies (see pg. 605).
Mauro further teaches this prospect of codon optimization has led to the development of numerous codon-optimization programs and commercial services (see pg. 605) including genetic vaccines (see Pg. 611).
It would have been obvious to one with ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized the uncapped, linear mRNA presented in Lemoine, to manufacture a stable mRNA with reduced manufacturing costs, as Lemoine states “this (uncapped, linear) mRNA is particularly advantageous as its production cost is much lower than that of a conventional mRNA comprising a cap molecule” (see paragraph 0012), and combine it with the truncated glycoprotein ectodomain coding gene (gD) from HSV2 of the instant application encoded by SEQ ID NO:1. Though SEQ ID NO: 1 does not have a clear nucleotide sequence match to prior art as it is codon optimized for the instant application, the translated amino acid sequence has 94% identity to a truncated HSV2 glycoprotein D presented in Yang, with the first 305 amino acids sharing 100% similarity. The nucleotide sequence encoding the truncated extracellular domain gD of HSV2 was known in the art, and making a vaccine against HSV2 was an art-recognized goal as taught by Yang before the effective filing date.
Furthermore, Mauro teaches that one would codon optimize in order to achieve higher levels of protein expression, including for making nucleic acid vaccines using “codon-optimized programs and commercial services” which at the time of the invention, would have also been well known in the art.
SEQ ID NO:1, although truncated, does encode for a wild type human HSV2 glycoprotein D that was well-known in the art at the filing date of the invention. Since the wild type HSV2 gD comprises of a finite number of amino acids, one would use the rationale of codon optimization present in Mauro, to optimize the wild type nucleic acid sequence of human HSV2 gD to eventually reach the codon optimized nucleic acid sequence presented in SEQ ID NO: 1 of the instant application, with a reasonable expectation of success.
In view of the foregoing, claims 1 and 2 would have been prima facie obvious before the effective filing date.
Claim(s) 3, 4, 5, 6, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Lemoine (US 2021/0214729A1, 7/15/2021), Yang (US9566325B2, 2/14/2017), and Mauro (A critical analysis of codon optimization in human therapeutics, Cell Press, Volume 20, Issue 11, Pgs. 604-613, 2014) as applied to claims 1 and 2 above, and further in view and Cui et al. (CN114163345A with an effective filing date of 03/11/2022) and Drummond (WO 2022/115645 A1, priority date of 11/25/2020).
Regarding these claims, the use of uncapped mRNA of claims 1 and 2 in genetic vaccines, wherein the mRNA can be a viral antigen, are described above in Lemoine. Furthermore, Yang and Mauro teach how codon optimization would allow for the use of an uncapped mRNA encoding SEQ ID NO:1 can be used to express a truncated glycoprotein D from HSV2.
All these prior arts are silent on the formation of a lipid nanoparticle comprising an uncapped mRNA.
Regarding claim 3, Drummond discloses that lipid nanoparticles are used for the delivery of therapeutic nucleic acids to cells. Examples can include LNP pharmaceutical compositions employed in vaccines to deliver mRNA therapeutics and lipid nanoparticles typically include an ionizable cationic lipid (ICL) (See page 1, line 25).
Regarding claim 4, Cui teaches a cationic lipid (named compound 1) that has a 100% identity to formula 1 presented in claim 4 (see section with example 1).
Regarding claim 5, Cui discloses the formation of auxiliary lipid molecules in tangent with the lipid nanoparticle wherein the auxiliary lipid molecules include cholesterol and distearoylphosphatidylcholine (DSPC) (see contents of invention section, paragraph n0129 of English translation).
Regarding claim 6 and 7, Cui teaches a composition where compounds 1, 2, and 3 are dissolved and mixed with DSPC, cholesterol, and 1,2-dimyristol-rac-glycero-3-methoxypolyethylene glycol-2000 (DMG-PEG2000) at a molar ratio of 50: 10: 38.5: 1.5 (see section titled embodiment 4, paragraph n0129 of English translation). Though the instant application claims a molar ratio of 50: 10: 38: 2, this molar ratio of LNP and auxiliary lipid molecules are well known in the art. It would have been obvious to adjust 38.5 to 38 and 1.5 to 2.
Regarding claim 8, previous art of Lemoine, Yang, Mauro, and Drummond teach the prior art of an uncapped mRNA being used as a vaccine for an antigen response with viruses. Furthermore, Lemoine teaches where preferably, said composition will be supplemented with an excipient and/or a pharmaceutically acceptable vehicle (see paragraph 0161).
It would have been obvious to combine the uncapped mRNA with the lipid nanoparticle of formula 1, presented in Cui, to create a vaccine in a pharmaceutically acceptable excipient, for the purpose of expressing the glycoprotein ectodomain of HSV2 in generating an immune response. Drummond discloses that mRNA-LNPs may promote efficient uptake of the mRNA by immune cells, including tissue macrophages and dendritic cells.
Drummond discloses the LNP has the function of providing efficient delivery of an mRNA coding for antigen specific for infectious viruses, and subsequent presentation of that antigen to elicit the desired immune response to protect against corresponding infections (see pg. 30, line 15).
One with ordinary skill in the art would have been motivated to combine an uncapped linear mRNA structure disclosed in Lemoine with a region encoding for a codon optimized gD protein from HSV2, described in Yang and Mauro, with the cationic lipid disclosed in formula 1 of Cui for the formation of a LNP, with a reasonable expectation of success. One with ordinary skill in the art would have been further motivated to include this mRNA-LNP composition will further comprise a pharmaceutically acceptable excipient and formulate the mRNA-LNP composition as a vaccine or medicament as described in Lemoine.
One would be motivated to do so in order to efficiently deliver the mRNA encoding the antigen for HSV2 to an immune cell with a LNP, to avoid mRNA degradation, in order to express the antigen for HSV2, to generate an immune response. This is because an LNP was known to have the function of providing efficient delivery of an mRNA coding for a gene eliciting an antigen specific response for infectious viruses as taught by Drummond (see pg. 30, line 15). This makes an mRNA-LNP composition an art-recognized goal and was deemed technically feasible as evidence by Drummond.
In view of the foregoing, claims 3, 4, 5, 6, 7, and 8 would have been prima facie obvious before the effective filing date.
Claim(s) 3, 4, 5, 6, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Lemoine (US 2021/0214729A1, 7/15/2021), Yang (US9566325B2, 2/14/2017), and Mauro (A critical analysis of codon optimization in human therapeutics, Cell Press, Volume 20, Issue 11, Pgs. 604-613, 2014) as applied to claims 1 and 2 above, and further in view of Drummond et al. (WO 2022/115645 A1, priority date of 11/25/2020).
Lemoine teaches the use of uncapped mRNA and a viral antigen for generating an immune response as described above in claims 1 and 2.
Lemoine does not teach a mRNA-lipid nanoparticle comprising an uncapped mRNA and an LNP.
Regarding claim 3 and 4, Drummond teaches ionizable cationic lipids for lipid nanoparticles. Drummond discloses that lipid nanoparticles are used for the delivery of therapeutic nucleic acids to cells. Examples can include LNP pharmaceutical compositions employed in vaccines to deliver mRNA therapeutics and lipid nanoparticles typically include an ionizable cationic lipid (ICL) (See page 1, line 25). However, ICL compounds are undesirably sensitive to oxidation during storage.
Drummond discloses a cationic lipid that is engineered with improved stability to oxidative degradation while in storage, while retaining high transfection activity or potency in cells (see pg. 2, line 15). Drummond further teaches that in one aspect, the nucleic acid LNP composition comprises a nucleic acid, an ionizable cationic lipid selected from KC2OA, KC2, KC2-01, ALC-0315, and SM102 (see page 23, line 11). SM102 is synonymous with 8-[(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino]-octanoic acid, as claimed in claim 4 of the instant application.
Regarding claim 5, Drummond teaches the LNP composition further comprises cholesterol and a second phospholipid select from a group consisting of: DSPC, DPPC, and DOPC. This reads on the helper molecules or auxiliary lipids included in the LNP formulation.
Regarding claims 6 and 7, Drummond teaches, in some embodiments, the lipidic nanoparticle comprises ICL (a cationic lipid such as SM102), DSPC, cholesterol, and polymer-conjugated lipid in a about 49.5: 10.3: 39.5: 2.5 molar ratio (see pg. 64, line 19). Furthermore, in some embodiments, the polymer-conjugated lipid is PEG(2000)-dimyristoylglycerol (see pg. 64, line 21). Though claim 7 specifically recites a molar ratio of 50: 10: 38: 2, this molar ratio is well known in the art and Drummond recites an approximation that is identical to what is claimed in the instant application.
Regarding claim 8, Drummond discloses where in some embodiments, the composition further comprises a pharmaceutical excipient (see pg. 93, line 11). Furthermore, claim 27 of Drummond recites a method of preventing a bacterial or viral infection, the method comprising administering to a subject in need thereof an effective amount of composition, and a pharmaceutical excipient, wherein administration elicits an immune response (see claim 27).
It would have been obvious to one with ordinary skill in the art, before the effective filing date, to combine the uncapped, linear mRNA of claims 1-2 rendered obvious above, with the lipid nanoparticle composition presented by Drummond, for generating a vaccine or medicament with a reasonable expectation of success. The process of creating a stable, uncapped linear mRNA will help with production costs (see Lemoine, paragraph 0012). The LNPs, presented by Drummond, was known to promote efficient uptake by target immune cells, including tissue macrophages and dendritic cells. The efficient delivery of nucleic acids coding for antigen specific for infectious viruses or bacteria, and subsequent presentation of that antigen to elicit the desired immune response to protect against corresponding infections is a result (see pg. 30, line 15).
One with ordinary skill in the art could combine an uncapped linear mRNA structure disclosed in Lemoine with a region encoding for a codon optimized gD protein from HSV2, described in Yang and Mauro, with the LNP presented in Drummond, with a reasonable expectation of success. This mRNA-LNP composition will further comprise a pharmaceutically acceptable excipient and be administered as a vaccine or medicament.
One would be motivated to do so in order to efficiently deliver the mRNA encoding the antigen for HSV2 to an immune cell with a LNP, to avoid mRNA degradation, in order to express the antigen for HSV2, to generate an immune response. This is because an LNP was known to have the function of providing efficient delivery of an mRNA coding for a gene eliciting an antigen specific response for infectious viruses as taught by Drummond (see pg. 30, line 15). This makes an mRNA-LNP composition an art-recognized goal and was deemed technically feasible as evidence by Drummond.
In view of the foregoing, claims 3, 4, 5, 6, 7, and 8 would have been prima facie obvious before the effective filing date.
Conclusion
No Claims are Allowed.
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/D.T.Y./Examiner, Art Unit 1635
/DANA H SHIN/Primary Examiner, Art Unit 1635