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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 6, 2024 has been considered by the examiner.
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Incorporation of U.S. Provisional patent application Ser. No. 63/236,455 in paragraph [0001] of the instant published application, USPgPub 2025/0325648, is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The use of the term “GenBank”, which is a trade name or a mark used in commerce, has been noted in paragraph [0154] of this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Applicant is required to properly annotate all trade names and/or marks present in the instant specification, if any additional trade names and/or marks are discovered.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in paragraph [0202] of the instant published application. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 2, 6, and 14 are objected to because of the following informalities: multiple influenza peptides should be plural.
Claims 1-5, 14-16, and 20 are objected to because of the following informalities: “Filoviridae” should be italicized.
Claim 23 is objected to because of the following informalities: the claim lacks a period.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 28 and 29 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 28 is drawn to a method of eliciting an immune response against an influenza virus matrix 2 ectodomain peptide and/or a SARS- CoV2 Spike protein peptide comprising: providing a rVSV according to 1 and claim 29 is drawn to a method of eliciting an immune response against an influenza virus and/or a SARS-CoV2 comprising: providing a rVSV according to claim 1. Since the rVSV of claim 1 expresses one or more influenza virus matrix 2 ectodomain peptides and a SARS-CoV2 Spike protein peptide, it is unclear how an immune response would be induced against an influenza virus matrix 2 ectodomain peptide OR a SARS- CoV2 Spike protein peptide encompassed by claims 28 and 29.
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 18, 21, and 23 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 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.
It is apparent that “SP∆Ca742” and “SP∆S2A” recited in claims 18, 21, and 23 are required to practice the claimed invention because they are a necessary limitation for the success of the invention as stated in the claims. As required elements, each of the strains must be known and readily available to the public or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. Paragraph [0032] of the instant published disclosure, USPgPub 2025/0325648, states SARS-CoV2 Delta variants, “SPΔCa742” and “SPΔS2ΔC” within the VSV vector are:
“referred to herein as: rVSV-EboGPΔM-M2e/EboGPΔM-RBD, rVSV-EboGPΔM-M2e/SPΔCa742 and rVSV-EboGPΔM-M2e/SPΔS2ΔC respectively.”
“SPΔS2ΔC” is named in Figures 2-5. Example 4, beginning in paragraph [0140] discusses generating “SP∆Ca742” and “SP∆S2A” from “a new SARS-CoV-2 Delta variant (B11.617.2)”, but the exact materials and precise steps required are not provided. If “SP∆Ca742” and “SP∆S2A” are not so obtainable or available, the enablement requirements of 35 U.S.C. § 112, first paragraph, may be satisfied by a deposit of “SP∆Ca742” and “SP∆S2A” strain constructs. See 37 CFR 1.802. One cannot practice the claimed invention without the strains recited. Therefore, access to “SP∆Ca742” and “SP∆S2A” listed in claims 18, 21, and 23 are required to practice the invention. The specification does not provide a repeatable method for readily identifying the specific “SP∆Ca742” and “SP∆S2A” strains listed in claims 18, 21, and 23 without access to the viruses and they do not appear to be readily available material.
Deposit of the specific NDV strains listed in claims 3 and 24 in a recognized deposit facility would satisfy the enablement requirements of 35 U.S.C. 112, because the strains would be readily available to the public to practice the invention claimed, see 37 CFR 1.801- 37 CFR 1.809.
If a deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made at an acceptable depository and that the following criteria have been met:
(a) during the pendency of this application, access to the invention will be afforded to one determined by the Commissioner to be entitled thereto;
(b) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained for a term of at least thirty (30) years and at least five (5) years after the most recent request for the furnishing of a sample of the deposited material;
(d) a viability statement in accordance with the provisions of 37 CFR 1.807; and
(e) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.803 - 37 CFR 1.809 for additional explanation of these requirements. Applicant is reminded that 37 CFR 1.809(d) states:
(d) For each deposit made pursuant to these regulations, the specification shall contain:
(1) The accession number for the deposit;
(2) The date of the deposit;
(3) A description of the deposited biological material sufficient to specifically identify it and to permit examination; and
(4) The name and address of the depository. 37 CFR 1.809(e) further states: Any amendment required by paragraphs (d)(1), (d)(2) or (d)(4) of this section must be filed before or with the payment of the issue fee (see § 1.312). [Added, 54 FR 34882, Aug. 22, 1989, effective Jan. 1, 1990; paras. (b) and (c) revised and para. (e) added, 66 FR 21092, Apr. 27, 2001, effective May 29, 2001].
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9, 11, 15-18, 21, 23, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Mire et al. (The Journal of infectious diseases. 2015 Oct 1; 212 (suppl_2): S384-S388), Yao et al. (WO 2019/113688), Kim et al. (Molecular Therapy. 2013 Feb 1; 21 (2): 485-492), Wong et al. (The Journal of infectious diseases. 2015 Oct 1; 212 (suppl_2): S435-S442), and Case et al. (Cell host & microbe. 2020 Sep 9;28 (3): 465-474).
Mire et al. teach a single-injection, trivalent, replicating vesicular stomatitis virus (rVSV)–based vaccine vector expressing Filoviridae glycoproteins from Marburg virus (MARV), Zaire ebolavirus (ZEBOV), and Sudan ebolavirus (SEBOV): “rVSV-MARV-ZEBOV-SEBOV-GP (rVSV-MZS-GP)” in the abstract, “rVSV-MARV-ZEBOV-SEBOV-GP Recovery and Characterization”, and Figure 1A, corresponding to the replicative rVSV vector expressing at least a first and a second filovirus glycoprotein, as required in instant claims 1-6, 9, and 11. The first Filoviridae glycoprotein expressed after the rVSV matrix protein is the Zaire ebolavirus (ZEBOV) glycoprotein, as required by instant claim 4. The second Filoviridae glycoprotein expressed after the rVSV matrix protein is the Sudan ebolavirus (SEBOV) glycoprotein, as required by instant claim 15.
Mire et al. do not teach replacing a tolerated, deleted-mucin-like domain of the first Ebola glycoprotein (EBOV GP) with one or more influenza virus proteins inserted in-frame within the tolerated deletion to form fusion proteins, as required by instant claims 1, 3, 5, and 16.
Yao et al. depict and describe a dual action (rVSV)–based vaccine vector expressing
fusion proteins comprised of a peptide of interest inserted in the deletion-tolerant mucin-like domain of an Ebola Virus glycoprotein, on page 15, lines 16-25 and Figure 10C:
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Also see claims 1, 2, 5, 7, and 8. On page 13, line 23 to page 14, line 3, and page 15, lines 21-25, Yao et al. teach the polypeptide of interest is derived from an influenza virus as suitable inserted peptides and can be expressed as EBOV GP based fusion proteins.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have replaced the HIV V3 protein with an influenza protein peptide of Yao et al. within the first EBOV GP of Mire et al. to induce an immune response against influenza, see page 15, lines 21-25 of Yao et al. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have replaced the HIV V3 protein with an influenza protein peptide within the first EBOV GP of Mire et al. because Yao et al. teach placement of large polypeptides in the position of the mucin like domain of EBOV GP does not negatively impact targeting and achieves a more efficient cell entry, on page 15, lines 11-15.
Neither Mire et al. nor Yao et al. teach the peptide inserted in-frame into the deletion-tolerant mucin-like domain of a first EBOV GP is one, two, or more influenza virus matrix 2 ectodomain peptides (M2e), recited in claims 1, 2, 6, and 9, comprising at least 23 consecutive amino acids, recited in claim 7, where the one or more M2e are derived from human, avian, and one swine influenza viruses, recited in instant claims 8 and 11.
Kim et al. teach five tandem repeats of M2e derived from human, avian, and swine influenza viruses (M2e5X), see “Cells, viruses, and reagents” and “Preparation of M2e5x VLP”. In the first paragraph under the “Discussion”, Kim et al. teach M2e comprises 23 amino acid residues.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have replaced the HIV V3 protein of Yao et al. with tandem repeats of M2e derived from human, avian, and swine influenza viruses, taught by Kim et al., within the first EBOV GP of Mire et al. to induce cross-protection against various subtypes of influenza, see the title and Figures 2-8 of Kim et al. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have induced an immune response against influenza with tandem repeats of M2e derived from human, avian, and swine influenza viruses, taught by Kim et al. in the replacing the mucin-like domain of the first Ebola GP in the VSV vector of Mire et al. and Yao et al. because Wong et al. teach protection against Ebola and influenza viruses when influenza and Ebola virus glycoproteins are expressed from a recombinant VSV vector, see Figure 1 and Tables 1-2 and Yao et al. teach placement of large polypeptides in the position of the mucin like domain of EBOV GP does not negatively impact targeting and achieves a more efficient cell entry, on page 15, lines 11-15, and lists influenza peptides as suitable insertions to generate chimeric filovirus GP fusion proteins in the paragraph bridging pages 13-14.
Mire et al. do not teach replacing a tolerated, deleted-mucin-like domain of Yao et al. within the second Ebola glycoprotein (SEBOV GP) with a SARS-2 spike protein peptide comprising the receptor binding domain (RBD) inserted in-frame within the tolerated deletion to form fusion proteins, as required by instant claims 1, 3, and 16-18.
Case et al. teach inducing a neutralizing immune response after administration of a SARS-CoV-2 spike receptor binding domain (RBD), see Figures 1, 2, and 4.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have replaced the HIV V3 protein of Yao et al. with the SARS-CoV-2 spike RBD, taught by Case et al., within the second SEBOV GP of Mire et al. to induce protection against SARS-CoV-2, see the title and Figures 1, 2, and 4 of Case et al. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have replaced the HIV V3 protein of Yao et al. with the SARS-CoV-2 spike RBD, taught by Case et al., within the second SEBOV GP of Mire et al. to induce protection against SARS-CoV-2, see the title and Figures 1, 2, and 4 of Case et al. because Yao et al. teach placement of large polypeptides in the position of the mucin like domain of EBOV GP does not negatively impact targeting and achieves a more efficient cell entry, on page 15, lines 11-15; and Case et al. teach the protective immune response against SARS-CoV-2 is generated from SARS-CoV-2 RBD expressed from a VSV vector in the graphical abstract and “Generation of a VSV-eGFP-SARS-CoV-2 as a Vaccine Platform”.
Regarding a method of inducing an immune response against influenza and SARS-2 upon immunization, as required in instant claims 28 and 29, the combined teachings in the art prior to the instant effective filing date teach the following ordered structures:
Figure 1 of Mire et al. depict a VSV expressing two Ebola GPs:
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Figure 10C of Yao et al. show a VSV genome comprising an insertion of a heterologous viral peptide within the deletion-tolerant mucin-like domain of Ebola GP:
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Kim et al. teach five tandem repeats of M2e derived from human, avian, and swine influenza viruses (M2e5X) induce cross-protection against various subtypes of influenza, see the title and Figures 2-8, see “Cells, viruses, and reagents” and “Preparation of M2e5x VLP” and Wong et al. teach protection against Ebola and influenza viruses when influenza and Ebola virus glycoproteins are expressed from a recombinant VSV vector, see Figure 1 and Tables 1-2
Case et al. teach inducing a neutralizing immune response after administration of a SARS-CoV-2 spike receptor binding domain (RBD), see Figures 1, 2, and 4.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have replaced the HIV V3 protein of Yao et al. with tandem repeats of M2e derived from human, avian, and swine influenza viruses, taught by Kim et al., within the first EBOV GP of Mire et al. to induce cross-protection against various subtypes of influenza, see the title and Figures 2-8 of Kim et al and one of ordinary skill would have been motivated to have replaced the HIV V3 protein of Yao et al. with the SARS-CoV-2 spike RBD, taught by Case et al., within the second SEBOV GP of Mire et al. to induce protection against SARS-CoV-2, see the title and Figures 1, 2, and 4 of Case et al.
One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have induced an immune response against influenza, Ebola, and SARS-CoV-2 with the construct achieved with the combined teachings of Mire et al., Yao et al., Kim e al., Wong et al., and Case et al. because Mire et al. observe protection against all three heterologous filovirus proteins expressed from a VSV vector, see Figure 2; Yao et al. teach placement of large polypeptides in the position of the mucin like domain of EBOV GP does not negatively impact targeting and achieves a more efficient cell entry, on page 15, lines 11-15; claims 9, 10, 13, 15, 18, 22, and 23 of Yao et al. are drawn to a method of inducing an immune response against a peptide of interest upon immunization; Kim et al. demonstrate five tandem repeats of M2e derived from human, avian, and swine influenza viruses (M2e5X) induce cross-protection against various subtypes of influenza, see the title and Figures 2-8; Wong et al. teach protection against Ebola and influenza viruses when influenza and Ebola virus glycoproteins are expressed from a recombinant VSV vector, see Figure 1 and Tables 1-2; and Case et al. teach the protective immune response against SARS-CoV-2 is generated from SARS-CoV-2 RBD expressed from a VSV vector in the graphical abstract and “Generation of a VSV-eGFP-SARS-CoV-2 as a Vaccine Platform”.
Therefore, eliciting an immune response against influenza and SARS-2, as required in instant claims 28 and 29, upon immunization of the combined recombinant construct of Mire et al., Yao et al., Kim et al., Wong et al., and Case et al., would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date, absent evidence to the contrary.
While none of the references mention “SP∆Ca742” and “SP∆S2∆C”, recited in instant claims 18, 21, and 23, there is no repeatable method of making the instant VSV constructs claimed provided in the instant specification and the constructs do not to appear to be publicly available, as required by MPEP § 2404.01 and 37 CFR § 1.808. Since the instant material designated “SP∆Ca742” and “SP∆S2∆C” is not readily known or ascertainable to one of ordinary skill prior to the instant filing date, the VSV genome comprising a replacement of the deletion tolerant mucin-like domain with influenza M2e tandem repeats in a first Ebola GP and a replacement of the deletion tolerant mucin-like domain with SARS-CoV-2 RDB in a second Ebola GP of Mire et al., Yao et al., Kim et al., Wong et al., and Case et al., is at least substantially equivalent to the instant constructs designated as “SP∆Ca742” and “SP∆S2∆C” under In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Mire et al., Yao et al., Kim et al., Wong et al., and Case et al. as applied to claims 1-9, 11, 15-18, 21, 23, 28, and 29 above, and further in view of Stepanova et al. (Acta Naturae (англоязычная версия). 2018; 10 (1 (36)): 85-94).
See the teachings of Mire et al., Yao et al., Kim et al., Wong et al., and Case et al. above. The five tandem repeats of M2e derived from human, avian, and swine influenza viruses (M2e5X) in “Cells, viruses, and reagents” and “Preparation of M2e5x VLP” of Kim et al. are not separated by spacers, as required by instant claim 10. In addition, the M2e peptides of Kim et al. are derived from human, swine, and two avian influenza viruses, see the description under Figure 1a. Kim et al. do not suggest two human M2e peptides, as required by instant claim 12.
Figure 3 of Stepanova et al. depicts four tandem repeats of influenza M2e peptides, each separated from each other by glycine-rich linkers in the paragraph bridging the columns on page 89. The M2e peptides of Stepanova et al. include two consensus copies among human influenza viruses, see “Construction of expression vectors”.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have included two consensus M2e copies of human influenza viruses, as taught by Stepanova et al., within the at least four tandem M2e repeats in the VSV construct of Mire et al., Yao et al., Kim et al., Wong et al., and Case et al. to induce immune responses against human influenza virus consensus motifs. One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have included spacers between each of the tandem repeat M2e copies, as taught by Stepanova et al. in the VSV construct of Mire et al., Yao et al., Kim et al., Wong et al., and Case et al. to maintain intrinsic conformational integrity and immunogenicity of native M2e peptides, see the abstract, Figure 4, and the paragraph above “Production and purification of chimeric proteins”. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have included two consensus M2e copies of human influenza viruses, within the at least four tandem M2e repeats, each separated by spacers in the VSV construct of Mire et al., Yao et al., Kim et al., Wong et al., and Case et al. because Yao et al. teach placement of large polypeptides in the position of the mucin like domain of EBOV GP does not negatively impact targeting and achieves a more efficient cell entry, on page 15, lines 11-15.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Mire et al., Yao et al., Kim et al., Wong et al., and Case et al. as applied to claims 1-9, 11, 15-18, 21, 23, 28, and 29 above, and further in view of instant SEQ ID NO: 8 alignment with Geneseq db access no BIU51411 by Zhang Feb 2021.
See the teachings of Mire et al., Yao et al., Kim et al., Wong et al., and Case et al. above. None of the references teach a sequence corresponding to instant SEQ ID NO: 8, as required.
Geneseq db access no BIU51411 shares 100% sequence identity with instant SEQ ID NO: 8.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have used Geneseq db access no BIU51411 as the SARS-CoV-2 insert within the VSV construct of Mire et al., Yao et al., Kim et al., Wong et al., and Case et al. with a reasonable expectation of success because Geneseq db access no BIU51411 possesses the requisite structures to induce an immune stimulating effect as a SARS-CoV-2 vaccine component according to the description provided with the alignment.
Allowable Subject Matter
Claims 13, 14, 20, 22, and 24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art does not teach or suggest SEQ ID NOs: 6, 7, or 9-11.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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/Shanon A. Foley/Primary Examiner, Art Unit 1671
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