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 .
DETAILED ACTION
Priority
This Application is a national phase application filed under 35 U.S.C. § 371 claiming priority to International Application No. PCT/US22/80065, filed on November 17, 2022, which claims priority to U.S. Application No. 63/280,524, filed on November 17, 2021 that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 05/16/2024 is acknowledged. Claims 1-20 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/09/2024, 12/18/2024, 10/14/2025 and 07/14/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Drawings
The drawing filed on 05/16/2024 are acknowledged and accepted by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation 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.
Claims 7-9 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2163.11.A.2.(a).i) states, "Whether the specification shows that applicant was in
possession of the claimed invention is not a single, simple determination, but rather is a factual
determination reached by considering a number of factors. Factors to be considered in
determining whether there is sufficient evidence of possession include the level of skill and
knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention".
For claims drawn to a genus, MPEP § 2163 states the written description requirement
for a claimed genus may be satisfied through sufficient description of a representative number
of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant,
identifying characteristics, i.e., structure or other physical and/or chemical properties, by
functional characteristics coupled with a known or disclosed correlation between function and
structure, or by a combination of such identifying characteristics, sufficient to show the
applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at
1406. A "representative number of species" means that the species which are adequately described arerepresentative of the entire genus. Thus, when there is substantial variation within the genus, onemust describe a sufficient variety of species to reflect the variation within the genus. Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
The claims are directed a vaccine and/or immunogenic composition for preventing or treating SARS-CoV-2 infection in a subject comprising: (i) a single synthetic DNA fragment comprising the entire genome of a modified vaccinia Ankara (MVA), or two or more synthetic DNA fragments each comprising a partial sequence of the genome of the MVA such that the two or more DNA fragments, when transferred into a host cell, are assembled sequentially and comprise the full-length sequence of the MVA genome, and (ii) one or more DNA sequences encoding the spike (S) protein and the nucleocapsid (N) protein of SARS-CoV-2, subunits, or fragments thereof, inserted into one or more insertion sites of the MVA, whereby (claim 7) The vaccine and/or immunogenic composition of claim 1, wherein the DNA sequence encoding the S protein comprises a nucleotide sequence that is at least 80% identical to any one of SEQ ID NOs: 5, 9, 11, 13, 15, 21, 25, and 29; (claim 8) a synthetic modified vaccinia Ankara (sMVA) vector comprising a nucleotide sequence that is at least 80% identical to SEQ ID NOs: 7, 17, 19, 23, 27 and 31; and (claim 9) a sMVA vector comprising a nucleotide sequence that is at least 80% identical to SEQ ID NO: 33.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
The grounds for the written description rejection are as follows: The sequences consisting of a sequence that is at least 80% identity thereto can have any type of mutation (e.g., deletion, insertion, substitution), anywhere along the nucleotide sequence. Therefore, the written description is not commensurate in scope with the claims drawn to any parts or percentages of the nucleotide sequence, wherein the sequences have at least 80% identity to SEQ ID NOs: 5, 9, 11, 13, 15, 21, 25, and 29 (claim 7); SEQ ID NOs: 7, 17, 19, 23, 27 and 31 (claim 8) and SEQ ID NO: 33 (claim 9).
There is some general teaching in the art that some amino acid variations are tolerated without losing a protein' s tertiary structure, but conservation of structure is not necessarily a surrogate for conservation of function. While one of skill in the art could, with the aid of a computer as suggested, could identify the sequences that have at least 80% identity, this would not tell one the structure of the sequence having the recited functional activity of expression as an antigen. In terms of function of the genus of polypeptides, they must retain the ability to retain their immunogenicity. Applicant has not provided a structure-function nexus. The instant claims encompass a genus of sequences having alterations of any portion of SEQ ID NOs: 5, 7, 9, 11, 13, 15,17, 19, 21, 23, 25, 27, 29, 31 and 33. For example, SEQ ID NO: 5, is 3822 nucleotides (nt) long, so with 80% identity, the sequence can vary up to 764 nt(s) along the sequence, so, for substitutions alone, i.e., each position could be any one of the 4 canonical nucleic bases (not including uracil), which would encompass 7644 nucleotide sequences and need to be immunogenic to the degree of a vaccine as defined by Applicant’s disclosure. This reasoning would also apply to the fragments, which encompass any two, any three, and any four, etc. stretches along any part of the sequence, which need to retain function. Thus, it appears to permutate into an equally large genus. Accordingly, it does not appear applicants were in possession of the claimed sequences having 80% identity to SEQ ID NOs: 5, 7, 9, 11, 13, 15,17, 19, 21, 23, 25, 27, 29, 31 and 33 at the time of filing. Given that there is no identification of any particular portion of the structure that must be conserved, and in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. While it is possible to make antigenic nucleic acid sequences, the specification must provide an adequate description of the genus. The provision of a partial structure and a function without a nexus between the two does not put one in possession of the large genus of variants encompassed by the claims. Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Thus, the Applicant has not shown, otherwise, which alterations to the sequences that would retain the functional limitation of preventing an infection in the form of a vaccine. The Applicant has not provided adequate written description to support the claimed genus of the construct limited by the function of being a vaccine. In view of the lack of disclosure of how to make the composition comprising said sequences and fragments thereof, the claims are rejected as lacking adequate descriptive support for the claimed invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-14, 17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chiuppesi et al. (bioRxiv preprint doi: https://doi.org/10.1101/2020.07.01.183236; this version posted July 2, 2020).
The claims are directed to a vaccine and/or immunogenic composition for preventing or treating SARS-CoV-2 infection in a subject comprising: (i) a single synthetic DNA fragment comprising the entire genome of a modified vaccinia Ankara (MVA), or two or more synthetic DNA fragments each comprising a partial sequence of the genome of the MVA such that the two or more DNA fragments, when transferred into a host cell, are assembled sequentially and comprise the full-length sequence of the MVA genome, and (ii) one or more DNA sequences encoding the spike (S) protein and the nucleocapsid (N) protein of SARS-CoV-2, subunits, or fragments thereof, inserted into one or more insertion sites of the MVA, wherein the S protein and the N protein are expressed in the host cell upon transfection of the one or more MVA DNA fragments.
Regarding claims 1-3 and 11-12, Chiuppesi discloses "Modified Vaccinia Ankara (MVA) is a highly attenuated poxvirus vector that is widely used to develop vaccines for infectious diseases and cancer. We demonstrate the construction of a vaccine platform based on a unique three-plasmid system to efficiently generate recombinant MVA vectors from chemically synthesized DNA. In response to the ongoing global pandemic caused by SARS coronavirus-2 (SARS-CoV-2), we use this vaccine platform to rapidly produce fully synthetic MVA (sMVA) vectors co-expressing SARS-CoV-2 spike and nucleocapsid antigens, two immunodominant antigens implicated in protective immunity. We show that mice immunized with these sMVA vectors develop robust SARS-CoV-2 antigen-specific humoral and cellular immune responses, including potent neutralizing antibodies” (see the Abstract) (instant claims 1 and 11-12), Chiuppesi discloses the insertion sites comprise Del2, Del2 and/or IGR69/70 (Figure 1) (instant claim 2). Chiuppesi discloses that the sMVA vectors can be used to treat COVID-19 or induce robust humoral and cellular immune responses to S and N antigens and that the sequences are under control of an mH5 promoter (Introduction and Figures 4B below and 5) (instant claim 3).
PNG
media_image1.png
399
349
media_image1.png
Greyscale
Regarding claims 4-9 and 13-14, Chiuppesi teaches the synthetic modified vaccinia Ankara (sMVA) vector or virus capable of expressing one or more DNA sequences encoding a spike (S) protein and a nucleocapsid (N) protein and discloses that “the S and N antigen sequences were based on the SARS-CoV-2 reference strain (NCBI Accession# NC_045512)”, i.e. Wuhan-Hu-1, and “codon-optimized for Vaccinia” (page 16 first para. and Figure 1) (instant claim 9), hence, the composition and methods of Chiuppesi meet the limitations of claims 5-9 (including recited % sequence identities) as the Wuhan-Hu-1 strain (NC 045512) encompasses the claimed SEQ ID NOs and/or a variant of concern (VOC) (instant claims 4-8 and 13-14).
Regarding claim 10, Chiuppesi discloses the composition comprises an additive (page 6, last para. to page 7, first para.).
Regarding claims 17 and 19, Chiuppesi discloses a two-dose administration of the composition (page 22 first para.).
Therefore, the cited prior art anticipates the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 15-16, 18 and 20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Chiuppesi et al. (bioRxiv preprint doi: https://doi.org/10.1101/2020.07.01.183236; this version posted July 2, 2020). The teachings of Chiuppesi et al. are outlined above and incorporated herein.
The claims are directed to the vaccine and/or immunogenic composition being administered by intramuscular injection, intranasal, intradermal and/or scarification (claim 15); a single dose (claim 16); three or more doses (claim 18); and two or more booster doses (claim 20).
Regarding claims 15-16, 18 and 20, Chiuppesi does not teach the limitations of claims 15-16, 18 and 20. However, according to section 2144.05 of the MPEP, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.")
In the instant application, the conditions [administration route, number of doses, dosing protocol] used by Chiuppesi et al. were sufficient to induce robust SARS-CoV-2 antigen-specific humoral and cellular immune responses. Therefore, determining other optimum or workable routes of administration, number of dosages and dosing protocols is routine experimentation. Further, applicant has not demonstrated unexpected or superior results using the recited administration routes (claim 15), a single dose (claim 16), different dosing protocols (claims 18 and 20).
Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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 Langi, 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
on line using web-screens. An eTerminal Disclaimer that meets all requirements is autoprocessed
and approved immediately upon submission. For more information about eTerminal
Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 11-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7-11 and 15 of copending Application No. 18/711,338. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are directed to a method of preventing, treating SARS-CoV-2 infection, or eliciting an immune response to SARS-CoV-2 in a subject comprising administering a prophylactically or therapeutically effective amount of a vaccine and/or immunogenic composition to the subject, wherein the vaccine and/or immunogenic composition comprises:
(i) a single synthetic DNA fragment comprising the entire genome of a modified vaccinia Ankara (MVA), or two or more synthetic DNA fragments each comprising a partial sequence of the genome of the MVA such that the two or more DNA fragments, when transferred into a host cell, are assembled sequentially and comprise the full-length sequence of the MVA genome, and
(ii) one or more DNA sequences encoding the spike (S) protein and the nucleocapsid (N) protein of SARS-CoV-2, subunits, or fragments thereof, inserted into one or more insertion sites of the MVA, wherein the S protein and the N protein are expressed in the host cell upon transfection of the one or more MVA DNA fragments.
The copending claims are directed to: A method of vaccinating or protecting a subject against coronavirus disease 2019 (COVID-19) or preventing or reducing the severity of COVID-19 caused by a coronavirus infection or boosting an immune response to coronavirus infection in a subject, comprising administering a composition comprising a synthetic modified vaccinia Ankara (sMVA) vector or virus capable of expressing one or more DNA sequences encoding a spike (S) protein and a nucleocapsid (N) protein or variants or mutants thereof, wherein the method (i) prevents the coronavirus infection or (ii) prevents or reduces the severity of COVID-19 caused by the coronavirus infection (instant claim 11).
Instant claim 11 is taught by copending claims 1 and 5.
Instant claims 12-14 are taught by copending claim 7.
Instant claim 15 is taught by copending claim 8.
Instant claims16-20 are taught by copending claims 9-11 and 15.
There is no patentable difference between the instant claimed methods and the methods of copending Application No. 18/711,338 in that it discloses a method of preventing, treating SARS-CoV-2 infection, or eliciting an immune response to SARS-CoV-2 in a subject comprising administering a prophylactically or therapeutically effective amount of a vaccine and/or immunogenic composition to the subject comprising the same limitations of the instant application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 31 of copending Application No. 19/555,730. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are directed to a composition and method of preventing, treating SARS-CoV-2 infection, or eliciting an immune response to SARS-CoV-2 in a subject comprising administering a prophylactically or therapeutically effective amount of a vaccine and/or immunogenic composition to the subject, wherein the vaccine and/or immunogenic composition comprises:
(i) a single synthetic DNA fragment comprising the entire genome of a modified vaccinia Ankara (MVA), or two or more synthetic DNA fragments each comprising a partial sequence of the genome of the MVA such that the two or more DNA fragments, when transferred into a host cell, are assembled sequentially and comprise the full-length sequence of the MVA genome, and
(ii) one or more DNA sequences encoding the spike (S) protein and the nucleocapsid (N) protein of SARS-CoV-2, subunits, or fragments thereof, inserted into one or more insertion sites of the MVA, wherein the S protein and the N protein are expressed in the host cell upon transfection of the one or more MVA DNA fragments.
The copending claim is directed to: A system for generating a recombinant synthetic MVA (rsMVA) vector reconstituted from chemically synthesized DNA comprising three DNA fragments, F1, F2, and F3, wherein: F1 comprises (i) a first partial chemically synthesized sequence of a full-length synthetic MVA (sMVA) genome and (ii) a first DNA sequence encoding a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) Nucleocapsid (N) protein, wherein the first DNA sequence is inserted in a first insertion site of the first partial sequence of the full-length sMVA genome; F2 comprises a second partial chemically synthesized sequence of the full-length sMVA genome; and F3 comprises (i) a third partial chemically synthesized sequence of the full-length sMVA genome and (ii) a second DNA sequence encoding a SARS-CoV-2 Spike (S) protein, wherein the second DNA sequence is inserted in a second insertion site of the third partial sequence of the full-length sMVA genome; wherein each of the three DNA fragments, F1, F2, and F3, further comprise an MVA terminal hairpin loop (HL) sequence flanked by MVA concatemeric resolution (CR) sequences (CR/HL/CR) added to both ends of each DNA fragment; and
wherein F1, F2, and F3, are capable of sequentially assembling by homologous recombination to generate the rsMVA vector, the rsMVA vector comprising the full- length sMVA genome (instant claims 1 and 11).
There is no patentable difference between the instant claimed methods and the methods of copending Application No. 19/555,730 in that it discloses a method of preventing, treating SARS-CoV-2 infection, or eliciting an immune response to SARS-CoV-2 in a subject comprising administering a prophylactically or therapeutically effective amount of a vaccine and/or immunogenic composition to the subject comprising the same limitations of the instant application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 10-12 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 17/932,239. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are directed to a method of preventing, treating SARS-CoV-2 infection, or eliciting an immune response to SARS-CoV-2 in a subject comprising administering a prophylactically or therapeutically effective amount of a vaccine and/or immunogenic composition to the subject, wherein the vaccine and/or immunogenic composition comprises:
(i) a single synthetic DNA fragment comprising the entire genome of a modified vaccinia Ankara (MVA), or two or more synthetic DNA fragments each comprising a partial sequence of the genome of the MVA such that the two or more DNA fragments, when transferred into a host cell, are assembled sequentially and comprise the full-length sequence of the MVA genome, and
(ii) one or more DNA sequences encoding the spike (S) protein and the nucleocapsid (N) protein of SARS-CoV-2, subunits, or fragments thereof, inserted into one or more insertion sites of the MVA, wherein the S protein and the N protein are expressed in the host cell upon transfection of the one or more MVA DNA fragments.
The copending claims are directed to: A vaccine composition for preventing or treating a coronavirus infection in a subject comprising a recombinant synthetic modified vaccinia Ankara (rsMVA) virus reconstituted from homologous recombination of three DNA fragments, F1, F2, and F3, wherein each of F1 and F3 comprises a first heterologous DNA sequence or a second heterologous DNA sequence, and wherein the reconstituted rsMVA virus comprises:
(i) a full-length synthetic MVA (sMVA) genome; (ii) the first DNA sequence which encodes a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) Nucleocapsid (N) protein, wherein the first DNA sequence is inserted in a first insertion site of the full-length sMVA genome; and
(iii) the second DNA sequence which encodes a SARS-CoV-2 Spike (S) protein, wherein the second DNA sequence is inserted in a second insertion site of the full-length sMVA genome; wherein the vaccine composition elicits cross-reactive neutralizing activity against one or more SARS-CoV-2 variants of concern (VOC), and wherein the one or more SARS-CoV-2 VOC comprises a D614G mutation in the S protein (instant claim 1)
Instant claim 2 is taught by copending claim 2.
Instant claim 3 is taught by copending claim 3.
Instant claim 10 is taught by copending claim 4.
Instant claims 11 and 12 are taught by copending claims 1 and 7.
Instant claim 15 is taught by copending claims 5 and 6.
There is no patentable difference between the instant claimed methods and the methods of copending Application No. 17/932,239 in that it discloses a method of preventing, treating SARS-CoV-2 infection, or eliciting an immune response to SARS-CoV-2 in a subject comprising administering a prophylactically or therapeutically effective amount of a vaccine and/or immunogenic composition to the subject comprising the same limitations of the instant application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 49 and 62-63 of copending Application No. 17/999,170. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are directed to a method of preventing, treating SARS-CoV-2 infection, or eliciting an immune response to SARS-CoV-2 in a subject comprising administering a prophylactically or therapeutically effective amount of a vaccine and/or immunogenic composition to the subject, wherein the vaccine and/or immunogenic composition comprises:
(i) a single synthetic DNA fragment comprising the entire genome of a modified vaccinia Ankara (MVA), or two or more synthetic DNA fragments each comprising a partial sequence of the genome of the MVA such that the two or more DNA fragments, when transferred into a host cell, are assembled sequentially and comprise the full-length sequence of the MVA genome, and
(ii) one or more DNA sequences encoding the spike (S) protein and the nucleocapsid (N) protein of SARS-CoV-2, subunits, or fragments thereof, inserted into one or more insertion sites of the MVA, wherein the S protein and the N protein are expressed in the host cell upon transfection of the one or more MVA DNA fragments.
The copending claims are directed to: A plasmid system for generating a recombinant synthetic MVA (rsMVA) vector reconstituted from chemically synthesized DNA comprising three DNA fragments, F1, F2, and F3, wherein F1 comprises (i) a first partial chemically synthesized sequence of a full- length synthetic MVA (sMVA) genome and-the (ii) a first DNA sequence encoding a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) Nucleocapsid (N) protein having an amino acid sequence comprising SEQ ID NO:10, wherein the first DNA sequence is inserted in a first insertion site of the first partial sequence of the full-length sMVA genome; F2 comprises a second partial chemically synthesized sequence of the full- length sMVA genome; and F3 comprises (i) a third partial chemically synthesized sequence of the full- length sMVA genome and the (ii) a second DNA sequence encoding a SARS-CoV-2 Spike (S) protein, wherein the second DNA sequence is inserted in a second insertion site of the third partial sequence of the full-length sMVA genome; and wherein each of the three DNA fragments, F1, F2, and F3, further comprise an MVA terminal hairpin loop (HL) sequence flanked by MVA concatemeric resolution (CR) sequences (CR/HL/CR) is added to both ends of each DNA fragment and wherein F1, F2, and F3 are capable of sequentially assembling by homologous recombination to generate the rsMVA vector, the rsMVA vector comprising the full-length sMVA genome (instant claim 1).
Instant claims 2 is taught by copending claims 62 and 63.
There is no patentable difference between the instant claimed methods and the methods of copending Application No. 17/932,239 in that it discloses a method of preventing, treating SARS-CoV-2 infection, or eliciting an immune response to SARS-CoV-2 in a subject comprising administering a prophylactically or therapeutically effective amount of a vaccine and/or immunogenic composition to the subject. Although the claims at issue are not identical copending claim 49 anticipates the limitations of the instant application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 10-12 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 12/584,146. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another.
The instant claims are directed to a method of preventing, treating SARS-CoV-2 infection, or eliciting an immune response to SARS-CoV-2 in a subject comprising administering a prophylactically or therapeutically effective amount of a vaccine and/or immunogenic composition to the subject, wherein the vaccine and/or immunogenic composition comprises:
(i) a single synthetic DNA fragment comprising the entire genome of a modified vaccinia Ankara (MVA), or two or more synthetic DNA fragments each comprising a partial sequence of the genome of the MVA such that the two or more DNA fragments, when transferred into a host cell, are assembled sequentially and comprise the full-length sequence of the MVA genome, and
(ii) one or more DNA sequences encoding the spike (S) protein and the nucleocapsid (N) protein of SARS-CoV-2, subunits, or fragments thereof, inserted into one or more insertion sites of the MVA, wherein the S protein and the N protein are expressed in the host cell upon transfection of the one or more MVA DNA fragments.
The copending claims are directed to: A vaccine composition comprising a reconstituted recombinant synthetic modified vaccinia Ankara (rsMVA) virus, the rsMVA comprising: (i) a full-length synthetic MVA (sMVA) genome; (ii) a first DNA sequence encoding a severe acute respiratory syndrome coronavirus-2 (SARS-COV-2) Nucleocapsid (N) protein, wherein the first DNA sequence is inserted in a first insertion site of the full-length sMVA genome; and (iii) a second DNA sequence encoding a SARS-COV-2 Spike(S) protein, wherein the second DNA sequence is inserted in a second insertion site of the full-length sMVA genome, wherein the first DNA sequence encodes an amino acid sequence of SEQ ID NO: 10, and
wherein the rsMVA is reconstituted from homologous recombination of three DNA fragments, F1, F2, and F3, wherein: F1 comprises a first partial sequence of the full-length sMVA genome and the first DNA sequence encoding the SARS-COV-2 N protein; F2 comprises a second partial sequence of the full-length sMVA genome; and F3 comprises a third partial sequence of the full-length sMVA genome and the second DNA sequence encoding SARS-COV-2 S protein; and wherein an MVA terminal hairpin loop (HL) sequence flanked by MVA concatemeric resolution (CR) sequences (CR/HL/CR) is added to both ends of each of F1, F2, and F3.
Instant claim 2 is taught by copending claim 2.
Instant claim 3 is taught by copending claim 3.
Instant claim 10 is taught by copending claim 4.
Instant claims 11 and 12 are taught by copending claims 1 and 7.
Instant claim 15 is taught by copending claims 5 and 6.
There is no patentable difference between the instant claimed methods and the methods of copending Application No. 17/932,239 in that it discloses a method of preventing, treating SARS-CoV-2 infection, or eliciting an immune response to SARS-CoV-2 in a subject comprising administering a prophylactically or therapeutically effective amount of a vaccine and/or immunogenic composition to the subject comprising the same limitations of the instant application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4-6, 15 and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19-22 of copending Application No. 18/711,088. Although the claims at issue are not identical, they are not patentably distinct from each other because they are not patentably distinct from each other because the claims are coextensive in scope and species with one another. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are directed to a method of preventing, treating SARS-CoV-2 infection, or eliciting an immune response to SARS-CoV-2 in a subject comprising administering a prophylactically or therapeutically effective amount of a vaccine and/or immunogenic composition to the subject, wherein the vaccine and/or immunogenic composition comprises:
(i) a single synthetic DNA fragment comprising the entire genome of a modified vaccinia Ankara (MVA), or two or more synthetic DNA fragments each comprising a partial sequence of the genome of the MVA such that the two or more DNA fragments, when transferred into a host cell, are assembled sequentially and comprise the full-length sequence of the MVA genome, and
(ii) one or more DNA sequences encoding the spike (S) protein and the nucleocapsid (N) protein of SARS-CoV-2, subunits, or fragments thereof, inserted into one or more insertion sites of the MVA, wherein the S protein and the N protein are expressed in the host cell upon transfection of the one or more MVA DNA fragments.
The copending claims are directed to: A method of vaccinating or protecting a subject against coronavirus disease 2019 (COVID-19); preventing a coronavirus infection; preventing, treating, or reducing the severity of COVID-19; or treating COVID-19 caused by a coronavirus infection, comprising administering to the subject a composition comprising a synthetic MVA (sMVA) vector comprising or capable of expressing one or more DNA sequences encoding a spike (S) protein and a nucleocapsid (N) protein or variants or mutants thereof, wherein the subject is a blood cancer patient that (1) has been treated for a hematological malignancy with a cellular therapy or (2) has had or is likely to have a poor immune response to a different COVID-19 vaccination. (instant claim 1).
Instant claims 4-6 is taught by copending claim 19.
Instant claim 15 is taught by copending claim 20.
Instant claims 19 and 20 are taught by copending claims 21 and 22.
There is no patentable difference between the instant claimed methods and the methods of copending Application No. 18/711,088 in that both are claiming rsMVA comprising nucleic acid encoding SARS CoV-2 proteins, namely S and N proteins. Both are claiming methods of delivering the rsMVA to elicit a protective or therapeutic immune response in a subject in need thereof. The main difference is the reference claims provide for a method of delivering the composition to a specific patient population, specifically those suffering from blood cancer. However, the method of delivering the MVA to a specific population of subjects would be obvious to a skilled artisan such that administering the composition is deemed suitable to receive such a treatment. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
Prosecution Insights