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
Applicant’s response filed on 08/26/2025 is duly acknowledged.
Claims 4, 8, 17, 22, 23, 28 and 31-39 were canceled on 08/14/2023 claim amendments by applicants.
Claims 1-3, 5-7, 9-16, 18-21, 24-27, 29 and 30, as currently amended (amdt. dated 08/14/2023) are pending in this application,
Election/Restrictions
Applicant’s election of Group I (claims 1-3, 5-7, 9-16, 20 and 21; directed to “A modified bacterium or derivative thereof…”, and “A vaccine composition…”) in the reply filed on 08/26/2025 (see REM, pages 1-2) is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, and did not specifically state if the election was made with or without traverse, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 18, 19, 24-27 (group II, non-elected) and claims 29 and 30 (Group III, non-elected) have been therefore withdrawn from further considerations.
Claims 1-3, 5-7, 9-16, 20 and 21 (elected invention of Group I, without traverse; directed to “A modified bacterium or derivative thereof…”, and “A vaccine composition…”), as currently amended/presented, have been examined on their merits in this action hereinafter.
Priority
This application is a 371 of PCT/US2021/031798 (filed on 05/11/2021), which
Claims domestic benefit from US PRO 63/127,712 (filed on 12/18/2020) and US PRO 63/022,746 (filed on 05/11/2020).
Objection to Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see for instances, page 69, 2nd paragraph; page 82, lines 21-22; page 93, last line; page 103, lines 19-23; page 105, line 8). 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.
Appropriate correction is required.
Claim Objections
1. Claim 2 (as presented) is objected to because of the following informalities: claim 2 recites the limitations “wherein the antigen from a Retroviridae, optionally…”, which should be amended to recite ““wherein the antigen is from a Retroviridae, optionally…”, in order to complete the recitation as intended by applicants.
In addition, claim 2 recites several abbreviations (HIV, SARS-CoV, SARS-CoV-2) that should be recited in full form, at least the first time they appear in a claim set. Appropriate correction is required.
2. Claims 3, 9, 10, 14 and 16 (as presented) are objected to because of the following informalities: claim 3 directly depends from claim 1, and recites abbreviations (SARS-CoV, SARS-CoV-2) that should be recited in full form, at least the first time they appear in a claim set. Similarly, claims 9, 10, 14 and 16 should be amended to recite full forms for the abbreviated terms (HIV, SARS-CoV, SARS-CoV-2) as applicable. 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.
1. Claims 1-3, 5-7, 9-16, 20 and 21 (as recited) are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites limitations “A modified bacterium or derivative thereof…”, which is ambiguous and confusing because it is not clear as to what exactly is encompassed by the recitation. The disclosure of record states the following in a form of non-limiting, broad definition of the term “derivative” (Specification, page 30, lines 31-33):
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It is noted that no specific guidance for the type of derivatives, and/or the step(s) for modification(s) of bacterium, antigen(s), or compounds having “similar structure” to obtain such “derivatives” have been disclosed on record. For instance, taking a certain strain of bacterium as an example, it is not clear as to what structural features (i.e. one or more nucleic acids, proteins, lipids, cellular components, etc.) have to be modified, and in what way (chemically, physically, mechanically, genetically, etc.) in order to obtain the “derivative thereof” such that it remains with “similar structure”, as broadly defined by the applicants. Thus, the metes and bounds of the claimed product as currently recited does not appear to be properly defined. Appropriate correction is required.
Claim 1, in lines 3-4, also recites limitations “viral antigen is expressed on a surface of a membrane or derivative thereof…”, which again is ambiguous and confusing (as it is unclear as to what exactly is being encompassed by the limitation of “derivative thereof”) for the same reasons, as discussed above. Appropriate correction is required.
Claims 14, 15 and 21 also recite the limitation “derivative thereof”, which are also deemed ambiguous and indefinite for the same reasons of record. Appropriate correction is required.
Since, none of the dependent claims clarify the above discussed point, they are also rejection as being indefinite for the same reasons discussed above. Appropriate correction is required.
2. Claims 14 and 15 (as recited) 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 14 and 15 recite limitations “… the HIV antigen comprises, consists essentially of, or consists of an amino acid sequence selected from the group consisting of AVGIGAVF (SEQ ID NO: 38), ALGIGAAF (SEQ ID NO: 48), AVGFGAAF (SEQ ID NO: 49), and AAGFGAMF (SEQ ID NO: 50)”, which confusing because- first of all there are only 1-49 sequences on record submitted by applicants in this application, and there is no “SEQ ID NO: 50” per se; and secondly, the specification of record on page 11 (last paragraph) states the following:
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The recitation appears to be confusing in that the specification of record does not have support for “SEQ ID NO: 50” as currently recited in claims of record (see both claim sets, dated 11/11/22 and 08/14/2023), essentially because of incorrect numbering of the amino acid sequences for SEQ ID NO: 47, 48 and 49, which are recited as SEQ ID NO: 48, 49 and 50 in claims 14 and 15. Therefore, the invention as presented in claims 14 and 15 are deemed ambiguous and indefinite. Appropriate correction is required.
For this office action, claims have been interpreted as per the disclosure of record for SEQ ID NO: 47, 48 and 49 (per instant specification, page 11, last paragraph).
3. Claims 14 and 15 (as recited) 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 14 and 15 both recite limitations “any subsequence and/or derivative thereof” (see claim 14, line 4); and “an immunogenic subsequence or derivative thereof” (see claim 15, lines 3-4, and lines 10-11), which is ambiguous because the terms “subsequence” or “immunogenic subsequence” have not been specifically defined by the applicants on record. In addition, no such specific guidance for said terms, other than the disclosed peptides with SEQ ID NOs recited on record has been provided, and therefore, it is unclear as to what exactly is meant by the terms “subsequence” or “immunogenic subsequence” in the claims as currently presented. Applicants are advised to delete said terms in the claims in order to obviate this rejection. Appropriate correction is required.
NOTE: In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 1-3, 5-7, 14-16, 20 and 21 (as presented) are rejected under 35 U.S.C. 103 as being unpatentable over Blattner et al (WO 2010/030986 A3; FOR previously made of record by examiner) taken with Hernandez et al (US 2018/0207260 A1; cited in applicant’s IDS dated 11/11/2022).
Claim 1 is directed to “A modified bacterium or derivative thereof having a reduced number of expressed genes and comprising a viral antigen, optionally an antigen from a virus with a class I fusion protein, optionally wherein the viral antigen is expressed on a surface of a membrane or derivative thereof, wherein the bacterium induces an enhanced immune response against the viral antigen when administered to a subject as compared to an immune response that would have been induced in the subject by a bacterium of the same strain that has a full complement of expressed genes.”
Claim 20 (as currently amended) is directed to “A vaccine composition comprising a modified bacterium according to claim 1 and a pharmaceutically acceptable carrier, optionally wherein the vaccine composition further comprises one or more adjuvants.”
See also limitations of dependent claims 2, 3, 5-7, 14-16 and 21.
Blattner et al (2010), while teaching clean genome bactofection (see Title, Abstract), disclose (regarding limitations of instant claims 1-3 and 5-7) a genetically modified, live invasive, reduced genome (or a multiple deletion strain, MDS) bacterium as DNA delivery vehicle (i.e. modified bacterium-based delivery of heterologous genes, “Bactofection”, such as E. coli, a gram-negative member of Enterobacteriaceae), comprising eukaryotic expression cassette comprising heterologous genes (see “Summary of the Invention” on page 4; entire section “III. Heterologous genes/antigens” starting on page 18; and Examples 4, 7, 11, for instances); wherein said genes can comprise antigens (for inducing immune response in a subject in need, i.e. as a vaccine composition) including from viruses such as human immunodeficiency virus (HIV, a retroviridae family virus; having class I fusion peptide epitope HIV-env), ebola virus, influenza virus, etc. (see paragraphs [0007 ]-[0008], [00013]-[00014], [00050], [00070], [00079], [00086], [000175], Examples 4, 7, 11, for instance); wherein the modified bacterium with reduced number of expressed genes comprises a reduction of at least 2% and up to 20% of the genome of the native parent bacterial strain (see [00014], for instance); wherein they disclose the advantageous fact that the use of non-pathogenic clean genome strain of E. coli K-12 strain as a vaccine “obviates problems associated with other live attenuated bacterial vectors such as reversion to pathogenic phenotype, acquisition of genes encoding drug resistance potential immunogenicity of the bacterial vector and requirements for repeated immunization doses” (see [00022]; see also [00074], for instance); and wherein the vaccine gene designs can be made based on the peptide sequences of the epitopes and the DNA sequences can be codon optimized for E. coli expression (see page 59, [000211], for instance).
However, a modified bacterium having a reduced number of expressed genes comprising a viral antigen (such as coronavirus, or from porcine epidemic diarrhea virus, PEDV, viruses from coronaviridae; see instant claims 3, 14-16), wherein “the bacterium induces an enhanced immune response against the viral antigen when administered to a subject as compared to an immune response that would have been induced in the subject by a bacterium of the same strain that has a full complement of expressed genes” (see instant claim 1) has not been explicitly exemplified by the disclosure and/or teachings from Blattner et al, as discussed above.
Hernandez et al (2008) disclose a PEDV viral antigen useful as a vaccine antigen to elicit an immune response (see Abstract – “The present invention relates to a vaccine for protecting a pig against diseases associated with porcine epidemic diarrhea virus. The vaccine commonly includes inactivated/killed PEDV (e.g ., chemically inactivated PED virus), and/or recombinant PEDV antigen and an adjuvant. Methods for protecting pigs against diseases associated with PEDV and methods of producing the porcine epidemic diarrhea virus vaccine are also provided”); wherein PEDV is a member of the subfamily Coronaviridae of genus Alphacoronavirus (see [0004], for instance); and wherein PEDV comprises the antigenic epitope of spike protein having SEQ ID NO: 14 (see Fig. 3, for amino acid sequence of PEDV 1251-125-10; and [0024], for instance) comprising the same antigen epitope “SFIEDLLF” (corresponding to instant SEQ ID NO: 43 sequence recited in instant claims 14-16); and wherein the immunogenic vaccine compositions can include suitable carrier (see [0083]) and adjuvant (see [0020-[0022], for instance).
Since Hernandez et al disclose the use of a bacterial vector to express the viral vaccine antigens in a bacterial host cell in vivo (see paragraph [0111] –“In other words, the present invention relates to a vector, that includes the coding sequence of any such Spike, M, E, N PEDV protein, or part thereof. Preferably, said vector is an expression vector, which allows the expression of any such Spike, M, E, and/or N PEDV protein or part of the protein. Vectors according to the invention are those which are suitable for the transfection or infection of bacterial, yeast or animal cells, in vitro or in vivo.”), it would have been obvious to one of ordinary skill in the art that the vaccine as disclosed by Hernandez et al could be considered for use as a live attenuated vaccine using a heterologous bacterial expression host. Further, since Blattner et al already disclose a modified bacteria with reduced genome content, and thus reduced expression of said genes, it would have been obvious to an artisan of ordinary skill in the art that heterologous expression of PEDV viral antigens in the modified bacteria of Blattner et al would provide suitable expression of PEDV derived spike protein antigens that would be higher (on a per cell basis, for instance) compared to a non-modified, parent bacterial cell, in turn providing the potential to induce an enhanced immune response against the viral antigen when administered to a subject in need, as compared to an immune response that would have been induced in the subject by the parent bacterium that has a full complement of expressed genes.
Therefore, when taken as a whole, the invention as claimed fails to distinguish itself over the combined teachings and/or suggestions from the cited prior art references of record.
2. Claims 9-13 (as presented) are rejected under 35 U.S.C. 103 as being unpatentable over Blattner et al (WO 2010/030986 A3; FOR previously made of record by examiner) taken with Hernandez et al (US 2018/0207260 A1; cited in applicant’s IDS dated 11/11/2022) as applied to claims 1-3, 5-7, 14-16, 20 and 21 above, and further in view of Nicolay et al (2015; NPL cited as ref. [U] on PTO 892 form).
Claims 9-13 (as currently amended/presented) have been reproduced herein below:
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The teachings and suggestions from the cited references of Blattner et al when taken with Hernandez et al as they related specifically to instant claims 1-3, 5-7, 14-16, 20 and 21 have been discussed in details above, and have been further relied upon herein in the same manner.
However, a modified bacterium wherein the viral antigen “is put on the surface of the bacterium” (i.e. cell surface display) using an autrotransporter expression vector encoding the antigen (see instant claims 11-13, in particular), has not been specifically disclosed by the teachings and/or suggestions from Blattner et al taken with Hernandez et al.
Nicolay et al (2015), while reviewing the autotransporter (AT)-based cell surface display in Gram-negative bacteria (see Title, Abstract on page 109), disclose the fact that “Autotransporters are polypeptides made up of an N-terminal signal peptide, a secreted or surface-displayed passenger domain and a membrane anchored C-terminal translocation unit. Genetic replacement of the passenger domain allows for the surface display of heterologous passengers. An autotransporter-based surface expression module essentially consists of an application-dependent promoter system, a signal peptide, a passenger domain of interest and the autotransporter translocation unit”(see Abstract); wherein such autotransporter based applications have been utilized in screening protein libraries, whole cell biocatalysis and live vaccine development (see Table 1 on pages 116-117; and section “Live vaccine development” on page 118); wherein HIV-based viral epitopes have already been used as passengers to display on cell surface (see page 118, 2nd paragraph, for instance); wherein fusion comprising AIDA-I autotransporter have been used for the purposes of displaying antigens in both E. coli and attenuated Salmonella vaccine strains (see page 119, left column 2nd paragraph; and Table 1, and cited references therein). Nicolay et al also disclose the advantages of such surface display system for live cell vaccine development, stating “The use of surface displayed epitopes is interesting mostly because of two main reasons. First, exposed epitopes are more easily accessible for the immune system. Second, bacterial cell surface components can serve as adjuvant thereby eliciting a strong immune response (Georgiou et al., 1993; Georgiou et al., 1997).” (see page 118, right column, 1st paragraph, for instance).
Thus, given the details and advantages of using cell surface display systems that utilize autotransporter-based constructs (see teachings of Nicolay et al, above) for selective display of immunogenic epitopes for live cell vaccine development using gram-negative bacteria (such as E. coli) as delivery vectors, it would have been obvious to an artisan of ordinary skill in the art to employ such autotransporter constructs (such as using AIDA-I AT) in order to effectively display viral immunogenic antigens on the surface of reduced genome bacterial cells (as taught specifically by Blattner et al, above) in order to use them as vaccine components and in order to enhance the immunogenicity of the vaccine composition, as already suggested by Nicolay et al (see page 118, right column, 1st and 2nd paragraphs). Such modification for the advantages of employing autotransporter constructs (that comprise AIDA-I AT, for instance) as disclosed by Nicolay et al would have been obvious and fully contemplated by an artisan of ordinary skill in the art given the detailed combined disclosure from the cited prior art references of Blattner et al taken with Hernandez et al, as discussed above.
Thus, the claim as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as claimed.
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
1. Claims 1-3, 5-7, 9-16, 20 and 21 (as presented) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1 and 14 of co-pending Application No. 17/272,199 (reference application; filed in US on 02/26/2021 by common inventors and assignee). Although the claims at issue are not identical, they are not patentably distinct from each other because claims of the co-pending application ‘199 are also directed to products in the form of “A modified bacterium…” and “An immunogen composition..” comprising said bacterium, as reproduced hereinbelow:
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Since, claims 1 and 14 as directed to product compositions that are deemed a species of the generic products as currently claimed in the instant application (see claim 1 of co-pending ‘199 for the limitations of specific heterologous antigen MPER peptide, or a HIV fusion peptide, and an autotransporter (AT) expression vector, and bacterial fragment, a bleb, a vesicle, or a minicell), and therefore an ODP rejection is deemed proper.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2. Claims 1-3, 5-7, 9-16, 20 and 21 (as presented) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1 and 15 of co-pending Application No. 17/769,899 (reference application; filed in US on 04/18/2022 by common inventor and assignee). Although the claims at issue are not identical, they are not patentably distinct from each other because conflicting claims in the co-pending application ‘899 are also directed to essentially similar products in the form of “A modified bacterium…” and “A vaccine composition…” as reproduced hereinbelow:
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Since, claims 1 and 15 of the co-pending application ‘899, as currently directed to product compositions that are deemed species of the generic products (see limitations of “a reduction of at least about 1.0% of genes and …expressed on the surface of the bacterium”) as currently claimed in the instant application, an ODP rejection is deemed proper.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
NO claims are currently allowed.
Pertinent Prior Art:
1. MENG et al. (2008; NPL cited as ref. [V] on PTO 892 form)- “Repetitive Architecture of the Haemophilus influenzae Hia Trimeric Autotransporter”, J. Mol. Biol., (2008) vol. 384, pages 824–836 (disclose the structural details of the trimeric autotransporter Hia from Haemophilus influenzae; see Abstract, Introduction and Figure 1, for instance).
2. ZEICHNER et al. (WO 2020/046982 A1; FOR cited as ref. [N] on PTO 892 form)- “COMPOSITIONS AND METHODS FOR PREVENTING AND TREATING VIRUS INFECTION” (disclose bacteria-based HIV MPER epitope vaccine candidates, wherein the antigen are displayed on the surface of gram-negative bacteria such as Salmonella sp., using autotransporter expression constructs, wherein bacteria expressing MPER-derived antigens induced enhanced immune response in mice; however, they do not disclose the use of bacteria that are genome-reduced, or have reduced number of expressed genes, per se; see Abstract, Summary, and Claims, for instance).
3. Sequence Homology:
RESULT 6 (A_GenSeq database Homology for SEQ ID NO: 43)
ABY01607
(NOTE: this sequence has 17 duplicates in the database searched.
See complete list at the end of this report)
ID ABY01607 standard; peptide; 10 AA.
XX
AC ABY01607;
XX
DT 16-JUN-2005 (first entry)
XX
DE SARS coronavirus spike protein HLA A 1101 T-cell epitope, SEQ:8235.
XX
KW Vaccine; nucleic acid vaccine; drug screening; diagnosis;
KW SARS coronavirus infection; infection; respiratory disease; virucide.
XX
OS SARS coronavirus.
XX
CC PN WO2004092360-A2.
XX
CC PD 28-OCT-2004.
XX
CC PF 09-APR-2004; 2004WO-US011710.
XX
PR 10-APR-2003; 2003US-0462218P.
PR 11-APR-2003; 2003US-0462465P.
PR 12-APR-2003; 2003US-0462418P.
PR 13-APR-2003; 2003US-0462748P.
PR 14-APR-2003; 2003US-0463109P.
PR 15-APR-2003; 2003US-0463460P.
PR 16-APR-2003; 2003US-0463668P.
PR 17-APR-2003; 2003US-0463983P.
PR 18-APR-2003; 2003US-0463971P.
PR 22-APR-2003; 2003US-0464838P.
PR 22-APR-2003; 2003US-0464899P.
PR 23-APR-2003; 2003US-0465273P.
PR 24-APR-2003; 2003US-0465535P.
PR 05-MAY-2003; 2003US-0468312P.
PR 22-MAY-2003; 2003US-0473144P.
PR 14-AUG-2003; 2003US-0495024P.
PR 23-SEP-2003; 2003US-0505652P.
PR 11-OCT-2003; 2003US-0510781P.
PR 11-DEC-2003; 2003US-0529464P.
PR 12-JAN-2004; 2004US-0536177P.
PR 07-APR-2004; 2004US-0560757P.
XX
CC PA (CHIR ) CHIRON CORP.
XX
CC PI Rappuoli R, Masignani V, Stadler K, Gregersen J, Chien D, Han J;
CC PI Polo J, Weiner A, Houghton M, Song HC, Seo MY, Donnelly JJ;
CC PI Klenk HD, Valiante N;
XX
DR WPI; 2004-766863/75.
XX
CC PT Novel isolated polypeptide e.g. spike polypeptide, Env polypeptide, of
CC PT severe acute respiratory syndrome virus (SARS), useful as vaccine for
CC PT SARS.
XX
CC PS Disclosure; SEQ ID NO 8235; 839pp; English.
XX
CC The invention relates to isolated polypeptides of the severe acute
CC respiratory syndrome (SARS) coronavirus. The polypeptides include spike
CC (S or E2), env (E or sM), membrane (M or E1), hemagglutinin-esterase (HE
CC or E3), and nucleocapsid (N) polypeptides, and the ORF1a and ORF1ab
CC (replicase) polypeptides and their proteolytic fragments. The invention
CC also relates to antibodies which recognise the polypeptides; nucleic
CC acids encoding the SARS virus polypeptides; primers specific for SARS
CC virus nucleic acid sequences; kits for amplifying SARS virus target
CC nucleic acids; a double-stranded RNA molecule 10-30 nucleotides in length
CC which is able to inactivate the SARS virus in a mammalian cell; an
CC expression construct for recombinant expression of a SARS virus spike
CC protein; a viral vector for in vivo delivery of a SARS virus polypeptide-
CC encoding nucleic acid; and a mammalian cell line stably expressing a SARS
CC viral antigen. The invention additionally provides a vaccine for the
CC treatment or prevention of SARS comprising an inactivated SARS virus, a
CC killed SARS virus, an attenuated SARS virus, a split SARS virus
CC preparation, or at least one purified SARS virus antigens; methods of
CC making inactivated SARS virus and vaccines containing it; an alpha-virus
CC replicon particle comprising one or more SARS viral antigens; and a
CC vaccine comprising one or more SARS virus antigens and one or more
CC respiratory virus antigens. The invention further encompasses a method of
CC identifying a therapeutically active agent by measuring the effect of the
CC agent on a SARS-related enzyme, and a method of treating a SARS patient
CC using small molecule viral inhibitors. The SARS virus polypeptides and
CC nucleic acids can be used in the preparation and manufacture of vaccines
CC for the treatment or prevention of SARS. The SARS virus polypeptides,
CC antibodies against them, and SARS virus-specific primers and kits
CC containing them are useful for diagnosing or identifying the presence of
CC SARS in a biological sample. The present sequence represents a SARS
CC coronavirus T-cell epitope. Note: The sequence data for this patent did
CC not form part of the printed specification, but was obtained in
CC electronic format directly from WIPO at
CC ftp.wipo.int/pub/published_pct_sequences
XX
SQ Sequence 10 AA;
Query Match 100.0%; Score 39; Length 10;
Best Local Similarity 100.0%;
Matches 8; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 SFIEDLLF 8
||||||||
Db 1 SFIEDLLF 8
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657