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 05/04/2025 is duly acknowledged.
Claims 4, 8, 17, 22, 23, 28 and 31-39 were canceled by applicants.
Claims 1-3, 5-7, 9-16, 18-21, 24-27, 29 and 30 as currently amended/presented are pending in this application,
Claims 18, 19, 24-27 (group II, non-elected) and claims 29 and 30 (Group III, non-elected) remain withdrawn.
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Objection to Specification - Withdrawn
In view of current amendments to Specification submitted by applicants on 05/04/2026, the objection to specification, as previously made by the examiner, has been withdrawn.
Claim Objections - Withdrawn
In view of current amendments to claim 2, the claim objections as previously made by the examiner, has been withdrawn.
Claim Rejections - 35 USC § 112- Withdrawn
In view of current amendments to claims 1, 14, 15 and 21, and explanation provided on record by applicant’s response (see REM dated 05/04/2026, p. 12-13), the 112b rejections over claims 1-3, 5-7, 9-16, 20 and 21, as previously made by the examiner, have been withdrawn.
Claim Rejections - 35 USC § 103 - Withdrawn
In view of current amendments to claims, the previous 103(a) rejections of record have been withdrawn.
However, the following contains new grounds of objections/rejections necessitated by applicant’s current amendments to pending claims.
Claim Rejections - 35 USC § 112 -New Matter Issue
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.
Claim 21 (as currently amended) is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 (as currently amended) is reproduced below:
“21. (Currently Amended) The vaccine composition of claim 20, wherein the vaccine composition is a killed whole genome-reduced bacterial cell vaccine
It is to be noted that the disclosure of record provides only support for the “killed whole cell” bacterial vaccine, wherein maximum of about 29.7% of the genome has been reduced/deleted for expressed genes (see SPEC, p. 3, 3rd paragraph; p. 7, last paragraph; Figures 3-4, for instance), and does not disclose the use of bacterial cells or derivatives thereof that have been deleted for the entire genome, as currently recited in instant claim 21. Also, the limitation “whole genome-reduced bacterial cell” has not been defined by applicants on record. Insertion of this limitation does not have support in the as-filed specification. The insertion of this limitation is a new concept because it neither has literal support in the as-filed specification by way of generic disclosure, nor are there specific examples of the newly limited genus which would show possession of the concept of using bacterial cells that have been deleted for their entire genome per se. The exemplified genome-reduced bacterial cells used by the applicants with maximum genome deletion are a “29.7% genome-reduced E. coli (ME5125)” (see p. 9, 1st paragraph; Figure 7). This is not sufficient support for the new genus as currently recited in the claim 21 (i.e. “killed whole genome-reduced bacterial cell vaccine”). This is a matter of written description, not a question of what one of skill in the art would or would not have known. The material within the four corners of the as-filed specification must lead to the generic concept. If it does not, the material is new matter. Declarations and new references cannot demonstrate possession of a concept after the fact. Thus, the insertion of the above mentioned limitation in claim 21 is considered to be the insertion of new matter for the above reason. Appropriate correction is required.
Applicants are suggested to amend claim 21 to recite “killed whole cell, genome-reduced bacterial vaccine” instead (i.e. that indicates use of “killed whole bacterial cells” for vaccine purposes) in order to obviate the above rejection.
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 – New Grounds
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, 9-16, 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) and Zeichner et al. (WO 2020/046982 A1; FOR previously cited by examiner as pertinent prior art).
Claim 1 (as currently amended) is directed to “A modified bacterium or derivative thereof having a reduced number of expressed genes and comprising a viral antigen, wherein the modified bacterium or derivative thereof is a killed bacterium, the reduced number of expressed genes comprise a reduction of at least 1.0%, 2.0%, 3.0%, 4.0%, 5.0%, 6.0%, 7.0%, 8.0%, 9.0%, 10%, 11%, 12%, 13%, 14%, 15%, or greater than 15% of genes such that 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 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.”
Claim 21 (as currently amended) is directed to “The vaccine composition of claim 20, wherein the vaccine composition is a killed whole genome-reduced bacterial cell vaccine
See also limitations of dependent claims 2, 3, 5-7 and 9-16 (and 112 as discussed rejection above).
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% to 20% of the genome of the native parent bacterial strain, and may be engineered to be less than 20% smaller, or with only minimal or reduced genome constructed by assembling essential genes into artificial, clean genome, which can be used to replace an existing genome in a bacterium or to create a bacterium de novo (see [00014], [00040]-[00041], for instance); wherein “the clean genome bacterium have a genome that is at least two percent (2%), preferably over five percent (5%), more preferably over seven percent (7%) to eight percent (8%) to fourteen percent (14%) to eighteen percent (18%) to twenty percent (20%), to forty percent (40%) to sixty percent (60%) smaller than the genome of its native parental strain” (see [00040]-[00041], for instance); wherein they also 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 modified bacterium or derivative thereof is a killed bacterium”; 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 claims 1 and 21, as currently amended); and wherein the viral antigen “is put on the surface of the bacterium” using an autrotransporter expression vector encoding the antigen (see instant claims 11-13, in particular), 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). Thus, 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.”), making it obvious to an artisan of ordinary skill in the art that the viral vaccine as disclosed by Hernandez et al could be considered for use as an attenuated vaccine using a heterologous bacterial expression host.
However, Hernandez et al do not explicitly disclose “killed whole bacterial cells” as viral vaccine that uses autotransporter for surface expression of viral antigens in bacteria, as currently recited in instant claim 1 and 21, as amended.
Zeichner et al (5th March, 2020), while teaching compositions and methods for preventing and treating viral infections (see Title, Abstract, and Summary starting on p. 2; claim 15, for instance), disclose the use of killed whole cell as well as live attenuated bacterial vaccines (such as Salmonella expressing the MPER derived antigens on their surface; see Abstract) expressing viral antigens, disclosed as a new approach to inexpensive, rapidly produced and globally appropriate, HIV vaccine development using currently available techniques; wherein modified bacteria (or derivative thereof) express MPER-derived viral antigens on their surfaces using Gram- autotransporters, including trimeric Haemophilus influenzae (Hia) autotransporters (see p. 35, 2nd paragraph; and p. 88, last full paragraph); Wherein “when the bacteria expressing the MPER-derived antigens on their surfaces are used to immunize mice they elicit the production of sera and vaginal wash material that bind the bacteria expressing the MPER antigens…” (see p. 89, 1st paragraph; and Figures 4-5, for instance).
Thus, given the detailed teachings from Hernandez et al (as discussed above) taken with the disclosure from Zeichner et al for the use of killed while bacterial cells expressing viral antigens as vaccine candidates that have been demonstrated to induce immune response and anti-viral neutralizing antibody activity in animals, it would have been obvious to an artisan of ordinary skill in the art to modify the genome-reduced bacteria disclosed by Blattner et al in order to obtain a modified bacterium or derivative thereof that express viral antigens (with the help of Gram- autotransporter expression vector; see Zeichner et al, Example 3, for instance) for use as vaccine, including killed whole bacterial cell vaccines (or live attenuated bacterial vaccine) as already demonstrated by Zeichner et al, as per need. 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 (or HIV antigens as disclosed by Zeichner et al discussed above) in the modified bacteria of Blattner et al would provide suitable expression of PEDV derived spike protein, or HIV-derived antigens that would be higher (on a per cell basis, for instance) when 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.
Given that Zeichner et al already demonstrate the use of autotransporter expression vectors that help efficiently express viral antigens on the surface of bacteria (that can be killed or used as live cell vaccine purposes), such modification for the advantages of employing autotransporter would have been obvious and fully contemplated by an artisan of ordinary skill in the art given the combined disclosure from the cited prior art references of Blattner et al taken with Hernandez et al and Zeichner 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 – Made/Maintained
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 amended/presented) are/remain 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; NOA issued by office on 04/24/2026). 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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691
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Since, issued 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 still deemed proper (also see the cited prior art references and the 103a rejection discussed above based on the disclosure from Blattner et al when taken with Hernandez et al and Zeichner et al).
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, 5 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:
1. (Previously Presented) “A modified bacterium or derivative thereof having a reduced number of expressed genes, wherein the reduced number of expressed genes comprises a reduction of at least about 1.0% of genes and wherein the bacterium is modified to have a reduction of one or more genes that encode proteins expressed on the surface of the bacterium, and comprising an antigen on a surface of a membrane or derivative thereof, wherein the bacterium induces an enhanced immune response against the 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, wherein the reduction of one or more genes that encode proteins expressed on the surface of the bacterium refers to reduced expression of one or more genes in the genome of the bacterium, and wherein the reduced expression of one or more genes yields the enhanced immunogenicity.”
5. (Previously Presented) “The modified bacterium of claim 1, wherein the reduced number of expressed genes comprises a reduction of at least about 2.0%, 3.0%, 4.0%, 5.0%, 6.0%, 7.0%, 8.0%, 9.0%, 10%, 11%, 12%, 13%, 14%, 15%, or greater than 15% of genes.”
15. (Withdrawn) “A vaccine composition comprising a modified bacterium according to claim 1 and a pharmaceutically acceptable carrier, optionally wherein the vaccine compositions further comprises one or more adjuvants.”
Since, claims 1, 5 and 15 of the co-pending application ‘899, as currently recited are directed to product compositions that are deemed co-extensive in scope with the instant claims (see limitations of “a reduction of at least about 1.0% of genes, or “greater than 15% of genes”, and …expressed on the surface of the bacterium”) in the instant application, an ODP rejection is deemed proper (see also the cited prior art references and the 103a rejection discussed above based on the disclosure from Blattner et al when taken with Hernandez et al and Zeichner et al).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner’s Response to Arguments
Applicant’s arguments with respect to pending claim(s) of record (see REM dated 05/04/2026) have been considered but are moot in view of the new grounds of objections/rejections made in this office action, as discussed in details above.
In the absence of a Terminal disclaimer, the ODP rejections of record are still deemed valid, and therefore have been made/maintained (see applicant’s REM, p. 11).
Conclusion
NO claims are currently allowed.
Pertinent Prior Art:
1. MENG et al. (2008; NPL previously made of record)- “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. 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657
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