DETAILED ACTION
Election/Restrictions
Applicant’s election of Group II, claims 2, 5, 10, 12, 13, 15, 18, 19 and 26-28, in the reply filed on 6/8/26 is acknowledged. Because applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicants are correct that claim 9 is to remain in Group III and it was a typographical error that placed it in both Groups II and III.
Claims 1, 9, 20, 22, 29 and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 112-2nd paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 5, 10, 12, 13, 15, 18, 19 and 26-28 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 2, 5, 10, 12, 13, 15, 18, 19 and 26-28 are vague and indefinite because the mere recitation of a name, i.e., at least one gene encoding a glucosyltransferase, a gene encoding an O-antigen O-acetylase, genes gtrl, gtrII, oacA, htrB gene, msbB gene, etc., to describe the invention is not sufficient to satisfy the Statute's requirement of adequately describing and setting forth the inventive concept. The claim should provide any structural properties, such as the nucleic acid sequence or the amino acid sequence that the gene encodes, which would allow one to identify the claimed bacterium without ambiguity. The mere recitation of a name does not adequately define the claimed product. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow one to identify what is being claimed. Appropriate clarification and/or correction is required.
In claim 5, it is unclear what is meant by the information in the parentheticals. The parentheticals should be removed because the claim should spell out what is intended. For example, Ia and 3b, known as serotype Ib, etc., if that is what is intended. Appropriate clarification and/or correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2, 10, 12, 13, 15, 18, 19 and 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verma et al (Gene Elsevier Amsterdam, NL, 129(1): 99-101, July 15,1993; provided by Applicants) in view of Arato et al (Microorganisms, vol. 2360, no. 9, pages 1-11, January 1, 2021; provided by Applicants) and Roberts et al (Immunol. & Medical Microbio. Vol. 45. 2005, pages 285-289; provided by Applicants).
Verma et al discloses a recombinant Shigella bacterium comprising at least one heterologous O-antigen (a S.flexneri Y strain converted to type X strain). To design a live vaccine strain against Shigellosis which would confer protection against different serotypes, a plasmid comprising glucosyltransferase gtrX was transferred into a S.flexneri live vaccine strain. The resulting strain was a hybrid strain with a mixed type of LPS, that reacted with both, anti-Y and anti-X monoclonal antibodies. Verma states, that the ability of this hybrid strain to elicit an immune response against both serotypes (Y and X) was tested in animal models. Accordingly, Verma discloses recombinant Shigella bacterium, comprising a mixture of O-antigens from two different serotypes of Shigella [paragraph 1 -paragraph 2, 2 and 4-5].
Although Verma does not disclose that the heterologous O-antigen comprising epitopes from at least two different serotypes comprises at least one hybrid O-antigen, it would be obvious that more than one plasmid encoding other Shigella modifying enzymes could be added to a Shigella strain and that thereby hybrid O-antigens could be obtained, e.g., claim 2. The examples demonstrate that hybrid RU (identical RU modified by all the complemented OAg-modifying enzymes) was only obtained with one combination of two O-Ag modifying enzymes (gtrl + gtrV) and one combination of 3 O-Ag modifying enzymes (gtrl+ gtrX + oacA).
Arato et al discloses S. flexneri 2a and 1b strains engineered to obtain differently acetylated O-Ag by knocking-out the genes for O-acetyltransferases oacB and oacD (for 2a) and for oacB (for 1b). OMVs from these strains were obtained by the same method as described in the present application and were used in a vaccine composition.
Roberts et al discloses, that serotype Y vaccine candidate SFL124 originated from a serotype 2a background, where a region of gtrll was interrupted, and that conversion from serotype 2a to Y has also been observed in other strains [p4, lines 3-5].
With respect to claim 10, the production from Shigella OMVs by the same method as used in the examples of the present application is disclosed in Arato et al [p3 4-L] and the production of OMVs from Gram-negative bacteria is well known in the prior art. Claim 15 relates to preparing a production Shigella bacterium by the deletion of one or more of the following genes: gtrl, gtrll, gtrlli, gtrV, gtrX, oacA, oacB and oacC, that are present in the native genome. Arato discloses S. flexneri 2a and 1b strains engineered to obtain differently acetylated O-Ag by knocking-out the genes for O-acetyltransferases oacB and oacD (for 2a) and for oacB (for 1b) [p3, lines 2-6]. Additionally, Roberts et al discloses, that serotype Y vaccine candidate SFL124 originated from a serotype 2a background, where a region of gtrll was interrupted, and that conversion from serotype 2a to Y has also been observed in other strains [p4, lines 3-5]. In view of Arato and Roberts it would have been prima facie obvious to one of ordinary skill in the art to modify a Shigella bacterium by deleting one or more genes present in the native genome, and further to combine this with plasmids encoding one or more of these genes as described in Verma. It is matter of a design choice wither the genes encoding the glucosyltransferase and the gene encoding O-antigen O-acetylase are on the same plasmid or different plasmids.
Status of Claims:
No claims are presently allowed.
It is suggested that claim 2 be amended to include the subject matter of claim 5 and to include the combination of two O-Ag modifying enzymes (gtrl + gtrV) and/or one combination of 3 O-Ag modifying enzymes (gtrl+ gtrX + oacA), as shown in the examples.
Prior art, not presently relied upon
CN 111 793 591 A (UNIV NANCHANG) 20 October 2020 (2020-10-20) discloses expression of the O-antigen polysaccharide of Shigella on the outer membrane of Salmonella and outer membrane vesicles (OMVs) comprising said Shigella O-Ag. Thus, it discloses an outer membrane vesicle comprising at least one heterologous O-antigen. The reference further relates to immunogenic compositions comprising the OMVs and a pharmaceutically acceptable excipient and vaccination of mice with this compositions to verify the ability of the mutant strain OMVs to induce an immune response against Shigella O-antigen.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
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/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 8/4/26
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