The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election without traverse of Group I, claims 1-18, in the reply filed on April 27, 2026 is acknowledged.
For the species election, Applicants elect SEQ ID NO: 3 (i.e. S. sonnei VapB Q12L).
Claims 19-28 are withdrawn. Claims 5-8 are also not currently being considered because the elected species is to SEQ ID NO: 3 (i.e. S. sonnei VapB Q12L). Claims 1-4, 9-18, to SEQ ID NO: 3 are under consideration.
Priority: This application is a 371 of PCT/GB2021/052124, filed August 17, 2021, which claims benefit to foreign application GB 2012839.3, filed August 17, 2020. A copy of the foreign priority document has been received in the instant application on February 16, 2023 and is in the English language.
Information Disclosure Statement
The information disclosure statement filed January 13, 2026 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Any IDS filed under §1.97 on or after January 19, 2025, is subject to the new rules (i.e. size fee and size fee assertion requirements).
Failure to Comply with Sequence Rules
Where the description of a patent application discusses a sequence of 4 or more amino acids or a sequence of 10 or more nucleic acids, reference must be made to the sequence by use of the sequence identifier preceded by “SEQ ID NO:” in the text of the description even if the sequence is also embedded in the text of the description of the patent application (see 37 CFR 1.821, especially paragraphs (a)-(d)). The sequence identifier may be used in either the drawing or the Brief Description of Drawings (see MPEP 2422).
Objection to the Specification:
The specification is objected to for failure to comply with the sequence rules for the
reasons as given above. The specification refers to sequences without identifiers at: see at least supplemental Table 2 listing primers used in this study (of the application publication US 20230399650); p. 20 paragraph 0246 (of the application publication US 20230399650).
The sequences must be in computer readable form (CRF) for search. See also MPEP
2422 for sequence compliance requirements. Appropriate correction is required.
Objection to the Drawings:
The drawings are objected to because at least Fig. 5 depicts sequences without corresponding SEQ ID NOS. The sequences must be in computer readable form (CRF) for search. See MPEP 2422 for sequence compliance requirements. Appropriate correction is required.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code: see at least paragraph 0091 (of the application publication US 20230399650). 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.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 9-18 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. The instant claims are product claims reciting a plasmid or nucleic acid molecules encoding a bacterial VapBC toxin-antitoxin system and a bacterial host cell comprising the plasmid that are not markedly different from a naturally occurring plasmid encoding a bacterial VapBC toxin-antitoxin system and in a naturally occurring bacterial host cell.
The claims recite a plasmid or nucleic acid molecules encoding a bacterial VapBC toxin-antitoxin system, wherein the VapBC toxin-antitoxin system comprises a modified VapB amino acid sequence, wherein the modification to VapB comprises a substitution at position Q12 (claims 1-3, 9-13, 16, 17-18) and a bacterial host cell comprising the plasmid (claims 14-15). The claims recite nucleic acid molecules encoding a bacterial VapBC toxin-antitoxin system comprising a VapB amino acid sequence that are the same as naturally occurring nucleic acid molecules and encoding the same bacterial VapBC toxin-antitoxin system comprising the same VapB amino acid sequence. The claims are directed to a statutory category, i.e. a composition of matter (step 1: YES).
Since the claims recite a nature-based product, i.e. a plasmid or nucleic acid molecules encoding a bacterial VapBC toxin-antitoxin system, wherein the VapBC toxin-antitoxin system comprises a modified VapB amino acid sequence, wherein the modification to VapB comprises amino acid substitution Q12L, the claims are analyzed to determine whether it is directed to any judicial exception. The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claims to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. The recited plasmid or nucleic acid molecules encoding a bacterial VapBC toxin-antitoxin system comprising a modified VapB amino acid sequence comprising amino acid substitution Q12L and bacterial host cell comprising the noted plasmid are compared to its closest naturally occurring counterpart(s) to determine if it has markedly different characteristics. Here, the closest natural counterpart is naturally occurring plasmid or nucleic acid molecules encoding a bacterial VapBC toxin-antitoxin system comprising a VapB amino acid sequence comprising amino acid residue L at position 12 in a bacterial host cell. When the claimed plasmid is compared to this counterpart, the comparison indicates that there are no differences in structure, function, or other characteristics. As disclosed in the instant specification, Shigella spp. comprises a virulence plasmid (pINV) encoding a VapBC system (paragraphs 0004, 0007 of the application publication). The instant specification discloses a natural S. sonnei disease isolate CS14 harbors a point mutation in VapB that superstabilizes pINV (paragraph 0011 of the application publication), where the VapB comprises the Q12L substitution (i.e. or amino acid residue L at position 12) (paragraph 0140 of the application publication, also Fig. 5). Angelini et al. also teach that the Shigella isolate CS14 is found naturally in the environment in people (p. 685, 688). There is no indication that the claimed plasmid and nucleic acid molecules have any structural and/or functional characteristics that are different from the naturally occurring plasmid in a Shigella isolate CS14. Therefore, the plasmid does not have markedly different characteristics from what occurs in nature and is a "product of nature" exception. Accordingly, the claim is directed to an exception (step 2A: YES).
Next, the claims as a whole are analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception(s). Claim 1 recites that the plasmid is isolated. However, the isolated plasmid or nucleic acid molecules comprise the same nucleotide sequence as the natural plasmid and encode the same VapBC toxin-antitoxin system comprising the same VapB amino acid sequence. The claims do not recite anything significantly different than the natural product, i.e. the claims do not recite elements or features that demonstrate that the claimed plasmid is markedly different from what exists in nature. Therefore, the claims as a whole add nothing significantly more to the "product of nature" itself (Step 2B: NO), and thus, the claims do not qualify as eligible subject matter.
See also Funk Brothers Seed Co., V. Kalo Inoculant Co., 333 U.S. 127, (1948) and Association for Molecular Pathology v. Myriad Genetics, Inc. 569 U.S., 133 S. Ct. 2107, 2116, 106 USPQ 2d. 1972 (2013).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 9-18 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 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.
In analyzing the claims for compliance with the written description requirements of 35 U.S.C. 112(a), a determination is made as to whether the specification contains a written description sufficient to show they had possession of the full scope of their claimed invention at the time the application was filed. The factors to be considered include disclosure of a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, and any combination thereof.
In the present situation, the claims are drawn to an isolated plasmid or nucleic acid molecules encoding a bacterial VapBC toxin-antitoxin system, wherein the VapBC toxin-antitoxin system comprises a modified VapB amino acid sequence arranged to increase the maintenance of the plasmid in a bacterial host, wherein the modification to VapB comprises a substitution of at least Q12 residue relative to Shigella sonnei wild-type VapB (SEQ ID NO: 1) or Shigella flexneri wild-type VapB (SEQ ID NO: 2), or structurally equivalent residues of Shigella sonnei wild-type VapB or Shigella flexneri wild-type VapB in a homologue thereof (claims 1-3, 9-13, 16, 17-18) and a bacterial host cell comprising the plasmid (claims 14-15).
Accordingly, the claims encompass a significantly large genus of nucleic acid molecules encoding a VapBC toxin-antitoxin system comprising a variant VapB comprising a substitution of at least Q12 residue relative to Shigella sonnei wild-type VapB (SEQ ID NO: 1) or Shigella flexneri wild-type VapB (SEQ ID NO: 2), or structurally equivalent residues of Shigella sonnei wild-type VapB or Shigella flexneri wild-type VapB in a homologue thereof, and being able to increase the maintenance of a plasmid in a bacterial host. The recited genus of biomolecules (nucleic acid molecules and proteins) is defined through their activity only and do not require any particular structure. The recited genus of modified VapB is defined through its activity only and do not require any particular structure and comprises any number or type of amino acid residues and/or substitution(s) at any location. As such the described genera are biomolecules and bacterial host cells comprising biomolecules defined solely by their functional characteristics, which is not sufficient characteristic for written description purposes. MPEP 2163.
However, the specification discloses a limited number modified VapBs in a VapBC toxin-antitoxin system encoded by nucleic acid molecules that increase the maintenance of a plasmid in a bacterial host. In particular, the specification discloses a Shigella sonnei or Shigella flexneri bacteria cell comprising a specific plasmid (pINV) encoding a VapBC toxin-antitoxin system comprising VapB comprising a specific amino acid sequence and having a specific amino acid substitution, i.e. instant SEQ ID NO: 3 (see examples). For instance, the instant specification discloses generating a set of pSTAB vectors expressing VapBQ12C or VapBL12C, where F51 and F60 were mutated to alanine, and F6 is substituted with an alanine, and where assays show that while VapBF6AC and VapBF51A, significantly stabilized pSTAB in S. flexneri, the introduction of F60A into VapBQ12C and VapBL12C did not alter plasmid stability (FIG. 4C); and that a double F51A/F60 mutant was unable to be generated (paragraph 0155 of the application publication). Therefore, the specification has only disclosed only certain modified VapBs in a VapBC toxin-antitoxin system encoded by nucleic acid molecules that increase the maintenance of a plasmid in a bacterial host.
The specification does not disclose any other modified VapB of unknown structure comprising only a substitution of at least Q12 residue relative to Shigella sonnei wild-type VapB (SEQ ID NO: 1) or Shigella flexneri wild-type VapB (SEQ ID NO: 2), or structurally equivalent residues of Shigella sonnei wild-type VapB or Shigella flexneri wild-type VapB in a homologue thereof, in a VapBC toxin-antitoxin system encoded by nucleic acid molecules, when in a bacterial host cell increase the maintenance of a plasmid in the bacterial host. The specification does not describe by other relevant identifying characteristics a representative number of additional species within the broadly claimed genus.
While the general methodology for performing mutagenesis to obtain variants of a protein and methods for performing in vitro and in vivo assays to investigate the activity of a variant protein expressed in an engineered cell are known, possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
This finding is also emphasized in Ex Parte Kubin (No. 2007-0819, Bd. Pat. App. & Int. May 31, 2007), wherein it is stated that:
“Although there is often significant overlap” between the enablement and written description requirements, “they are nonetheless independent of each other.” University of Rochester, 358 F.3d at 921, 69 USPQ2d at 1891. An “invention may be enabled even though it has not been described.” Id. Such is the situation here. While we conclude one skilled in the art would have been able to make and use the full scope of claim 73 through routine experimentation, we find Appellants did not describe the invention of claim 73 sufficiently to show they had possession of the claimed genus of nucleic acids. See, e.g., Noelle v. Lederman, 355 F.3d 1343, 1348, 69 USPQ2d 1508, 1513 (Fed. Cir. 2004) (“invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed”).
Thereby, a showing of how to potentially identify and engineer modified VapBs in a VapBC toxin-antitoxin system encoded by nucleic acid molecules that increase the maintenance of a plasmid in a bacterial host is not sufficient to establish that Applicants were in possession of the invention as broadly claimed.
The skilled artisan cannot necessarily envision the detailed structures of all modified VapBs of unknown structure comprising only a substitution of at least Q12 residue relative to Shigella sonnei wild-type VapB (SEQ ID NO: 1) or Shigella flexneri wild-type VapB (SEQ ID NO: 2), or structurally equivalent residues of Shigella sonnei wild-type VapB or Shigella flexneri wild-type VapB in a homologue thereof, in a VapBC toxin-antitoxin system encoded by nucleic acid molecules, when in a bacterial host cell will increase the maintenance of a plasmid in the bacterial host, because the specification provides no guidance as to which substitutions and/or deletions and/or additions and which amino acids are essential and critical for a modified VapB not limited by any particular structure except for one amino acid residue corresponding to position 12 relative to Shigella sonnei wild-type VapB (SEQ ID NO: 1) or Shigella flexneri wild-type VapB (SEQ ID NO: 2), or structurally equivalent residues of Shigella sonnei wild-type VapB or Shigella flexneri wild-type VapB in a homologue thereof, in a VapBC toxin-antitoxin system encoded by nucleic acid molecules, when in a bacterial host cell will increase the maintenance of a plasmid in the bacterial host, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the methods of making the claimed invention. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of making it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
Claims 1-4, 9-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a specific plasmid (pINV) encoding a VapBC toxin-antitoxin system comprising VapB comprising a specific amino acid sequence and having a specific amino acid substitution, i.e. instant SEQ ID NO: 3, does not reasonably provide enablement for all modified VapBs of unknown structure comprising only a substitution of at least Q12 residue relative to Shigella sonnei wild-type VapB (SEQ ID NO: 1) or Shigella flexneri wild-type VapB (SEQ ID NO: 2), or structurally equivalent residues of Shigella sonnei wild-type VapB or Shigella flexneri wild-type VapB in a homologue thereof, in a VapBC toxin-antitoxin system encoded by nucleic acid molecules, when in a bacterial host cell increase the maintenance of a plasmid in the bacterial host. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The scope of the instant claims is not commensurate with the enablement of the instant disclosure, because practice of the claimed invention would require undue experimentation by an artisan of ordinary skill in the art to ascertain which derivatives and/or variants of any VapB encoded by nucleic acid molecules (claim 1 and dependent claims), when in a bacterial host cell will increase the maintenance of a plasmid in the bacterial host. The claims are drawn to an isolated plasmid or nucleic acid molecules encoding a bacterial VapBC toxin-antitoxin system, wherein the VapBC toxin-antitoxin system comprises a modified VapB amino acid sequence arranged to increase the maintenance of the plasmid in a bacterial host, wherein the modification to VapB comprises a substitution of at least Q12 residue relative to Shigella sonnei wild-type VapB (SEQ ID NO: 1) or Shigella flexneri wild-type VapB (SEQ ID NO: 2), or structurally equivalent residues of Shigella sonnei wild-type VapB or Shigella flexneri wild-type VapB in a homologue thereof (claims 1-3, 9-13, 16, 17-18) and a bacterial host cell comprising the plasmid (claims 14-15). Accordingly, the claims encompass a large genus of modified VapBs and amino acid sequences having no particular structure in any combination in a VapBC toxin-antitoxin system encoded by nucleic acid molecules to increase the maintenance of a plasmid in a bacterial host. Thus, there could be a myriad of variant VapBs wherein the variant VapB may or may not have any type of relevant activity in a VapBC toxin-antitoxin system encoded by nucleic acid molecules, and further may or may not increase maintenance of a plasmid. Therefore, for the instant claimed invention, it would require an undue burden of experimentation for a skilled artisan to determine exactly which derivatives and/or variants retain which kind of activity, will increase any type of productivity, and/or increase maintenance of a plasmid in a bacterial host cell.
The factors to be considered in determining whether undue experimentation is required are summarized in In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
In the instant case the quantity of experimentation would be large and undue since there are myriad substitutions and/or deletions and/or additions and amino acid residues to choose from to obtain variants of VapB, that have relevant functionality or activity, in a VapBC toxin-antitoxin system encoded by nucleic acid molecules, to increase maintenance of a plasmid. The specification provides no guidance as to which substitutions and/or deletions and/or additions and which amino acids are essential and critical for a modified VapB of no particular structure and comprising one amino acid residue corresponding to position 12 relative to Shigella sonnei wild-type VapB (SEQ ID NO: 1) or Shigella flexneri wild-type VapB (SEQ ID NO: 2), or structurally equivalent residues of Shigella sonnei wild-type VapB or Shigella flexneri wild-type VapB in a homologue thereof, in a VapBC toxin-antitoxin system encoded by nucleic acid molecules, when in a bacterial host cell will result in increased maintenance of a plasmid in the bacterial host. The specification discloses a limited number modified VapBs in a VapBC toxin-antitoxin system encoded by nucleic acid molecules that increase the maintenance of a plasmid in a bacterial host. In particular, the specification discloses a Shigella sonnei or Shigella flexneri bacteria cell comprising a specific plasmid (pINV) encoding a VapBC toxin-antitoxin system comprising VapB comprising a specific amino acid sequence and having a specific amino acid substitution, i.e. instant SEQ ID NO: 3 (see examples). For instance, the instant specification discloses generating a set of pSTAB vectors expressing VapBQ12C or VapBL12C, where F51 and F60 were mutated to alanine, and F6 is substituted with an alanine, and where assays show that while VapBF6AC and VapBF51A, significantly stabilized pSTAB in S. flexneri, the introduction of F60A into VapBQ12C and VapBL12C did not alter plasmid stability (FIG. 4C); and that a double F51A/F60 mutant was unable to be generated (paragraph 0155 of the application publication).
The specification does not disclose any other modified VapB of unknown structure comprising only a substitution of at least Q12 residue relative to Shigella sonnei wild-type VapB (SEQ ID NO: 1) or Shigella flexneri wild-type VapB (SEQ ID NO: 2), or structurally equivalent residues of Shigella sonnei wild-type VapB or Shigella flexneri wild-type VapB in a homologue thereof, in a VapBC toxin-antitoxin system encoded by nucleic acid molecules, when in a bacterial host cell increase the maintenance of a plasmid in the bacterial host.
The nature of the invention is such that many different polypeptides that are substantially similar to a VapB may or may not retain any relevant activity to increase the maintenance of a plasmid including when in a bacterial host cell. The state of the prior art is that even proteins that are highly similar to the wild-type protein are at times not functional. The relative level of skill in this art is very high. Further, given that the broad genus of proteins recited in claims having essentially any structure while limited only by their functions, wherein the structural diversity within such genus of proteins are widely variant and diverse and that it is highly unpredictable which proteins would be functionally compatible, it would require an undue burden of experimentation for a skilled artisan to determine exactly which derivatives and/or variants retain relevant activity and would be functional in a VapBC toxin-antitoxin system encoded by nucleic acid molecules, to increase the maintenance of a plasmid including when in a bacterial host cell. The predictability as to which modified VapBs have which type of activity and/or productivity in a VapBC toxin-antitoxin system encoded by nucleic acid molecules, to increase the maintenance of a plasmid including when in a bacterial host cell, is zero.
When the factors are considered in their entirety, the Wands analysis dictates a finding of undue experimentation and thus, the claim is not enabled.
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.
Claim 16 is 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 16 is confusion because it is not sure what the claim is directed to, i.e. the isolated plasmid or a bacterial host cell. Further correction is requested.
Claim Rejections - 35 USC § 102
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.
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.
Claims 1-3, 9-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Angelini et al. (2009 Brazilian Journal of Microbiology 40: 685-692). The instant specification discloses that Shigella spp. comprises a virulence plasmid (pINV) encoding a VapBC system (paragraphs 0004, 0007 of the application publication). The instant specification discloses a natural S. sonnei disease isolate CS14 harbors a point mutation in VapB that superstabilizes pINV (paragraph 0011 of the application publication), where the VapB comprises the Q12L substitution (i.e. or amino acid residue L at position 12) (paragraph 0140 of the application publication, also Fig. 5).
Angelini et al. teach isolating a Shigella strain CS14, where the Shigella strain CS14 inherently comprises a plasmid or nucleic acid molecules (pINV) encoding a VapBC toxin-antitoxin system comprising VapB comprising a specific amino acid sequence and having a specific amino acid substitution Q12L, i.e. instant SEQ ID NO: 3 (at least p. 686-688; instant claims 14-15, 17-18).
Angelini et al. further teach extracting total DNA from the Shigella strains, including CS14 (p. 686); therefore, Angelini et al. teach isolated plasmid (pINV) encoding a VapBC toxin-antitoxin system comprising VapB comprising a specific amino acid sequence and having a specific amino acid substitution Q12L, i.e. instant SEQ ID NO: 3 (instant claims 1-3, 9-13, 16). Since claim 16, as currently written, can be directed to the isolated plasmid, Angelini et al. can be deemed to anticipate the instant claim since Angelini et al. teach extracting total DNA from the Shigella strains, including CS14 (p. 686).
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marsha Tsay whose telephone number is (571)272-2938. The examiner can normally be reached M-F.
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, Manjunath N. Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Marsha Tsay/Primary Examiner, Art Unit 1656
Prosecution Insights