DETAILED ACTION
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 .
The preliminary amendment filed 8/1/2024 is acknowledged. Claims 1, 6-15, 19, 23, 26, 32, and 39 are amended. Claims 2-5, 16-18, 20-22, 24-25, 27-28, 33-37, and 40 are cancelled. Claims 1, 6-15, 19, 23, 26, 29-32, and 38-39 are pending and are currently under examination.
Information Disclosure Statement
The information disclosure statement filed on 1/29/2024 has been considered. A signed copy is enclosed.
Nucleotide and/or Amino Acid Sequence Disclosures
This application fails to comply with the requirements of 37 C.F.R. 1.821-1.825 because it contains amino acid sequences that are not correctly identified. The specification provides two different sequences for SEQ ID NO:3 and for SEQ ID NO:7. One of each of these does not match the sequence in the sequence listing (see Tables 8 and 9). The sequences in the specification should match the sequence listing and computer readable form (CRF) submitted with the application. Applicant is asked to review the specification for sequences that are not identified and correction is required. Applicant must provide a substitute computer readable form (CRF) copy of the “Sequence Listing”, a substitute paper copy of the “Sequence Listing”, an amendment of the specification to insert appropriate sequence identifiers, and a statement that the content of the paper and computer readable copies are the same and, where applicable, include no new matter, as required by 37 C.F.R. 1.821(e) or 1.821(f) or 1.821(g) or 1.825(b) or 1.825(d).
Claim Objections
Claims 7-14, 23, and 39 are objected to because of the following informalities: The claims contain periods within the claim. Each claim must begin with a capital letter and end with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v.Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). Appropriate correction is required.
The use of the trademark TOPO has been noted in this application on page 16. It should be capitalized wherever it appears and be accompanied by the generic terminology.
Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks.
It is noted that the cited occurrence of improper use is only exemplary and applicant should review the specification to correct any other use of trademarks.
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.
Claims 1, 6-15, 19, 23, 26, 29-32, and 38-39 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 pre-AIA the applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation serotype 01 and 02, and the claim also recites serotypes 01v1, 01v2, 02v1, and 02v2, which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 7-9 are rendered indefinite by the phrase “(encoded by both wbbN and wbbO)”. The use of parentheses makes it unclear whether this limitation is required or merely exemplary. Further, it is not clear if multiple glycosyltransferases or required or if a glycosyltransferase produced by either gene is sufficient.
Claim 10 is rendered indefinite by the phrase “(encoded by both wbbN and wbbO)” and “(please provide name)”. The use of parentheses makes it unclear whether this limitation is required or merely exemplary. Further, it is not clear if multiple glycosyltransferases or required or if a glycosyltransferase produced by either gene is sufficient. In addition, it is not clear what “please provide name” is intended to encompass.
Claims 7-10 are rendered indefinite by the phrase “FGlycosyltransferase family 2”. It is not clear what FGlycosyltransferase is and, if this is a typographical error, how this glycosyltransferase is different from the previously recited glycosyltransferase.
Claims 9-10 are indefinite because there are two glycosyltransferases recited and it is not clear if these are to be different. In addition, it is not clear what protein is encompassed by “exopolysaccharide biosynthesis protein” as there are numerous exopolysaccharide biosynthesis proteins known.
Claim 19 is indefinite because it recites SEQ ID NO:3 and 7. There are two different sequences in the specification that are listed as being SEQ ID NO:3 and 7.
Claim 26 is rendered indefinite by the recitation of the trademark Topo. If a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. Claim 26 is further indefinite because it is not clear what limitations the plasmid names engender.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6-8, 11-12, 19, and 38-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clarke et al (J. Biol. Chem, 293:4666-4679, 2018; IDS filed on 1/29/2024).
The instant claims are drawn to recombinant E coli host cells that comprises a polynucleotide encoding the K. pneumoniae O antigen.
Clarke et al disclose the use of E coli K12 strains that have been modified to contain the polynucleotides required to produce K pneumoniae O antigens (see page 4669). The plasmid used to produce the O antigens encodes all of the proteins recited in claims 7 and 8 and the O antigen produced include serotype O2v1 and O2vs, which are now known as O2a and O2afg (see figures 2-4 and table 2). With regard to claim 19 and the sequences recited therein, the genes disclosed by Clarke et al include the genes recited in the instant claims. Though Clarke et al do not disclose the sequences, claim 19 only requires a fragment of these sequences, which the construct of Clarke et al necessarily contains. The cultures used by Clarke et al were 10 liters, and the O antigen was harvested and purified (see page 4676 and figures 2-7).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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/BRIAN GANGLE/ Primary Examiner, Art Unit 1645