DETAILED ACTION
This application is a Divisional application of US Application Serial No. 17/605,591, now U.S. Patent Serial No. 12,263,211. The instant claims were restricted from the patented claims.
Claim Objections
Claims 1 and 2 are objected to because of the following informalities: in line 3 of claim 1 there is a repeat of “free from”. Claim 2 is included since it depends from claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 112-second 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 3 and 4 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 3 is vague and indefinite because it is unclear what is meant by the term “an article of manufacture.” Is this a kit or something else? The wording: “printed material describing printed material describing an indication for the use of the composition” is vague and confusing. What is the ‘indication’? What is the “use”? The use of the term “an effective amount of” the protein is also unclear because there is no context to what this “article of manufacture” is being used for so it’s unclear what would constitute an effective amount. For example, if the claim is amened to recite a kit, the kit may merely comprise the isolated protein, an adjuvant and instructions or any container. 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 for one to identify what is being claimed. Appropriate clarification and/or correction is required.
Claim 4 is vague and confusing because it is unclear if the cells are naturally occurring cells, e.g., products of nature, or if they are host cells with expression vectors. Additionally, it is unclear what is encompassed by an “antigenic fragment thereof.” The structure of the ‘antigenic fragment’ is not clear and not adequate to sufficiently describe the sequence being described by this language. The use of the phrase “allowing expression of a protein” from the plurality of cells is unclear. There are also no steps for how this is “allowed.” There are also no separation or purification steps. Appropriate clarification and/or correction is required.
Claim 4 recites the limitation "or the antigenic fragment" in line 2. There is insufficient antecedent basis for this limitation in the claim since the line before only recites ‘a protein”. Appropriate clarification and/or correction is required.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 4 is is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Breton et al (US Patent No. 6,610,836).
Breton discloses isolated polypeptide and nucleic acid sequences derived from Klebsiella pneumoniae (abstract). Breton discloses a sequence (SEQ ID NO: 10601) which is 99.8% sequence identity to SEQ ID NO: 2. The instant claim recites “or the antigenic fragment thereof” so the protein disclosed by Breton applies, e.g., given the high sequence similarity it would be antigenic. At paragraph [0039] Breton recites, in another aspect, the invention encompasses: a vector including a nucleic acid which encodes an K. pneumoniae polypeptide or an K. pneumoniae polypeptide variant as described herein; a host cell transfected with the vector; and a method of producing a recombinant K. pneumoniae polypeptide or K. pneumoniae polypeptide variant; including culturing the cell, e.g., in a cell culture medium, and isolating an K. pneumoniae or K. pneumoniae polypeptide variant, e.g., from the cell or from the cell culture medium. Paragraph [0042] recites:
The invention also encompasses recombinant DNA (including DNA cloning and expression vectors) comprising these K. pneumoniae-derived sequences; host cells comprising such DNA, including fungal, bacterial, yeast, plant, insect, and mammalian host cells; and methods for producing expression products comprising RNA and polypeptides encoded by the K. pneumoniae sequences. These methods are carried out by incubating a host cell comprising an K. pneumoniae-derived nucleic acid sequence under conditions in which the sequence is expressed. The host cell may be native or recombinant. The polypeptides can be obtained by (a) harvesting the incubated cells [i.e., plurality] to produce a cell fraction and a medium fraction; and (b) recovering the K. pneumoniae polypeptide from the cell fraction, the medium fraction, or both. The polypeptides can also be made by in vitro translation.
Allowable Subject Matter
Claims 1 and 2 would be allowable if claim 1 is amended to overcome the claim objection set forth in this Office action, e.g., delete the extra “free from” in claim 1.
Claim 3 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Status of claim 4
It is noted that Claim 4 does not require an adjuvant or the full-length polypeptide of SEQ ID NO:2, e.g., it may comprise any antigenic fragment.
Closest prior art
Claims 1- 3 are free of the prior art.
The closest prior art, Breton et al (US 6,610,836), discloses a sequence (SEQ ID NO: 10601) which is 99.8% sequence identity to SEQ ID NO: 2. However, the instant claims require 100% identity. Additionally, Breton discloses well over 10,000 protein and nucleic acid sequences. Despite its disclosure of over 10,000 sequences (none of which is the same as SEQ ID NO:2), presents no results using even one of the thousands of sequences described, nor does Breton include even a single figure demonstrating that any protein described in Breton has any immunological activity. Accordingly, the use of the protein having SEQ ID NO: 2 with an adjuvant
Doyle, S. (UniProt Accession No. A0A2X3GDW1; provided by Applicants) teaches a predicted amino acid sequence with 100% similarity to SEQ ID NO: 2); however, the entry version is dated 9/13/23. The sequence is only described as “protein of uncharacterized function” and the entry version is dated 9/13/23. Accordingly, the function of the protein was not known and there is no indication it has any immunogenic activity. Further, instant claim 1 teaches the protein is in an composition with an adjuvant, wherein the composition is free from Klebsiella proteins other than SEQ ID NO:2, and wherein when the composition is introduced into a female bovine mammal, the composition promotes at least one of: 1) increased milk production relative to milk production by female bovine animals vaccinated with a composition comprising a Klebsiella pneumoniae bacterial extract; 11) reduced severity of mastitis relative to severity of mastitis in female bovine animals vaccinated with a composition comprising a Klebsiella pneumoniae bacterial extract; or a combination of i) or ii).
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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-Thursday from 8:00 AM-6:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gary Nickol, can be reached on (571) 272-0835.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 10/15/25