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 response and amendment to the claims filed 5-18-2026 has been entered into the record.
Status of Claims
Claims 1, 2, 5, 6 and 10-14 are pending. Claims 3, 4, 7-9, and 15-18 have been canceled.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election of Group I in the reply filed on 5-18-2026 is acknowledged. Because applicant 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)).
Information Disclosure Statement
The information disclosure statement filed 6-11-2024 has been considered. An initialed copy is enclosed.
Specification
The title of the invention is not descriptive of the claimed invention. A new title is required that is clearly indicative of the invention to which the claims are directed.
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 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.
Claims 1, 2, 5, 6, and 10-14 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: 1) scope or breadth of the claims; 2) nature of the invention; 3) relative level of skill possessed by one of ordinary skill in the art; 4) state of, or the amount of knowledge in, the prior art; 5) level or degree of predictability, or a lack thereof, in the art; 6) amount of guidance or direction provided by the inventor; 7) presence or absence of working examples; and 8) quantity of experimentation required to make and use the claimed invention based upon the content of the supporting disclosure. When the above factors are weighed, it is the Examiner’s position that one skilled in the art could not practice the invention without undue experimentation.
While all of the factors have been considered, only those deemed necessary to establish a prima facie case are set forth below.
Scope or breadth of the claims
The instant claims are broadly drawn to a K. pneumoniae O1v1 O-antigen polysaccharide which is less than 50%, 40%, 30%, 20%, 10%, 5% or 1% pyruvylated or not capped with a pyruvate group. K. pneumoniae O1v1 O-antigen polysaccharide which is less than 50%, 40%, 30%, 20% 20%, 10%, 5% or 1% pyruvylated lacks enablement in the specification as filed as the specification does not teach how to make such molecules.
Knowledge of the prior art
The prior art does not explicitly teach pyruvylation modifications of the O1v1 O-antigen polysaccharide and how they are positioned on the polysaccharide.
Guidance provided by inventor/working examples
The specification teaches at page 12, lines 6-8, that the applicants determined that the galacan II polysaccharide of serogroup O1, is naturally capped by a terminal pyruvate which substitutes the terminal galactose at positions 3 and 4. The specification also teaches that the effect of the wbbZ deletion in K. pneumomiae wild type strains, including O1v1, were not bound by a monoclonal antibody that recognized only the pyruvylate cap on galactan II (see Example 3, page 68). Additionally, the applicants determined that the deletion of wbbZ (i.e. Z-) provided for a non-pyruvylated form of the O1v1 polysaccharide (see Example 5, page 71, lines 11-12). Thus, the specification provides for 100% pyruvulation or 0% pyruvylated form of O1v1 polysaccharide. No other pyruvylated positions on the O-antigen have been provided in the specification.
The specification provides no guidance on how to achieve any intermediate % pyruvulation that is less that 50% but greater than 0% which is encompassed by the language “O1v1 O-antigen polysaccharide which is less than 50%, 40%, 30%, 20% or 10% pyruvylated” or less than 5% or 1%. It is unclear how to make such variant polysaccharides by means of the methods disclosed in the specification as filed as only two sites of pyruvylation are disclosed. The art of record and the prior art does not teach how and where to make these other pyruvylated polysaccharides. The specification and the art does not teach any other pyruvylation mechanisms or sites on the O1v1 polysaccharide. As such, the specification as filed, does not teach O1v1 polysaccharides having these levels of pyruvylation, nor how to make. The specification cannot rely upon the art to fill the missing description and methods to arrive at an invention which is not described and cannot be made by the means and methods of the specification.
Level or degree of predictability
The degree of predictability is low as the art does not teach pyruvylation of the K. pneumoniae O-antigen polysaccharide. The ability to make the claimed polysaccharides is unknown and untested. The skilled artisan would have to discover potential different genes which pryuvylate different positions on the O1v1 polysaccharide of the O-antigen, and then discover how to modify them to potentially achieve a polysaccharide falling within the claimed scope. The specification does not set forth the chemical synthesis thereof. In cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictably of factors involved." (In re Fisher 166 USPQ 18 (CCPA)).
Quantity of experimentation
The courts have held that "... whenever there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of the invention in order to constitute adequate enablement." Genetech Inc. v. Novo Nordisk A/S 42USPQ2d 1001. “A patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” (Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997)).
In light of the foregoing factors, the evidence as a whole suggests that the specification, in light of the level of knowledge in the art, does not enable one of ordinary skill to make or use the invention over the full scope of the instant claims without undue experimentation. Consequently, the claims are prima facie non-enabled.
Claims 2, dependent claims 5, 6 and claim 14 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.
As to claims 2 and 14, the claim defines ‘”n” as having two different values. The same subscript cannot have two different meanings. It is suggest that the D-galatan I be renamed as “m” to properly distinguish the features of the polysaccharide. Dependent claims 5 and 6 are likewise rejected as they do not resolve the issue.
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 and 2 are rejected under 35 U.S.C. 102(a)1 as being anticipated by Hsich et al (Frontiers in Microbiology, Vol. 5, Article 608, pages 1-13, 2014; of record).
Hsich et al teach construction of mutants in K. pneumoniae O1-1 which is inherently the D-galactan II-D-Dalactan I -GlcNac polysaccharide structure of the claims. Hsich teach an in-frame deletion mutant of wbbZ and a non-polar deletion mutant of wbbZ that retained the upstream end of the wbbZ open reading frame and examined the production of capsular polysaccharide and lipopolysaccharide in these mutants (see page 5, column 1, second paragraph). Hsich et al teach that the non-polar deletion mutant of K. pneumoniae produced high-molecular weight polysaccharide (see page 5, column 2, first paragraph and Figure 3B). The non-polar deletion mutant of wbbZ in K. pneumoniae O1-1 inherently produces the non-pyruvylated form of the O1-1 polysaccharide and as such, the claims are anticipated.
Free of the Prior Art
The immunogenic compositions comprising bioconjugates of unpyruvylated Klebsiella penumoniae O1v1 O-antigen polysaccharide conjugated to a carrier protein including detoxified exotoxin A of Pseudomonas aeruginosa (EPA) carrier protein is free of the prior art and allowable over the prior art.
Hsich et al teach that D-Gal II is the immunodominant antigen of O1v1 and immunization against D-Gal II provides for protection against infection (see page 12, column 2, last paragraph). In the absence of some motivation or reason to select and conjugate the O1v1 O-antigen polysaccharide of the non-polar deletion mutant of wbbZ of Hsich et al which is inherently not-pyruvylated, the unpyruvylated conjugates are free of the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Patricia Duffy whose telephone number is (571)272-0855. The examiner can normally be reached 8:00 am - 4 pm.
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/Patricia Duffy/Primary Examiner, Art Unit 1645
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