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 .
Election/Restrictions
Applicant’s election of Group I, claims 34-45 in the reply filed on 9/25/25 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)).
Claims 46-53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/25/25.
Priority
Application claims priority to 63/073,518 provisional application with an effective filing date of 9/2/20. Claims of the instant application are supported by the provisional application and thus have a priority date of 9/2/20.
Information Disclosure Statement
The IDS filed on 3/20/23has been fully considered except where references have been lined through.
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 34-45 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 Vibrio natriegens, does not reasonably provide enablement for any genetically modified non-pathogenic bacterium. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to carry out the invention commensurate in scope with these claims.
Whether a disclosure satisfies the enablement requirement is assessed with respect to the factors set forth in In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988); MPEP 2164.01 (a). These factors include: breadth of the claims, nature of the invention, state of the prior art, level of one of ordinary skill, level of predictability in the art, amount of direction provided by the inventor, existence of working examples and quantity of experimentation needed to make or use the invention.
All of the Wands factors have been considered with respect to the instant claims, and the most relevant factors are discussed in detail below.
Breadth of the claims/Nature of the invention
The elected species of the invention currently under examination is directed a genetically modified non-pathogenic bacterium. Thus, carrying out the invention requires a genetically modified non-pathogenic bacterium.
State of the prior art/Level of predictability
As evidenced by Dykhuizen there could be up to 1 billion species of bacteria (introduction). Dykhuizen teaches that less than 1% of bacteria can be cultured (introduction). Thus, carrying out the invention requires the isolation of vast numbers of bacterial species more than 99% of which cannot be currently cultured and figuring out how to genetically engineer each of the bacterial strains.
Amount of direction provided/Existence of working examples
The instant specification discloses only Vibrio natriegens. The specification does not provide any additional information, nor any structure-function relationship or other guidance that would allow one skilled in the art to determine such information.
Quantity of experimentation needed to make or use the invention
The claimed invention requires knowledge of the huge genus of genetically modified non-pathogenic bacterium. Such information is not available in the prior art. As such, one of ordinary skill in the art would be required to undertake undue experimentation to carry out the claimed 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.
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 34-45 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.
A claim may be rendered indefinite when a limitation of the claim is defined by reference to an object and the relationship between the limitation and the object is not sufficiently defined. That is, where the elements of a claim have two or more plausible constructions such that the examiner cannot readily ascertain positional relationship of the elements, the claim may be rendered indefinite. See MPEP 2173.05(b).
Whether or not a bacterium is pathogenic or not depends on the host. As evidenced by Hinnebusch, Y. pestis is carried by insect hosts (non-pathogenic) which can then cause human disease (pathogenic) (abstract and whole document). Therefore, the definition of “non-pathogenic” is indefinite as that relationship is host dependent and no hosts are required by the claims.
Regarding claim 34, the claim requires “at least one effector-immunity pair, delivery of which exerts the antibacterial activity”. It is unclear from this language how delivery of an effector and its cognate immunity factor would lead to antibacterial activity as the effector activity would thereby be canceled by the immunity factor and would therefore not result in antibacterial activity. For examination purposes, delivery of an effector resulting in the antibacterial activity will be considered to meet this claim limitation.
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.
Claims 34-45 are rejected under 35 U.S.C. 103 as being unpatentable over Levy (US20210101931A1), and Ray ("Type VI secretion system MIX‐effectors carry both antibacterial and anti‐eukaryotic activities." EMBO reports 18.11 (2017): 1978-1990.) While Levy was published after the filing date of instant application, it claims priority to 11/3/17 and therefore is valid prior art under 35 U.S.C. 102(a)(2). While Ray shares a common inventor with instant application, it was published more than 1 year before the effective filing date of instant application and therefore is valid prior art under 35 U.S.C. 120(a)(1).
Regarding claim 34, Levy teaches methods and compositions for inhibiting growth of bacteria (antibacterial activity) (title). Levy teaches the host cell can comprise a type 6 secretion (T6SS) system (genetically engineered, gene cluster encoding an antibacterial protein delivery platform for producing antibacterial activity) (abstract). Levy teaches non-pathogenic bacteria can be the host (abstract). Levy teaches the antibacterial protein to be administered is a Hyde1 protein ([0025]). Levy teaches the proteins are injected into the pathogenic bacteria, killing it (effector-immunity pair exerting antibacterial activity) ([0025]). Levy teaches that different vectors can encode different operons (signal inducible positive regulation system on different genetic loci than the effector protein) ([0060]).
Levy does not explicitly teach the signal-inducible positive regulation system. Ray studies type VI secretion system with both antibacterial and anti-eukaryotic activities (title). Ray teaches that T6SS are contact dependent (signal inducible positive regulation system) (p1979 “introduction”). Ray teaches that the T6SS and effector proteins can be found in different genetic loci (figure 1). Ray teaches that the T6SS and their associated effector proteins are a lucrative candidate to use as a platform for biocontrol against pathogens (p1985 “Vpr uses the T6SS1 MIX-effector Vpr01570 to manipulate actin in macrophages”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the T6SS of Ray in the non-pathogenic antimicrobial microbe of Levy. One of ordinary skill in the art would be motivated to do so because Ray teaches their T6SS and effectors are a lucrative candidate to use as a platform for biocontrol. There would be a reasonable expectation of success as both Levy and Ray are in the same field of endeavor of T6SS.
Regarding claims 35, Levy teaches gene expression can be controlled via IPTG (activator is a signal receptor/regulator configured to associate with at least one signal activated promoter, upon sensing an activating signal) (0134]).
Regarding claim 36, Ray teaches that T6SS are contact dependent (activating signal is an external signal exerted by a pathogen) (p1979 “introduction”).
Regarding claim 37, Ray teaches that the T6SS gene cluster comprises transcriptional regulators (promoters) (fig 1 and p1979 “Vpr encodes three T6SSs and seven MIX-effectors”).
Regarding claim 38, Regarding claim 44, Levy teaches that a plurality of vectors can be used in their invention (different chromosomes) ([0060]).
Regarding claim 39, Ray teaches that the T6SS gene cluster comprises effector/immunity pairs from the same strain (fig 1 and p1979 “Vpr encodes three T6SSs and seven MIX-effectors”).
Regarding claim 40, Levy teaches the gene cluster can be found in pathogenic bacteria ([0045 and fig 6C).
Regarding claim 41, Levy teaches that the T6SS can be knocked out (devoid of an endogenous T6SS) ([0048]).
Regarding claim 42, Levy teaches expression vectors (plasmids) can be used ([0060]). Ray teaches plasmids can be used (p1986 “plasmid construction”).
Regarding claim 43, Levy teaches that the Hyde/Jeckle proteins (effector/immunity) are located at numerous locations in the genome (chromosome) ([0104-0105]).
Regarding claim 44, Levy teaches that single or a plurality of vectors can be used (different chromosomes) ([0060]).
Regarding claim 45, Levy teaches the bacteria can be co-cultured (example 1).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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/TREVOR KANE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
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