DETAILED ACTION
Formal Matters
Claims 1-50 are cancelled. Claims 51-70 are pending and under examination.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a national stage entry of PCT/IL2023/050716 filed on 07/10/2023, which claims priority to 63/499,998 filed on 5/4/2023 and 63/359,905 filed on 7/11/2022.
Information Disclosure Statements
The information disclosure statement (IDS) filed on 07/21/2025 has been considered by the examiner.
Claim Objections
Claim 1 is objected to for “de-wetted” which appears to be a misspelling of “re-wetted”.
Claims 1 and 68 are objected to for using an “O” instead of “0” in the number “1O” regarding PFU, which is supposed to be the number “10”.
Claim 62 is objected to for missing a comma “,” between “biofilm” and “a plant” in line 2 of the claim.
Claim 63 is objected to for use of “P” without first defining it in the claim as what the full name of P is. The specification example 1 (an on page 9) provides the P is “Pectobacterium” and this can be included with the first recitation of P as “P (Pectobacterium)”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) – Written Description
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.
Claim 52 is 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. Claim 52 contains the word “derivatives” which is defined in the specification on page 22 to include “salts, amides, esters, enol ethers, enol esters, acetals, ketals, orthoesters, hemiacetals, hemiketals, acids, bases, solvates, hydrates or prodrugs of hydrocolloids” lacks written description for its encompassing of “amides”, esters”, “enol ethers”, “acetals”, “ketals”, “orthoesters”, hemiacetals”, “hemiketals”, “prodrugs”. The specification does not provide guidance on making various prodrugs with the listed polysaccharide hydrocolloids and which active agents would be used along with the functional structures that would allow them to act as prodrugs. As the genus of prodrugs varies with the different types of active agents as well as the different types of linking groups that would allow activation of the active agent upon various kinds of stimuli, it would need such description of a representative number of functional structures that would be considered to satisfy the genus of prodrug. This applies to the other groups specifically listed above as they imply a connection to other different compound structures through these linkages. Without description of what structures would constitute all such compounds that are considered “amides”, esters”, “enol ethers”, “acetals”, “ketals”, “orthoesters”, hemiacetals”, and “hemiketals”, applicant has not show sufficient ownership of these genre. Applicant would need to sufficiently describe how all such compounds would be made to define this genus in a manner that provides for the full genus with intended attachment structures or would need to provide a representative number of species of each that would encompass these genre of compounds. Based on the art, applicant would have sufficient description for “salts, “acids”, “bases”, “solvates” and “hydrates” of those compounds listed in this group. For example, alginate has an acid group that can be acidic and chitosan has a basic group that can be basic. Such compounds are also know to exist as salts (e.g. sodium alginate or chitosan lactate). Solvates or hydrates (a specific solvate involving water) are known to exists for listed compounds in this group. Thus, applicant could use these more described terms (“salts, “acids”, “bases”, “solvates” and “hydrates” thereof” in place of derivatives since “derivatives” covers matter lacking sufficient written description.
Claim Rejections - 35 USC § 112(b)
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 56, 57, 58, 59, 61, 64 and 67 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.
Claims 56 and 57 are recites the limitation "the dry system" in the claim where prior recitations provide for dried-gel system. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend the claims to say “of the dried-gel system”.
Claims 58 and 59 are rejected as being dependent on an indefinite claim.
Claim 61 is indefinite for “suspended release” as it is unclear what “suspended release” is referring to. It is unclear if applicant means to say “sustained release” or if they have a different intention with “suspended release” as it does not appear to be standard terminology in the art. For the purpose of compact prosecution, the term will be read as “sustained release”.
Claim 64 is indefinite for the use of the various parentheticals in the claim as many of the parentheticals provide for a larger genus or subgenus or a more limited species than what is on the outside of the parenthetical. Some examples (not exhaustive) are “lettuce (head and leaf)”, “broad bean (fava)”, “savory (summer and winter)”, “dill (seed)”, “Marjoram (including oregano)” and “chayote (fruit)”. It is unclear if what is in the parentheses should be construed as part of the claim or just meant as an example of items that might apply. Applicant may delete all the parenthetical recitations or if applicant means “chayote (fruit)” to be “chayote fruit” or “dill (seed)” to be “dill seed”, they may write it in such a manner.
Claim 67 is indefinite for the recitation of “ship maintenance” as this is not an item, but is an act of performing ship maintenance. It is unclear if the claim should be limited to only items that are things or if items might also encompass acts of doing something such as ship maintenance. If applicant means to say “ship maintenance equipment”, then applicant might write it in this manner.
Claim Rejections - 35 USC § 103
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 51-52, 54-55, 62, 66, 67, and 68 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over CN104357354B (with Google English translation).
Note the recitation of “when the system is in the dried-gel form” is only an occurrence when in the dried-gel form and the claim still allows for wet gel or de-wetted gel.
CN ‘354 teaches the production method of a kind of bacteriophagic Bdellovibrio microbial ecological agent, comprise the steps: 1) preparation of host bacteria suspension；2) preparation of slow-releasing granules；3) preparation of culture fluid；4) preparation of seed；5) preparation of bdellovibrio bacteriovorus preparation. The present invention adopts the slow release method of Host Strains, overcomes the current defect that the phage bdellovibrio preparation shelf-life is short, bacterial content is unstable, improves the phage bdellovibrio preparation effect to disease control of aquatic animal Yu water quality improvement (abstract). CN ‘354 teaches “The gel that the preparation of slow-releasing granules described in step 2 uses can also be 1%-6% alginate, and cross-linking agent is 1%-8%CaCl2；The gel that the preparation of slow-releasing granules described in step 2 uses can also is that 2%～10% gelatin and 1%-6% alginate mixed liquor, and cross-linking agent is 1%-8%CaCl2” (English translation of CN ‘354). CN ‘354 teaches 10^7 to 10^9 pfu/ml of the bdellovibrio bacteriovorus preparation used (English translation). Embodiment 1 teaches 10^8 preparation. Embodiment 3 teaches 3% sodium alginate in the preparation as well as 7% gelatin. Embodiment 3 also has 10^8 pfu/ml of bdellovibrio bacteriovorus preparation. Embodiment 4 provides for using the preparation of concentration 10^8 pfu/ml to add to infected water. CN ‘354 provides “Results of the test shows: after using bdellovibrio bacteriovorus preparation of the present invention, vibrio sum in Chi Shui and prawn liver is decreased obviously, pond prawn is without the sick death of outburst, and feeding volume is normal, and therefore bdellovibrio bacteriovorus preparation of the present invention prevents the effect of bacterial disease better in prawn culturing” (last paragraph of English translation). Thus, the preparation is cable of reducing bacterial load in the prawn culturing system (an aquatic system, under table 2 provides for prawn culturing pond). Note that embodiment 3 provides for the mixing of the alginate, gelatin and CaCl to prepare slow releasing granules and the mixing with bdellovibrio bacteriovorus suspension.
CN ‘354 does not indicate the granules are beads.
One of ordinary skill in the art before the time of filing would see beads/microspheres as forms within the genus of granules and therefore would have a reasonable expectation of success in producing the bead/rounded granule forms that would also be useful for its purpose of stably storing and delivering the Bdellovibrio bacteriovorus to the site of delivery including the aquaculture system for prawns of CN ‘354 for effective treatment of a pathogenic microbe.
Claims 51-55, 57-58, and 61-70 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Saenz-Santos et al (Coatings, May 2021, volume 11, pages 1-14), Youdkes et al (ASM Journals, Applied and Environmental Microbiology, March 2020, volume 86) and Nussinovitch US 7422737.
Saenz teaches polymeric matrices as carriers of a living Bdellovibrio bacteriovorus with antimicrobial potentials against pathogens (abstract and section 2.1-2.3). Saenz teaches a mixture of collagen/sodium alginate/sorbitol, collagen/sodium alginate/glycerol and tapioca starch/sodium alginate/glycerol as options for polymer matrices (abstract). Sodium alginate is a polysaccharide. Collagen is a protein. Saenz provides for PFU/g of 2.8X10^7, 2.2X10^7 and 3.0X10^8 (table 1). Section 2.3.2 provides for dry films that can be rehydrated. Saenz teaches “The selection and development of a suitable encapsulating agent are important for the viability of B. bacteriovorus” (Introduction). Saenz teaches “B. bacteriovorus is a deltaproteobacterium that preys especially upon other Gram-negative bacteria. B. bacteriovorus invade the periplasm of their prey, forming a structure called a bdelloplast [5]. Within the bdelloplast, B. bacteriovorus grows, multiplies, and finally lyses its prey, releasing progenies that can continue the attack [6].” (Introduction). Saenz teaches entrapping the B bacteriovorus in biopolymeric films (section 2.3).
Saenz does not teach the structure of beads. Saenz does not teach limitations of claim 53, 54, 57, 58, and 61-70.
Youdkes teaches that BALO (Bdellovibrio and like Organisms) can control potato soft rot caused by Pectobacterium spp and Dickeya spp. (abstract and results).
Nussinovitch teaches cellular solid carriers comprising viable microorganisms capable of controlling plant pathogens and that “The cellular solid carriers are formed from water-soluble hydrocolloid beads dried under conditions which preserve their porosity, thereby allowing efficient release of microorganisms or diffusion of products derived from the microorganisms from the beads to the surrounding environment” (abstract). Nussinovitch teaches “Solid porous cellular hydrocolloid carriers comprising porous freeze-dried hydrocolloid beads that include viable microorganisms entrapped therein, wherein the hydrocolloid is an alginate, agarose, Low Methoxy Pectin (LMP), polyvinyl alcohol (PVA), Carrageenan or xanthan plus locust bean gum (LBG); and wherein the freeze-dried beads have diameters ranging from 50 microns to 500 microns; have a residual moisture of no more than 12%, and include a cryoprotectant comprising glycerol in an amount of 10 to 50% by weight of the hydrocolloid, wherein a not less than 50% to 95% of the microorganisms are viable both during freeze drying and after 12 to 36 months of storage as a dried solid at temperatures at or below minus 18° C” (claim 1 of Nussinovitch). Nussinovitch teaches microorganisms are bacteria or fungi capable of controlling plant pathogens (claim 6 of Nussinovitch). Nussinovitch teaches bacteria including “Pantoae agglomerans, Serratia marcescens, Bacillus Spp., Enterobacter Spp., Azotobacter, Azospirillum and Pseudomonas” (claim 9 of Nussinovitch). Nussinovitch teaches protecting plants/crops like vegetables, oats, barley, alfalfa, sugar beets, poplars and corn (column 7). Nussinovitch teaches potatoes, tomatoes and turf grasses (column 7). Nussinovitch teaches using the beads in soil (column 7). Nussinovitch teaches 10^3 to 10^10 colony forming units of bacteria or spores per bead (column 8, lines 23-26). Nussinovitch teaches alginate concentrations of 0.5 to 3 wt% (column 8, lines 33-38). Nussinovitch teaches metal cations like calcium, zinc, copper and others to cause gelation of sodium alginate and concentrations of calcium of 1 to 15 w/v% (column 8, lines 38-48). Nussinovitch teaches “a cryoprotectant comprising glycerol in an amount of 10 to 50% by weight of the hydrocolloid to the hydrocolloid solution and microorganisms to form a mixture” (claim 15 of Nussinovitch). Nussinovitch teaches spraying or tickle drip irrigation into soil or spraying on crops as well as seed treatment (column 7 and top of column 8). Nussinovitch teaches delayed and sustained release of the microorganisms (column 9). Nussinovitch teaches “The methods of the invention comprise providing natural means of biologically controlling a plant disease in a susceptible crop. According to these methods, an effective growth-inhibiting amount of suppressive biological control microorganisms entrapped within a cellular solid carrier of the invention are applied to the susceptible crop to inhibit the growth of one or more species and/or strains of a pathogenic plant microorganism. The application of the suppressive biological control microorganisms can also provide for growth enhancement either directly or indirectly” (column 6). Nussinovitch teaches “Strain IC1270 (˜1011 cells/ml) or T-203 (˜109 spores/ml) were then added at a 1:9 volumetric ratio to the different sterile alginate solutions. Those final mixtures were dripped into a 1% (w/w) sterile solution of calcium chloride and stirred for 30 min (the volumetric ratio between the alginate mixture and the calcium chloride solution was 1:50). A spontaneous cross-linking reaction produced spherical beads with a diameter of 2.9 to 3.6 mm, containing either ˜10^7 CFU/bead (fungi) or ˜10^9 cells/bead (bacteria). The beads were removed from the calcium chloride solution and washed twice with sterile distilled water through a strainer (funnel) to remove excess ions from their surface. Then, the beads were frozen at −80° C. for 1 h before freeze-drying, which was carried out at −50° C. at a pressure of 1.1 Pa” (columns 9 and 10). In columns 16 and 17, it is mentioned that beads are dried (also example 3).
One of ordinary skill in the art before the time of filing would have utilized teachings of Youdkes and Nussinovitch to modify the composition of Saenz (alginate (polysaccharide) material containing Bdellovibrio) as Youdkes provides a motivation to utilize Bdellovibrio and like organisms to treat plant pathogens and Nussinovitch teaches forms of encapsulated microbes that can be used for treating crops and soil. One of ordinary skill in the art would be motivated to use other forms of polymeric encapsulation (beads of Nussinovitch) to deliver the Bdellovibrio to sites of pathogenic bacteria including crops, soil near crops and likely to any area needing reduction or elimination of pathogenic microbes they are recognized as effective for. Thus, there was a reasonable expectation of success of combining the teachings of the prior art to provide effective delivery polysaccharide bead/particle systems for Bdellivibrio and Like Organisms (recognized as BALOs) in order to treat crops, plant parts, soils and other items to reduce or eliminate pathogenic microbes they are useful for reducing or eliminating.
Claims 56, 59 and 60 in addition to Claims 51-55, 57-58, and 61-70 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Saenz-Santos et al (Coatings, May 2021, volume 11, pages 1-14), Youdkes et al (ASM Journals, Applied and Environmental Microbiology, March 2020, volume 86), Nussinovitch US 7422737 and Chavarri et al (Probiotics, October 2012, DOI: 10.5772/50046).
Saenz, Youdkes and Nussinovitch teach the claims as provided above. Nussinovitch teaches carrageenans, generally.
Saenz, Youdkes and Nussinovitch do not teach kappa-carrageenan, gelatin or use of trehalose in making the beads.
Chavarri teaches encapsulating probiotic living cells and provides for common techniques for encapsulation (section 3). Chavarri mentions encapsulation for creating a micro-environment where bacteria can survive during processing and storage and released at appropriate sites (section 3, first paragraph). Chavarri teaches adding trehalose to improve probiotic survival (protect the probiotic) (section 3.1.1, also section 3.1.3 last paragraph). Chavarri teaches K-carrageenan beads for encapsulating probiotic cells and keep bacteria in a viable state (section 3.2.2- Carrageenan). Chavarri teaches gelatin for being useful to produce beads and can be used with anionic polysaccharides while mentioning the hydrocolloids (section 3.2.2 – Gelatin). Section 3.1.1 provides hydrocolloid such as gelatin. Chavarri teaches gelatin gels depend on gelatin grade and concentration (section 3.2.2).
One of ordinary skill in the art before the time of filing would have utilized K-carrageenan and gelatin as other appropriate agents to help encapsulate microorganisms by the teachings of Chavarri, which notes their common usage and ability to form encapsulates of microorganisms, and use trehalose as a further protectant for the microorganisms when making encapsulated BALOs by the combined teachings of Saenz, Youdkes and Nussinovitch as BALOs are also microorganisms that can be encapsulated for use, which are desired to be kept viable until release upon delivery for their action to help destroy pathogens. Thus, there was a reasonable expectation of success in combining the teachings of Chavarri with teachings of Saenz, Youdkes and Nussinovitch to arrive at applicant’s claimed invention of these claims by using common techniques and agents of the prior art for the purpose of encapsulating live microbes. Chavarri also recognizes releasing the microbes at desired sites, and thus, there is motivation to adjust the encapsulated product for desired release profiles. Amounts of gelatin (a recognized hydrocolloid) would be seen as routinely optimizable for the formation of the gel (see MPEP 2144.05).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached on M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/
Examiner, Art Unit 1613
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