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 claim amendment is received.
Claims 2, 4, 6, 7, are canceled by Applicant.
Claims 1, 3, 5, 8, 9, 11, 12, 16, 18, 19, 22 24, 25, 41, 42, 44, 48, 49, 52, 54 and 55 are pending and are being examined.
Objection(s):
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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.
Claim 3 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The invention appears to employ a specific strains: Ligilactobacillus salivarius UO.C 109, Ligilactobacillus saerimneri UO.C 121 and Ligilactobacillus salivarius UO.C249.
It is not clear if the written description is sufficiently repeatable to avoid the need for a deposit.
Further it is unclear if the starting materials were readily available to the public at the time of invention.
It appears that a deposit was made in this application as filed as noted in applicant’s specification (pages 12 and 18-19). However, it is not clear if the deposit meets all of the criteria set forth in 37 CFR 1.801-1.809. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C § 112, first paragraph, in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
1. Identifies declarant.
2. States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
3. States that the deposited material has been accorded a specific (recited) accession number.
4. States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
5. States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
6. States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
7. That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g. see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
Copy of deposit receipt is/are required.
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 5 and 16 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 5, recites the limitation "a second active ingredient" in claim 1. There is insufficient antecedent basis for this limitation in the claim. Because claim 1 does not recite an active ingredient or a first active ingredient.
Suggestion to obviate the rejection: provide antecedent basis.
In claim 16, the recitation “effective amount” is indefinite because it is not exactly clear what amount applicant is trying to encompass by this recitation. In addition, there is no special definition in the specification for the effective amount. As such the scope of the claim is not clearly set forth.
Suggestion to obviate the rejection: delete the phrase.
Claim Rejections - 35 USC § 101
(Law of Nature or Natural Product)
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 5, 8 and 25 are rejected under 35 U.S.C. 101 because;
The claimed invention is directed to a judicial exception, i.e., a natural product without significantly more. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
According to Section I of the 2019 Revised Patent Subject Matter Eligibility Guidance, “the judicial exceptions are for subject matter that has been identified as the ‘‘basic tools of scientific and technological work,’’ which includes ‘‘abstract ideas’’ such as mathematical concepts, certain methods of organizing human activity, and mental processes; as well as laws of nature and natural phenomena”, and “the USPTO has set forth a revised procedure, rooted in Supreme Court caselaw, to determine whether a claim is ‘‘directed to’’ a judicial exception under the first step of the Alice/Mayo test (USPTO Step 2A).” (Also see “2019 Revised Patent Subject Matter Eligibility Guidance, Federal Register / Vol. 84, No. 4 / Monday, January 7, 2019 / Notices, p. 50-57”).
Step 2A asks: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? In the context of the flowchart in MPEP § 2106, subsection III, Step 2A determines whether:
• The claim as a whole is not directed to a judicial exception (Step 2A: NO) and thus is eligible at Pathway B, thereby concluding the eligibility analysis;
or
• The claim as a whole is directed to a judicial exception (Step 2A: YES) and thus requires further analysis at Step 2B to determine if the claim as a whole amounts to significantly more than the exception itself.
Step 2A is a two-prong inquiry, in which examiners determine in Prong One whether a claim recites a judicial exception, and if so, then determine in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
Claims 1, 3, 5, 8 and 25 are drawn to composition comprising Ligilactobacillus sp. and/or bacterial extracellular vesicle isolated from Ligilactobacillus sp., wherein the Ligilactobacillus sp. is selected from the group consisting of Ligilactobacillus salivarius, and Ligilactobacillus saerimneri or combination thereof.
The broadest reasonable interpretation of instant claim 1 includes bacteria of Ligilactobacillus sp (naturally occurring, microbiota, human vagina, feces, etc.) Ligilactobacillus salivarius formerly known as Lactobacillus salivarius (See for example, p. 57 Introduction and p. 59, “Table 1.” “Strain and origin” of Guerrero Sanchez et al.), and Ligilactobacillus saerimneri (See for example, p. 1367 left-hand column 3rd and 4th paragraphs below Figure 2 of Pedersen et al.), also and/or extracellular vesicles (are naturally occurring) (See for example, p. 317 right-hand column 2nd paragraph of Bose et al.).
Thus, the claims as a whole are directed to a judicial exception.
In addition, there is no evidence of any markedly different functional characteristic other than the inherent natural functions or properties of the claimed Ligilactobacillus species. Therefore, claims as a whole do not amount to significantly more than the exception itself (Answer to Step 2B: No).
As indicated above, step 2A is a two-prong inquiry, in which examiners determine in Prong One whether a claim recites a judicial exception, and if so, then determine in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
In this case, there is no additional elements recited in the claims, and the phrase “probiotic microorganism and/or a prebiotic and/or postbiotic” (in claim 5) and formulated for oral administration or topical administration (claim 8), are specified at a high level of generality, and thus are not considered ‘significantly more’ than the judicial exception.
Therefore, claims 1, 3, 5, 8 and 25 do not integrate the judicial exception into a practical application of that exception (Answer to Step 2A Prong Two: No).
In addition, depositing and obtaining an accession/registration number (claim 2) do not consider to improve the judicial exception or do not use the judicial exception in a particular technological environment such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
In Funk Brothers the Supreme court concluded that naturally-occurring bacteria, isolated from their natural surroundings, was not patent eligible: “[t]he qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of the knowledge of all men…manifestations of laws of nature, free to all…and reserved exclusively to none…” the qualities of the bacteria being “.. the work of nature…unaltered by the hand of man.”.
Therefore, the subject matter of claims 1, 3, 5, 8 and 25 as a whole is not directed to patent eligible subject matter.
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, 5, 8, 9, 11, 12, 16, 18, 19, 22, 24, 41, 42, 48, 49, 52 54 and 55 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Guerrero Sanchez et al. (Appl Microbiol Biotechnol. 2022 Jan;106(1):57-80. Epub 2021 Dec 10).
Regarding claim 1, Guerrero Sanchez et al. disclose a composition for preventing Gram-negative bacteria growth comprising Ligilactobacillus sp. and/or bacterial extracellular vesicle isolated from Ligilactobacillus sp., wherein the Ligilactobacillus sp. is selected from the group consisting of Ligilactobacillus salivarius, and Ligilactobacillus saerimneri or combination thereof (tablets, capsules, bacterial suspensions, comprising Ligilactobacillus sp., Ligilactobacillus salivarius) (See for example, p. 58, p.59 Table 1 -Continued on p. 60-62, “strains” and “mode of administration”, and p. 62 left-hand column paragraph below Table 1).
Regarding claim 5, Guerrero Sanchez et al. disclose the composition further comprising a second active ingredient, wherein the second active ingredient is a probiotic microorganism and/or a prebiotic and/or postbiotic.
Regarding claim 8, Guerrero Sanchez et al. disclose the composition is formulated for oral administration or topical administration.
Regarding claim 9, Guerrero Sanchez et al. disclose the composition is formulated as a food additive, optionally wherein the food additive is an animal feed additive.
Regarding claim 11, Guerrero Sanchez et al. disclose the animal feed additive is a livestock feed additive or aquaculture food additive (bacterial suspension for administration/application in bacterial infections in pigs) (See for example, p. 61 table 1 first row).
Regarding claim 12, Guerrero Sanchez et al. disclose the livestock feed additive is a cattle feed additive, equine feed additive, porcine feed additive or poultry feed additive (bacterial suspension for administration/application in bacterial infections in pigs) (See for example, p. 61 table 1 first row).
Regarding claim 16, Guerrero Sanchez et al. disclose a method of treating and/or preventing food poisoning and/or improving intestinal health and/or reducing bacterial pathogen load in a subject, the method comprising administering an effective amount of the composition of claim 1 (administration/application of bacterial suspension for bacterial infections in pigs, and L. salivarius preventing Salmonella enteritidis colonization in chicken) (See for example, p. 61 table 1 first row, and p. 62 left-hand column 1st paragraph below Table 1).
Regarding claim 18, Guerrero Sanchez et al. disclose the subject is a mammal, a fish, a bird, reptile or amphibian (pigs) (See for example, p. 61 table 1 first row).
Regarding claim 19, Guerrero Sanchez et al. disclose the mammal is a human or domesticated animal; the bird is a poultry; and the fish is an aquaculture fish species (administration/application in bacterial infections in pigs) (See for example, p. 61 table 1 first row).
Regarding claim 22, Guerrero Sanchez et al. disclose a food product or animal feed comprising the composition of claim 1 (incorporated into food matrix) (See for example, p. 63 left-hand column 1st paragraph below figure 1).
Regarding claim 24, Guerrero Sanchez et al. disclose livestock feed or aquiculture feed (bacterial suspension administered to pigs and piglets) (See for example, p. 61 Table 1 first row, and p. 62 left-hand column 1st paragraph below Table 1).
Regarding claim 41, Guerrero Sanchez et al. disclose the bird is a poultry (in chicken) (p. 62 left-hand column 1st paragraph below Table 1).
Regarding claim 42, Guerrero Sanchez et al. disclose the composition is administered orally (incorporated into food matrix) (See for example, p. 63 left-hand column 1st paragraph below figure 1).
Regarding claim 48, Guerrero Sanchez et al. disclose the domesticated animal is livestock pigs and piglets) (See for example, p. 61 Table 1 first row, and p. 62 left-hand column 1st paragraph below Table 1).
Regarding claim 49, Guerrero Sanchez et al. disclose the composition is administered orally (incorporated into food matrix) (See for example, p. 63 left-hand column 1st paragraph below figure 1).
Guerrero Sanchez et al. therefore anticipate the claimed compositions and method of treating and/or preventing food poisoning and/or improving intestinal health and/or reducing bacterial pathogen load in a subject.
Claims 1, 5, 8, 9, 11, 12, 16, 18, 19, 22, 24, 25, 41, 42, 48, 49, 52 54 and 55 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Guerrero Sanchez et al. (Appl Microbiol Biotechnol. 2022 Jan;106(1):57-80. Epub 2021 Dec 10), as evidenced by Croatti et al. (Microbial Cell Factories, Nov. 2022, 21:237, which is cited in IDS filed on 12/23/2024).
The disclosure of Guerrero Sanchez et al. with respect to claims 1, 5, 8, 9, 11, 12, 16, 18, 19, 22, 24, 41, 42, 48, 49, 52 54 and 55 were discussed above.
Regarding claim 25, the bacterial extracellular vesicles, although Guerrero Sanchez et al. do not explicitly disclose extracellular vesicles, however Croatti et al. teach Lactobacillus spp. produce extracellular vesicles (See for example, p. 2 left-hand column 1st and second paragraphs). As such, the claimed bacterial extracellular vesicles are inherently present in the composition disclose by Guerrero Sanchez et al.
Guerrero Sanchez et al. therefore anticipate the claimed compositions and method of treating and/or preventing food poisoning and/or improving intestinal health and/or reducing bacterial pathogen load in a subject.
Claims 1, 52, 54 and 55 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Wang et al. (LWT, Food Science and Technology, , 2021, Volume 137 110419, p. 1-8).
Regarding claim 1, Wang et al. disclose a composition for preventing Gram-negative bacteria growth comprising Ligilactobacillus sp. and/or bacterial extracellular vesicle isolated from Ligilactobacillus sp., wherein the Ligilactobacillus sp. is selected from the group consisting of Ligilactobacillus salivarius, and Ligilactobacillus saerimneri or combination thereof (broiler feed pellets or BFBs composition coated with Ligilactobacillus salivarius) (See for example, p. 3 left-hand column 2nd paragraph, and p. 2 Figure 1B and related legend).
Regarding claim 52, Wang et al. disclose method of inhibiting biofilm growth or reducing bacterial pathogen load on a surface, the method comprising treating a surface with the composition of claim 1 (coating broiler feed pellets (BFBs) by spraying a suspension comprising Ligilactobacillus salivarius) (See for example, p. 3 paragraphs 2.1.- 2.3.).
Regarding claim 54, although Wang et al. do inherently disclose the method is to reduce contamination of eggs, vegetables or other food surfaces, however because Wang et al. disclose the same step(s), i.e., treating a surface with the composition of claim 1, therefore the claimed properties, i.e., reduce contamination of eggs, vegetables or other food surfaces, not explicitly disclose are inherent to the method of Wang et al. (Also see MPEP 2112 II.).
Regarding claim 55, Wang et al. disclose the surface is a food preparation surface, food storage surface or a hard surface (coating broiler feed pellets (BFBs) by spraying a suspension comprising Ligilactobacillus salivarius) (See for example, p. 3 paragraphs 2.1.- 2.3.).
Wang et al. therefore anticipate the claimed composition and method of inhibiting biofilm growth or reducing bacterial pathogen load on a surface.
Claim Rejections - 35 USC § 102/103
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.
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 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative under 35 U.S.C. 103 as obvious over Guerrero Sanchez et al. (Appl Microbiol Biotechnol. 2022 Jan;106(1):57-80. Epub 2021 Dec 10).
Regarding claim 1, Guerrero Sanchez et al. disclose a composition for preventing Gram-negative bacteria growth comprising Ligilactobacillus sp. and/or bacterial extracellular vesicle isolated from Ligilactobacillus sp., wherein the Ligilactobacillus sp. is selected from the group consisting of Ligilactobacillus salivarius, and Ligilactobacillus saerimneri or combination thereof (tablets, capsules, bacterial suspensions, comprising Ligilactobacillus sp., Ligilactobacillus salivarius) (See for example, p. 58, p.59 Table 1 -Continued on p. 60-62, “strains” and “mode of administration”, and p. 62 left-hand column paragraph below Table 1).
Regarding claim 3, although the strains of Ligilactobacillus salivarius disclosed by Guerrero Sanchez et al. do not have the claimed designation numbers of, UO.C 109, UO.C 121, and UO.C249 but they appear to be the same as the claimed Leuconostoc mesenteroides strains. It should be noted that a single strain can be deposited under different deposit numbers.
Therefore Guerrero Sanchez et al. anticipate the subject matter of claims 1 and 3.
In alternative,
Regarding claim 1, Guerrero Sanchez et al. teach a composition for preventing Gram-negative bacteria growth comprising Ligilactobacillus sp. and/or bacterial extracellular vesicle isolated from Ligilactobacillus sp., wherein the Ligilactobacillus sp. is selected from the group consisting of Ligilactobacillus salivarius, and Ligilactobacillus saerimneri or combination thereof (tablets, capsules, bacterial suspensions, comprising Ligilactobacillus sp., Ligilactobacillus salivarius) (See for example, p. 58, p.59 Table 1 -Continued on p. 60-62, “strains” and “mode of administration”, and p. 62 left-hand column paragraph below Table 1).
Regarding claim 3, although the strains of Ligilactobacillus salivarius disclosed/taught by Guerrero Sanchez et al. do not have the claimed designation numbers of, UO.C 109, UO.C 121, and UO.C249 but, however it appears to be the same as the claimed Leuconostoc mesenteroides strain. It should be noted that a single strain can be deposited under different deposit numbers.
Moreover, a person of ordinary skill in the art before the effective filing date of the invention knowing the health benefits of the probiotic Ligilactobacillus salivarius strains, would have been motivated to isolate a Ligilactobacillus salivarius by known and available techniques taught by the prior art and obtain a deposit number and further use it in the method according to the teachings of Guerrero Sanchez et al. do with a reasonable expectation or success in providing the claimed compositions and method of treating and/or preventing food poisoning and/or improving intestinal health and/or reducing bacterial pathogen load in a subject.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1, 16, 18, 19, 41, 42, 44, 48 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Guerrero Sanchez et al. (Appl Microbiol Biotechnol. 2022 Jan;106(1):57-80. Epub 2021 Dec 10).
The teachings of Guerrero Sanchez et al. with respect to the limitations of claims 1, 16, 18, 19, 41, 42, 48 and 49 were discussed above in detail.
Regarding claim 44, the composition is administered within 24 hours of hatching, it should be noted that the time/timing of the application of the composition in the method taught by Guerrero Sanchez et al. would have been optimized by a person of ordinary skill in the art before the effective filing date of the invention.
Conclusion(s):
No claim(s) is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KADE ARIANI whose telephone number is (571)272-6083. The examiner can normally be reached IFP, Monday - Friday, 8:00 AM -4:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571)272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KADE ARIANI/Primary Examiner, Art Unit 1651
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