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 .
This office action is in response to the application filed on December 26, 2023. The earliest effective filing date of the application is June 30, 2021.
Priority
The present application is a 371 National Stage Application of PCT/US2022/035501 which has a filing date of June 29, 2022.
Status of Application
The preliminary amendment filed on December 26, 2023 has been entered. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1 – 20
Withdrawn claims: None
Currently amended claims: 8
Newly cancelled claims: 21 and 22
Claims currently under examination: 1 – 20
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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, 6, 11, 13, and 16 – 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goodman et al (WO 2020172492 A2 – IDS Filed on May 28, 2024).
Regarding claim 1, Goodman teaches a method of making a food product (abstract; [138]). Goodman teaches the method comprises the steps of:
a. isolating and purifying bacteria from a culture to produce a “membrane preparation” (i.e., processing microorganism cells that are harvested from a culture medium to produce a protein product – [34]; [47]; [72]); wherein “membrane preparation” refers to a preparation from bacteria that is purified to enrich for membranes and the components (such as membrane proteins) thereof (i.e., said protein product comprises one or more of single cell protein, cell lysate, protein concentrate, protein isolate, protein extract, protein hydrolysate, free amino acids, peptides, and oligopeptides – [34]); and the “membrane preparation” comprises lipopolysaccharides (i.e., said protein product comprises endotoxins from the microorganism cells – [34]).
b. removing or deleting lipopolysaccharides from the “membrane preparation” (i.e., processing the protein product to reduce the concentration of said endotoxins – [4]; [46]; [87]); and
c. combining the “membrane preparation” with additional active and/or inactive materials in order to produce a final product such as a food (i.e., processing the protein product to produce a food product – [126]; [139]).
With respect to whether lipopolysaccharides are endotoxins, the instant specification states lipopolysaccharides are considered endotoxins ([03]; [07]).
Regarding claim 6, Goodman teaches the final product is a food product for animals (i.e., the food product is a food item, a food ingredient, a nutritional product, an animal feed product, or a pet food product – [139]).
Regarding claim 11, Goodman teaches the final product is a therapeutic composition in the form of a probiotic or medical food comprising bacteria or “membrane preparations” in an amount sufficient to alter the microbiome at a site of the dysbiosis (i.e., the food product is a probiotic food product or a prebiotic food product – [240]).
Regarding claim 13, Goodman teaches the final product is a dairy product such as milk (i.e., the food product comprises a dairy product, a dairy replacement product, a bakery product, a confection, a health or protein bar, a protein powder, a sports and/or energy drink, a protein shake, or a smoothie – [138]).
Regarding claims 16 – 18, Goodman teaches the bacteria of step (a) is Cupriavidus metallidurans ([72]; p. 50, Table 1, Cupriavidus metallidurans). The instant specification states Cupriavidus microorganisms are oxyhydrogen microorganisms ([27]). The instant specification states oxyhydrogen microorganisms are chemoautotrophic microorganisms ([15]). Therefore, the Cupriavidus metallidurans taught by Goodman is a chemoautotrophic microorganism and an oxyhydrogen microorganism.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman et al (WO 2020172492 A2 – IDS Filed on May 28, 2024) in view of Nakamura et al. (US 20190351389 – IDS Filed on May 28, 2024).
Regarding claims 2 and 3, Goodman teaches the “membrane preparations” are purified from one or more other bacterial components (i.e., endotoxins) by various methods ([87]).
Goodman does not explicitly state the concentration of endotoxin in the protein product is reduced by about 2-fold to about 6000-fold.
Nakamura teaches a method of reducing bacterial endotoxins, specifically lipopolysaccharide (Abstract; [0002]). Nakamura teaches by following the endotoxin removal method, endotoxins in a material containing endotoxins to be removed is removed ([0113]). Nakamura teaches the endotoxin content in the material containing endotoxins is reduced to 50% or less or 1% or less, as compared to the material prior to treatment ([0114]). In this case, a reduction to 50% relative to the material prior to treatment corresponds to a 2-fold reduction, and a reduction to 0 to 1% relative to the material prior to treatment encompasses a 6000-fold decrease. Nakamura further teaches the method is practical for removing endotoxins in food ([0040]; [0177]).
Goodman and Nakamura are combinable because they are concerned with the same field of endeavor, namely, reducing bacterial lipopolysaccharides (i.e., endotoxins). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have utilized the method of Nakamura to reduce the lipopolysaccharide (i.e., endotoxin) by about 2-fold to about 6000-fold because Nakamura provides that it was known for the reduction of lipopolysaccharide (i.e., endotoxin) by about 2-fold to about 6000-fold to be successfully achieved during the removal of endotoxins and published at the time of filing, which means it was within the general skill of a worker in the art to reduce the lipopolysaccharide (i.e., endotoxin) by about 2-fold to about 6000-fold, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP § 2144.07.
Claims 4, 5, 7 – 10, 12, 14, 15, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman et al. (WO 2020172492 A2 – IDS Filed on May 28, 2024) in view of Dyson et al. (US 20190390158 – IDS Filed on May 28, 2024).
Regarding Claim 4, Goodman does not teach the protein product comprises nucleic acids, and wherein the protein product is processed to reduce the concentration of said nucleic acids prior to step (c).
Dyson teaches methods of producing microbial protein isolates from microorganisms, such as chemoautotrophs, with lowered nucleic acid content ([0037]; [0048]; [0051]; [0061]). Dyson teaches one possible area of concern with respect to direct human consumption is the nucleic acid content of the nutrients ([0037]). Dyson teaches the ratio of nucleic acid content to protein should be less than three percent, if SCP is the only source of dietary protein ([0037]). Dyson teaches to enable utilization of a substantial amount of these sources of SCP for human nutrition, methods have been developed to reduce nucleic acid content several fold ([0037]). Dyson teaches the protein-rich biomass is used in human food or within a human food formulation ([0061]).
Goodman and Dyson are combinable because they are concerned with the same field of endeavor, namely, utilizing chemoautotrophic microorganisms to produce edible protein. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have reduced the nucleic acid content of the “membrane preparation” of Goodman prior to combining with additional active or inactive ingredients (i.e., (c) processing the protein to produce a food product), as taught by Dyson because nucleic acid consumption should be kept low, and it would have been obvious to one of ordinary skill in the art to have removed the nucleic acids from the “membrane preparation” before forming it into a food product.
Regarding Claim 5, Dyson teaches in certain embodiments, the nucleic acid content of the isolate is below 9% by weight ([0063]).
Regarding Claim 7, Goodman does not teach the food product is a meat analogue product.
Dyson teaches methods of producing microbial protein isolates from microorganisms, such as chemoautotrophs, with lowered nucleic acid content ([0037]; [0048]; [0051]; [0061]). Dyson teaches the protein-rich biomass is used in human food or within a human food formulation ([0061]). Dyson teaches the food product is a meat replacement and/or imitation meat products (i.e., a meat analogue product – [0432]).
It would have been obvious to one of skill in the art, at the time of filing the invention, to modify the method of Goodman to produce a meat analogue product as the final product, as claimed, because Dyson provides that it was known for protein isolates produced from chemoautotrophic microorganisms to be successfully used in meat analogue products and published at the time of filing, which means it was within the general skill of a worker in the art to select the specific type of food (i.e., meat analogue product) of the final product of step (c) above, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP § 2144.07.
Regarding Claim 8, Goodman does not teach the food product comprises at least about 10% of the protein product by weight.
Dyson teaches methods of producing microbial protein isolates from microorganisms, such as chemoautotrophs, with lowered nucleic acid content ([0037]; [0048]; [0051]; [0061]). Dyson teaches the protein-rich biomass is used in human food or within a human food formulation ([0061]). Dyson teaches a high protein product (HPP) with reduced nucleic acid content is produced by the method, and is used as a food ingredient ([0601]; Preparation: 1). Dyson teaches a food product made with the HPP comprises water to HPP in a 3:2 ratio (i.e., the food product comprises 40% protein – [0602]; Example 26).
It would have been obvious to one of skill in the art, at the time of filing the invention, to modify the method of Goodman to produce a food product comprising 40% protein as the final product, as claimed, because Dyson provides that it was known for a protein content of 40% to be successfully used in food products comprising proteins isolated from chemoautotrophic microorganisms and published at the time of filing, which means it was within the general skill of a worker in the art to select the specific protein content of the final product of step (c) above, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP § 2144.07.
Regarding Claim 9, Goodman does not teach the food product is a vegetarian or vegan food product.
Dyson teaches methods of producing microbial protein isolates from microorganisms, such as chemoautotrophs, with lowered nucleic acid content ([0037]; [0048]; [0051]; [0061]). Dyson teaches the protein-rich biomass is used in human food or within a human food formulation ([0061]). Dyson teaches in certain embodiments, the microorganism cells and/or organic matter as described herein are utilized in the production of a vegetarian or vegan food product ([0433]).
It would have been obvious to one of skill in the art, at the time of filing the invention, to modify the method of Goodman to produce a vegetarian or vegan food product as the final product, as claimed, because Dyson provides that it was known for protein isolates produced from chemoautotrophic microorganisms to be successfully used in vegetarian or vegan food products and published at the time of filing, which means it was within the general skill of a worker in the art to select the specific type of food (i.e., vegetarian or vegan food product) of the final product of step (c) above, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP § 2144.07.
Regarding Claim 10, Goodman does not teach the food product is an organic food product, a pesticide-free food product, a herbicide-free food product, a fungicide-free food product, an antibiotic-free food product, or a non-genetically-modified (non-GMO) food product.
Dyson teaches methods of producing microbial protein isolates from microorganisms, such as chemoautotrophs, with lowered nucleic acid content ([0037]; [0048]; [0051]; [0061]). Dyson teaches the protein-rich biomass is used in human food or within a human food formulation ([0061]). Dyson teaches the microorganism cells are utilized in the production of an organic food product and/or pesticide-free and/or herbicide-free and/or fungicide-free and/or antibiotic-free and/or non-genetically modified (non-GMO) food product ([0433]).
It would have been obvious to one of skill in the art, at the time of filing the invention, to modify the method of Goodman to produce a organic food product and/or pesticide-free and/or herbicide-free and/or fungicide-free and/or antibiotic-free and/or non-genetically modified (non-GMO) food product as the final product, as claimed, because Dyson provides that it was known for protein isolates produced from chemoautotrophic microorganisms to be successfully used in organic food products and/or pesticide-free and/or herbicide-free and/or fungicide-free and/or antibiotic-free and/or non-genetically modified (non-GMO) food products and published at the time of filing, which means it was within the general skill of a worker in the art to select the specific type of food (i.e., an organic food product and/or pesticide-free and/or herbicide-free and/or fungicide-free and/or antibiotic-free and/or non-genetically modified (non-GMO) food product) of the final product of step (c) above, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP § 2144.07.
Regarding Claim 12, Goodman does not explicitly state the food product comprises no animal protein or fat.
Dyson teaches methods of producing microbial protein isolates from microorganisms, such as chemoautotrophs, with lowered nucleic acid content ([0037]; [0048]; [0051]; [0061]). Dyson teaches the protein-rich biomass is used in human food or within a human food formulation ([0061]). Dyson teaches the product has no animal protein or fats ([0432]).
It would have been obvious to one of skill in the art, at the time of filing the invention, to modify the method of Goodman to produce a food product with no animal proteins or fats as the final product, as claimed, because Dyson provides that it was known for protein isolates produced from chemoautotrophic microorganisms to be successfully used in food products without animal proteins or fats and published at the time of filing, which means it was within the general skill of a worker in the art to select the specific type of food (i.e., a food product with no animal proteins or fats) of the final product of step (c) above, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP § 2144.07.
Regarding Claim 14, Goodman does not teach the food product comprises one or more plant protein source.
Dyson teaches methods of producing microbial protein isolates from microorganisms, such as chemoautotrophs, with lowered nucleic acid content ([0037]; [0048]; [0051]; [0061]). Dyson teaches the protein-rich biomass is used in human food or within a human food formulation ([0061]). Dyson teaches the microorganisms comprise a cell line selected from eukaryotic plants ([0265]).
It would have been obvious to one of skill in the art, at the time of filing the invention, to modify the method of Goodman to produce a food product that comprises one or more plant proteins as the final product, as claimed, because Dyson provides that it was known for protein isolates produced from eukaryotic plants (i.e., plant protein sources) to be successfully used in food products and published at the time of filing, which means it was within the general skill of a worker in the art to select the specific type of protein source (i.e., eukaryotic plants) of the final product of step (c) above, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP § 2144.07.
Regarding Claim 15, Goodman does not teach the food product comprises an insect or algae protein source.
Dyson teaches methods of producing microbial protein isolates from microorganisms, such as chemoautotrophs, with lowered nucleic acid content ([0037]; [0048]; [0051]; [0061]). Dyson teaches the protein-rich biomass is used in human food or within a human food formulation ([0061]). Dyson teaches the microorganisms comprise a cell line selected from algae ([0265]).
It would have been obvious to one of skill in the art, at the time of filing the invention, to modify the method of Goodman to produce a food product that comprises one or more algae proteins as the final product, as claimed, because Dyson provides that it was known for protein isolates produced from algae (i.e., algae protein sources) to be successfully used in food products and published at the time of filing, which means it was within the general skill of a worker in the art to select the specific type of protein source (i.e., algae) of the final product of step (c) above, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP § 2144.07.
Regarding Claim 19, Goodman does not teach the bacteria of step (a) is Cupriavidus necator DSM 531 or DSM 541.
Dyson teaches methods of producing microbial protein isolates from microorganisms, such as chemoautotrophs, with lowered nucleic acid content ([0037]; [0048]; [0051]; [0061]). Dyson teaches the microorganism is Cupriavidus necator DSM 531 or DSM 541 ([0331]).
It would have been obvious to one of skill in the art, at the time of filing the invention, to modify the method of Goodman to utilize Cupriavidus necator DSM 531 or DSM 541 as the bacteria of step (a), as claimed, because Dyson provides that it was known for Cupriavidus necator DSM 531 or DSM 541 to be successfully used as bacteria for producing protein products and published at the time of filing, which means it was within the general skill of a worker in the art to select Cupriavidus necator DSM 531 or DSM 541 as the bacteria of step (a), because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP § 2144.07.
Regarding Claim 20, Goodman teaches the purification of step (a), is achieved by lysing the cells (i.e., freeing organic molecules from the microorganism cells, via excretion, secretion, or cell lysis, or a combination thereof, wherein the organic molecules comprise proteins – [87]).
Goodman does not teach treating the freed organic molecules to hydrolyze peptide bonds between at least a portion of amino acids in at least a portion of the proteins, thereby producing a hydrolysis protein product that comprises polypeptides comprising 20 to 50 amino acids, oligopeptides comprising 2 to 20 amino acids, and/or free amino acids.
Dyson teaches methods of producing microbial protein isolates from microorganisms, such as chemoautotrophs, with lowered nucleic acid content ([0037]; [0048]; [0051]; [0061]). Dyson teaches proteins produced by the method are hydrolyzed, thereby producing a hydrolysate ([0086]). Dyson teaches hydrolyzing comprises at least one enzyme that is capable of hydrolyzing proteins into at least one of free amino acids and oligopeptides ([0086]).
It would have been obvious to one of skill in the art, at the time of filing the invention, to modify the method of Goodman to hydrolyze the microbial protein isolates (i.e., freed organic molecules), as claimed, because Dyson provides that it was known for hydrolyzation of microbial protein isolates (i.e., freed organic molecules) to be successfully used in food products and published at the time of filing, which means it was within the general skill of a worker in the art to select the specific method of preparing final products (i.e., hydrolyzing the “membrane preparation), because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP § 2144.07. Furthermore, given the disclosure of Dyson refers to the hydrolysis resulting in amino acids, and oligopeptides in the plural, the disclosure implies the hydrolysis results in at least two amino acids and/or oligopeptides. The range of amino acids from hydrolysis, at least two, as disclosed by Dyson, overlaps with the claimed range of 2 to 20. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARK JULIA MORENO whose telephone number is (571)272-2337. The examiner can normally be reached 6:30 - 4:30 M - F.
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/L.J.M./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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