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 .
Status of the Claims
Claims 1-20 are pending (claim set as filed on 10/04/2023).
Priority
This application is a 371 of PCT/FI2022/050264 filed on 04/22/2022, which has a foreign application to FI 20215493 filed on 04/28/2021.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 10/04/2023 and 10/04/2024 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the Examiner.
Drawings
The drawings filed on 10/04/2023 have been accepted.
Claim Suggestions
For dependent claims, it is suggested that they recite “The method according to claim” merely for antecedent clarity and differentiating between an independent versus dependent claim.
Claim Rejections - 35 USC §112(a), Biological Deposit
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.
Claims 11 and 19 are rejected under 35 U.S.C. 112(a) 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 invention appears to employ the specific “bacterial strain VTT-E-193585 or a derivative thereof”. 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 noted in the amendment to the abstract filed on 10/04/2023. 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(a) in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration or statement 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.
Claim Rejections - 35 USC §102, Anticipation
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 1-10, 12-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zahn (WO 2021/055366 A1 - cited by the ISA and in the IDS filed on 10/04/2023).
Zahn’s general disclosure relates to the fields of protein hydrolysates produced from
biological sources, and methods of making the same and formulating the same into various end products (see abstract & ¶ [02]). Zahn discloses that protein and protein hydrolysates can serve as a bio-stimulant or plant nutrient to promote growth of plants in soil, fungi, or microorganisms (i.e., a cell growth medium) (see ¶ [03]).
Regarding claim 1, Zahn teaches “a process for producing a biologically derived protein hydrolysate … the process comprises the steps of: (1) culturing a microorganism in the presence of a carbon source in an aerobic or microaerobic bioprocess to grow biomass containing protein, wherein the microorganism comprises Cupriavidus necator and the carbon source comprises carbon dioxide; (2) harvesting the biomass, which contains protein, into a suspension composition; (3) if the pH of the suspension composition is not within a first target pH range, adjusting the pH of the suspension composition to a pH within the first target pH range, and wherein the first target pH range is at least about 10, thereby forming an alkaline suspension composition; (4) heating the alkaline suspension composition to a first temperature of at least about 40°C for a first time period of at least about 5 minutes; (5) forming a neutralized suspension composition by adding a neutralizing agent to the alkaline suspension composition, wherein the pH of the neutralized suspension composition is within a second target pH range, and wherein the second target pH range is from about 6.5 to about 9.5; (6) optionally further hydrolyzing the proteins by adding a protease to the neutralized suspension composition and incubating the neutralized suspension composition at a second temperature range for a second time period, wherein the second temperature range is at least about 40°C and the second time period is at least about 1 hour, thereby forming a hydrolyzed protein suspension; and (7) capturing the supernatant containing the hydrolyzed protein from the hydrolyzed protein suspension” (see ¶ [06], [35]). Zahn further teaches that the method includes processing a proteinaceous material with a combination of physical, chemical and/or enzymatic treatments (see ¶ [14]) and further teaches the biomass is suspended in the liquid medium by vortexing, homogenizing, stirring, or sonicating (see ¶ [29]). Zahn teaches at least a portion of the protein is hydrolyzed by the step of heating the alkaline or acidic suspension composition to a first temperature for a first time period; the suspension composition comprises a lysate; the step of harvesting the protein from the biomass into a suspension composition comprises subjecting the biomass to lysis (see ¶ [53]-[55]).
Regarding claim 2 pertaining to the separation, Zahn teaches the process further
includes: separating a liquid supernatant from solid material in the alkaline hydrolysate
suspension or the protease hydrolysate suspension, wherein the supernatant comprises soluble
hydrolyzed microbial protein (see ¶ [07]). The method includes separating an insoluble fraction of the suspension from the soluble fraction (see ¶ [26]). The method further comprises the additional step of clarifying the suspension through centrifugation or filtration to remove undissolved material in the hydrolyzed protein suspension (see ¶ [49]-[51], [150]-[151]).
Regarding claim 3 pertaining to the heat treatment, Zahn teaches heating the alkaline suspension composition to a first temperature of at least about 40°C for a first time period of at least about 5 minutes (see ¶ [07]).
Regarding claims 4 and 9 pertaining to drying, Zahn teaches the method further comprises the additional step of drying the captured supernatant and lyophilizing the hydrolyzed protein (see ¶ [51]). Zahn teaches the dewatered product is dried using heat and/or evaporation, employing a method such as spray drying (see ¶ [152]).
Regarding claims 5 and 16 pertaining to the enzyme, Zahn teaches enzymatic hydrolysis comprises hydrolyzing with at least one enzyme selected from papain, a neutral protease, Alcalase, trypsin, pepsin (see ¶ [145]).
Regarding claim 6 pertaining to the temperature, Zahn teaches heating to a temperature range of about 40-150°C or from about 110-125°C (see ¶ [42], [131], [138]).
Regarding claim 7 pertaining to the pH, Zahn teaches “neutralizing the alkaline suspension composition by adding a neutralizing agent to the alkaline suspension composition, thereby forming a neutralized suspension composition, wherein the pH of the neutralized suspension composition is within a second target pH range of about 6.5 to about 9.5” (see ¶ [07], [32], [38], [134]).
Regarding claims 8 and 17 pertaining to the protease temperature, Zahn teaches the conditions of pressure, temperature, pH and time of the enzymatic hydrolysis are those in which maximum or a suitable level of enzyme activity is achieved; the suspension may be incubated with the protease at a suitable pH and temperature for suitable or optimal catalytic activity of the specific protease that is utilized, and for a suitable amount of time to achieve the desired amount of proteolysis. In one embodiment, the suspension is incubated at about 55°C (see ¶ [145]-[147]).
Regarding claims 10 and 18 pertaining to the gas fermentation, Zahn teaches the protein hydrolysate composition may be sustainably produced from CO2, CH4, CO, and/or other carbon containing gases that are greenhouse gases (GHGs) or sources of pollution, e.g., air pollution (see ¶ [13]).
Regarding claims 12-14 pertaining to the bioreactor, Zahn teaches microbe cultures grown in, e.g., a bioreactor. The bioreactor may be configured to use waste or low value sources of carbon, such as CO2, to culture the oxyhydrogen microbe (see ¶ [13], [82]). Zahn teaches the method includes separating an insoluble fraction of the suspension from the soluble fraction (see ¶ [26]). The method further comprises the additional step of clarifying the suspension through centrifugation or filtration to remove undissolved material in the hydrolyzed protein suspension (see ¶ [49]-[51], [150]-[151]).
Regarding claim 15 pertaining to the spray dryer, Zahn teaches the dewatered product is dried using heat and/or evaporation, employing a method such as spray drying (see ¶ [152]).
Regarding claim 20 pertaining to the growth medium, Zahn teaches a composition or formulation comprising the hydrolyzed microbial protein exhibits greater growth of plants or has use in nutritional or medicinal applications for animals and humans (see ¶ [12]-[13], [40]).
Claim Rejections - 35 USC §103, Obviousness
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 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 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 non-obviousness.
Claims 11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Zahn as applied to claims 1-10, 12-18, and 20 above, and in view of Larsen (Genetic analysis of pigment biosynthesis in Xanthobacter autotrophicus Py2 using a new, highly efficient transposon mutagenesis system that is functional in a wide variety of bacteria, 2002).
Zahn’s teachings are discussed above. Note that Zahn teaches the microorganism includes the species Xanthobacter autotrophicus, flavus, or other Xanthobacter species (see page ¶ [159], [168], [171]).
However, Zahn does not specifically teach: wherein the microbial cells comprise an isolated bacterial strain VTT-E-193585 or a derivative thereof (claims 11 and 19).
Larsen teaches “Xanthobacter autotrophicus Py2 is classified in the α-subdivision of the Proteobacteria and was originally isolated for its ability to grow on propylene as sole carbon source. This strain was observed to be metabolically quite diverse and has the ability to grow on H2/CO2, ketones, alcohols, sugars, carboxylic acids, and aliphatic alkenes” (see page 193: Introduction). Larsen discloses Xanthobacter autotrophicus Py2 are gram-negative (see page 194, left col. & page 197, left col.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ or substitute Larsen’s Xanthobacter autotrophicus Py2 strain as the microbial biomass to be cultivated by gas fermentation in the teachings of Zahn. The ordinary artisan would have been motivated to do so is because Zahn first discloses micro-organism that includes Xanthobacter autotrophicus, flavus, or other Xanthobacter species (see Zahn at page ¶ [159], [168], [171]) as possible options to produce protein hydrolysates. Turning to the secondary reference, Larsen has a teaching-suggestion-motivation (TSM) that the Xanthobacter autotrophicus Py2 strain was observed to be metabolically quite diverse and has the ability to grow on H2/CO2 (see Larsen at page 193: Introduction). Thus, it would have been readily apparent to one ordinary skill in the art to either combine or substitute Larsen’s Xanthobacter autotrophicus Py2 strain as the microbial biomass in Zahn’s teachings for the production of protein hydrolysates. Moreover, the prior art strain of Larsen appears to be an obvious variant or substantially similar to the claimed strain because both the claimed strain and reference strain appear to be gram-negative bacterium, can be grown in a broad range of conditions, utilizes hydrogen gas as energy source and carbon dioxide as carbon source (as compared from the instant specification at page 8 with Larsen’s Xanthobacter autotrophicus Py2 strain). Accordingly, the claimed strain and the reference strain appear to be structurally and/or functionally equivalent and in the absence of evidence to the contrary, there does not appear to be difference that arises to a level of patentable significance within the meaning of §103.
Conclusion
No claims were allowed.
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653