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 03/13/2026).
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.
Withdrawal of Rejections
The response and amendments filed on 03/13/2026 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated herein for brevity, have been withdrawn necessitated by Applicant’s formality corrections and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s response to arguments section.
Briefly, the previous §112(a) biological deposit claim rejection has been withdrawn necessitated by Applicant’s statement of procedural deposit assurance of biological material.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Maintained Rejections
Claim Rejections - 35 USC §102, Anticipation
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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]).
Maintained Rejections
Claim Rejections - 35 USC §103, Obviousness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Examiner’s Response to Arguments
Applicant’s arguments filed on 03/13/2026 have been fully considered but they are not persuasive and deemed insufficient to overcome the prior art(s) of record.
In response to Applicant’s argument (addressing pages 6-7 of the remarks) that Zahn does not teach high-pressure homogenization as described in P.11 lines 19-21 of the specification which discloses it reduces endotoxin response of the final protein hydrolysate by 10-1000 fold: this argument is not persuasive because note that the claims are interpreted under the broadest reasonable interpretation (BRI) standard where it is interpreted in light of the specification but it is improper to import limitations from the specification into the claims (MPEP 2173.01). In regards to “Zahn appears to be silent on any consideration of endotoxin content of the final protein hydrolysate”, not that the current claims do not recite reduction of endotoxins in the obtained protein hydrolysate. Moreover, the phrase “high pressure homogenization” is a relative term such that the prior art of Zahn would read on said phrase under BRI, for instance, Zahn teaches the suspended biomass was homogenized with IKA T25 Turrax stick at 15000 rpm for 1 min (see page 54: Example 1). In other words, the claim does not reflect the homogenization pressure conditions such as from 900 bars up to 2000 bars.
In response to Applicant’s argument (addressing page 9 of the remarks) that “Larsen does not teach the Xanthobacter cultivation of the claimed invention, is silent on endotoxins and the generation of protein hydrolysates for cell culture growth medium and does not appear to have any teaching which would prompt a person of ordinary skill in the art to seek out Zahn’s predominantly C. necator protein hydrolysates for plant bio-stimulus”: this argument is not persuasive because note that Zahn is not restricted to only the use of C. necator but rather, Zahn allows for other microorganisms including the species Xanthobacter autotrophicus, flavus, or other Xanthobacter species (see Zahn at page ¶ [159], [168], [171]). Moreover, the MPEP 2123 states that “a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” and “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments”. In other words, the primary reference of Zahn is not particularly limited to a preferred example (e.g., DSM 432 or four other DSM strains). 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).
In response to Applicant’s argument (addressing page 10 of the remarks) that Zahn teaches away from the method of claim 1 as the extraction step teaches lipid solubility in organic solvents where the “Filtrate collected had lipids extracted out” (Examples 10-13): this argument is not persuasive because the claims does not mention lipid solubility nor that lipid A/endotoxin would be retained in the aqueous phase in which Applicant asserts to be critical aspect of the claimed invention.
Conclusion
No claims were allowed.
Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGHI V NGUYEN whose telephone number is (571)270-3055. The examiner can normally be reached Mon-Fri: 9 - 3 pm (EST).
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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