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 .
Claim Status
Claims 1-11 and 17-19 are currently bending in the application and claims 13, 14, and 16 have been withdrawn from consideration. Claims 12 and 15 are cancelled.
Claim Objections
The claim objections filed 01 April 2025 have been overcome by the amendments filed 01 July 2025.
Claim Rejections - 35 USC § 112
The 112(b) rejections filed 01 April 2025 have been overcome by the amendments filed 01 July 2025.
Claim Rejections - 35 USC § 102
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 1-2, 8, and 17 are rejected under 35 U.S.C. 1029(a)(1) as being anticipated by De Haan et al. (herein referred to as De Haan, EP 0986960).
With regard to Claim 1, De Haan teaches a method for producing a biomass composition (abstract). The composition comprises an antioxidant ([0043], De Haan read such that a chelating agent (e.g., citric acid) can be added to the fermentation broth containing the biomass) and biomass ([0009]). De Haan teaches providing a biomass ([0083]), adding an antioxidant to the biomass to obtain a biomass mixture ([0043] De Haan reads such that this is the only step in which the citric acid is added), pasteurizing the biomass composition to obtain the biomass composition ([0083]) and optionally washing the biomass composition ([0127], De Haan reads such the biomass is washed after centrifugation from the fermentation broth).
With regard to Claim 2, De Haan teaches the antioxidant is a chelating agent such as citric acid ([0043]).
With regard to Claim 3, De Haan teaches the biomass composition of Claim 1. Therefore, because the identical composition is taught by De Haan, the composition would inherently have a TOTOX value of under 50. See MPEP 2112.01 “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)”
With regard to Claims 8 and 17, De Haan teaches the biomass is a biomass derived from the fungal strain Rhizomucor ([0014], [0099], [0117]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over De Haan (EP 0986960) in further view of Clark et al. (herein referred to as Clark, WO 2019226759 A1)
With regard to Claim 5, De Haan discloses all the limitations in the claims set forth above.
However, De Haan is silent to the biomass comprising at most 500 mg/kg dry matter iron.
Clark teaches a method to prepare a myceliated vegetable product which includes culturing fungi in an aqueous media which contains vegetables, fruits, and/or combinations thereof (abstract). Clark teaches the myceliated product contains a nutritional profile comprising a measurable level of iron ([0004]). Clark teaches in the myceliated vegetable product has iron at a level of at least 50 micrograms/g dry weight ([0005] 1 microgram/g is equivalent to 1 mg/kg). See MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions. Clark teaches iron is a substance that enhances the nutritional profile of the myceliated vegetable-containing product ([0034]).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify De Haan in view of Clark to include biomass with an iron at a level of at least 50 micrograms/g dry weight ([0005] 1 microgram/g is equivalent to 1 mg/kg) to enhance the nutritional profile of the biomass ([0034]).
Claims 4, 6, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over De Haan (EP 0986960).
With regard to Claim 4, De Haan teaches the biomass is derived from a fermentation broth ([0051], [0083]). De Haan teaches the water can be removed from the fermentation broth using mechanical techniques such as filtration, centrifugation, settling and/or drying ([0083]). Filtering the biomass reads on the claimed limitation of the fermentation broth being sieved to obtain the biomass.
With regard to Claim 6, De Haan discloses all the limitations in the claims set forth above.
De Haan teaches the pH, temperature and/or oxygen content (of the aqueous liquid) during fermentation is controlled ([0044]). The pH of the aqueous liquid during fermentation may be from 4 to 10 ([0045]). See MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions. De Haan teaches the biomass may be subjected to pasteurization either if the fungal cells are still in the aqueous liquid (i.e., broth) or if they have been subjected to water removal steps ([0064]).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that De Haan reads such that the aqueous liquid during fermentation (i.e., the broth) can have a pH at most 4.5 and that broth may undergo pasteurization thus reading on the claimed limitations.
.With regard to Claims 10 and 11, De Haan discloses all the limitations in the claims set forth above.
De Haan teaches the fungal cells may then be subjected to heat treatment and/or pasteurization ([0064]). If heat treatment is employed, the fungal cells can be heated to a temperature of from 55 to 150°C, such as from 80 to 100°C, optimally from 90 to 95°C. This may be for a time from 5 to 120 minutes such as from 20 to 60 minutes, optimally from 25 to 40 minutes ([0057]). See MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
It would have been obvious to one with ordinary skill in the art that the above-described conditions (time and temperature) for a heat treatment coincide with conditions that would be applicable for a pasteurizations step and read on the limitations of the instant claims.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over De Haan (EP 0986960) in further view of Ogura (JP 6301080 B2) and Bijl et al. (herein referred to as Bijl, WO 9737032 A2)
With regard to Claim 3, De Haan discloses all the limitations in the claims set forth above.
However, De Haan is silent to the TOTOX value of the composition.
Ogura teaches an oil and fat composition for use in foods and a method for producing the same (abstract). Ogura teaches the TOTOX value is an evaluation method that was developed taking into consideration the presence of peroxides produced by the oxidation of fats and oils and specific aldehyde compounds that are secondary products of their decomposition ([0009]). Conventionally TOTOX has often been used to judge the quality of fats and oils such as deterioration, but the Ogura has experimentally discovered that the hardened oil flavor in partially hydrogenated fats and oils has a certain relationship with the TOTOX value ([0009]). The art teaches that compositions having a TOTOX value of 24.5 or more and a peroxide value of 8 or less had a good flavor evaluation ([0034]). See MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
However, Ogura is silent to the composition being a biomass.
Bijl teaches a polyunsaturated fatty acid-(PUFA) containing oil, especially to a pure and stable microbial oil containing at least one polyunsaturated fatty acid. This oil can be obtained from a biomass or fermentation broth that has been subjected to pasteurization (page 1, lines 9-12). Typically, a microbial species producing a lipid containing the desired polyunsaturated fatty acids is cultured in a suitable medium, the biomass is then harvested and pretreated to enable subsequent extraction of lipid from the biomass (page 1 lines 32-35). Bijl teaches oxidation of the oil negatively affects the quality of the oil (page 2, lines 23-26) Bijl teaches the microbial biomass from which the oil of the invention can comprise, or originate from, any type of microorganism able to produce a PUFA - containing oil, for example a bacterium, a yeast, a fungus or an algae (or a mixture thereof) (pages 5-6, lines 35-2). Bijl teaches compositions which contain the microbial oil may be a food or feed stuff to a nutritional supplement either for humans and/or animals (page 10, lines 3-80).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify De Haan in view of Ogura and Bijl. Ogura teaches the TOTOX value is used to judge the fats and oils, and if the oil and fat compositions have a TOTOX value of 24.5 or more they have a good flavor evaluation. Bijl teaches a biomass composition, which contains fungus, contains polyunsaturated fatty acid-(PUFA) oil which can be negatively affected by oxidation (page 2, lines 23-26). One with ordinary skill in the art would recognize that PUFA oil can be hydrogenated. Bijl teaches compositions containing the microbial oil may be a food or feed stuff to a nutritional supplement either for humans and/or animals (page 10, lines 3-80). Therefore, Bijl imparts reasoning for obviousness that the claimed composition would contain oils such as PUFA because fungal biomass has been shown to contain oils which can be negatively affected by the oxidation of said oils. Thus, modifying De Haan in view of Ogura to incorporate a TOTOX value of 24.5 or more, which reads on the instant claims, would advantageously give the biomass a good flavor evaluation.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over De Haan (EP 0986960) in further view Bijl (WO 9737032 A2)
With regard to Claim 7, De Haan discloses all the limitations in the claims set forth above.
However. De Haan is silent to the biomass comprising at least 7% dry matter.
Bijl teaches using fungus as a microbial biomass for obtaining an oil from the biomass (pages 5-6, lines 35-2, page 6 lines 23-27). Bijl teaches the biomass with a dry matter content from 25 to 80% (page 6, lines 28-29). See MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions Bijl teaches the water content at various stages can also influence yields. Too high a dry matter content, and the biomass will crumble and may form fines or dust, which is disadvantageous if a filtration extraction method is employed. However, too high a water content and one obtains a slurry that is too wet to be made into granules (page 10, lines 19-24).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify De Haan in view of Bijl to utilize a biomass with a water content of from 25 to 80% (page 6, lines 28-29) because water content can directly affect achievable yields of the expected compound and the ability to further downstream process the biomass (page 10, lines 19-24).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over De Haan (EP 0986960) in further view Fichtali et al. (herein referred to as Fichtali, WO 2006124598 A2)
With regard to Claim 9, De Haan discloses all the limitations in the claims set forth above.
However, De Haan is silent to the pasteurization being performed in an in-line heating unit.
Fichtali teaches to a process for preparing a biomass, such as from a microbial fermentation, for an extraction process to separate desired chemicals, nutritional products, bioactive components, proteins, carbohydrates, and lipids, from the biomass (abstract). Fichtali teaches the biomass comprises a microorganism and specifically can comprise fungi (Claim 13). Fichtali teaches pasteurization of the biomass is employed after the fermentation reaction is complete, but before a solid/liquid separation step for removing the biomass from the fermentation broth (page 18 lines 19-21). Pasteurization may be accomplished using direct or indirect methods. For example, the pasteurization may be accomplished by heating directly with steam into the liquid or broth or indirectly, through heat exchangers (page 18 lines 24-26). IN one embodiment, Fichtali teaches a continuous High Temperature Short Time (HTST) process for pasteurization (page 18 lines 33-34).
Therefore, Fichtali imparts reasoning for obviousness because the teaching shows that the claimed process of in-line (also known as continuous) pasteurization with a heating unit was known to have been successfully achieved and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select continuous pasteurization (such as HTST) because it would have been obvious to one with ordinary skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious. In addition, Fichtali reads such that the heating unit is a heat exchanger (page 18 lines 24-26).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over De Haan (EP 0986960) in further view of De Laat et al. (herein referred to as De Laat, WO 2018029353 A1)
With regard to Claims 18 and 19, De Haan discloses all the limitations in the claims set forth above.
De Haan teaches using fugus from the group Rhizomucor but is silent to the strain being Rhizomucor pusillus strain CBS 143028.
De Laat teaches a process for producing single cell protein with a thermophilic fungus (abstract). De Laat teaches the thermophilic fungus is preferably from the strain Rhizomucor pusillus CBS 143028 (Page 3, line 37).
Therefore, De Laat imparts reasoning for obviousness because the teaching shows that the claimed strain of fungus was known for such a thing to have been successfully achieved and published at the time of filing which means it was within the general skill of one with ordinary skill in the art to select the Rhizomucor pusillus CBS 143028 fungus strain, 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 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
Response to Arguments
Applicant's arguments filed 01 July 2025 have been fully considered but they are not persuasive.
Applicant argues with regard to Claim 1 that De Haan does not discuss or mention antioxidants anywhere. However, in paragraph [0043] De Haan teaches adding citric acid as a chelator. Per applicant’s instant claim 2, a suitable antioxidant is a chelator. It is also well known in the art that citric acid is an antioxidant. Therefore, the applicants argument is not found to be persuasive.
Applicant argues that the TOTOX value is an attractive technical result that could not be reasonably expected from the cited prior art. De Haan teaches the claimed steps ii, iii, and iv in which applicant states is critical to the TOTOX value. Ogura and Bijl then support a TOTOX value in the claimed range and give motivation to combine. Therefore, the applicants argument is not found to be persuasive. The examiner notes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792