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 Application
1-3, 5-11 and 13-14 are pending. Claims 4 and 12 have been cancelled. The previous claim objections have been withdrawn in view of applicant’s amendments to the claims. The previous 103 have been modified in view of applicant’s amendments to the claims.
Claim Interpretation
Claim 3 recites wood sawdust and wood meal without specifying the difference between the two. For the purpose of examination, wood sawdust and wood meal will be interpreted as indicated in the specification, sawdust is sized between 1mm and 2cm and wood meal is sized between 20µm and 1mm (instant specification, p5 1st full para).
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 1-3, 5-11 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Holliday (US 2014/0248395 A1) in view of Sutter (WO 2015/101650 A2), Medoff (US 2015/0353974 A1) and Sales-Campos (Sales-Campos, Ceci et al. “MINERAL COMPOSITION OF RAW MATERIAL, SUBSTRATE AND FRUITING BODIES OF Pleurotus Ostreatus IN CULTURE.” Interciencia 34.6 (2009): 432–436. Print) as evidenced by Piškur (Piškur et al., Influence of Pleurotus ostreatus inoculation on wood degradation and fungal colonization, Bioresource Technology, Vol. 102, (22), 2011, Pages 10611-10617).
All citations to Sutter refer to the pages of the English translation.
Regarding claims 1, 5, 6 and 14; Holliday discloses a method for bioconversion of cellulosic material into protein suitable for use as an animal feed supplement where the cellulosic substrate is sawdust or wood chips (wood residue) [0001] and [0014], which meets the claim limitation of a method for transforming wood residues into an edible food product for an animal.
Holliday discloses combining the cellulosic substrate with one or more desired fungal microorganisms and allowing the fungal microorganisms to achieve a desired level of bioconversion of the substrate to produce fungal mass and proteinaceous material [0007]-[0011]. Holliday discloses the cellulosic substrate is sawdust or woodchips [0014] and the fungus can be Pleurotus ostreatus (a wood destroying edible fungus) [0016]. Holliday’s combination of wood chips or sawdust with Pleurotus ostreatus and allowing the fungal microorganisms to achieve a desired level of bioconversion of the substrate meets the claim limitation of “performing a first fermentation by applying a wood destroying edible fungus to a substrate composed of wood residues for a suitable duration.”
Holliday also discloses “Even though known and normally edible mushroom species are preferred for this process, it is important to realize that growth for a long enough period of time to produce the fleshy spore bearing fruitbody (the mushroom) is not necessary nor generally desirable, as nearly complete conversion of the cellulosic material into fungal tissue and fungal byproducts occurs far sooner than the production of mushrooms. From a simply economic perspective, it is desirable to harvest and utilize the proteinaceous fungal biomass as soon as practical” [0050]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have harvested the fungal biomass (stop the fermentation) before the production of the mushroom (fructification) and at the nearly complete conversion of the cellulosic material into fungal tissue (maximum colonization of the substrate) because Holliday discloses it is economically advantageous and there is nearly complete conversion of the cellulosic material to fungal biomass, one of the goals of the disclosed process.
Holliday does not disclose heat inactivation of said wood destroying edible fungus and grinding a product obtained from said first fermentation nor the second fermentation step with a fungus of the Aspergillus genus.
Sutter, in the field of using fungal strains for the production of fermented solid edible food products for animal feed, discloses the use of at least one strain of lower or filamentous fungus for the preparation of a fermented solid edible product intended for animal consumption from a by-product derived from plants. Sutter discloses the filamentous fungus can be a strain of Aspergillus sojae or Aspergillus oryzae (p2, lines 72-77). Sutter disclose the by-product derived from plants is defined as the residues or wastes from the agricultural and agrifood industries, which would include wastes from forestry (p4, lines 130-131).
Sutter discloses that in an advantageous embodiment the method further includes a step of inactivating said molds to prevent the further multiplication of the molds and to thus stabilize the food product. Sutter discloses the inactivation can be done by a thermal heat treatment (p7, lines 270-277).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the method of bioconversion of cellulosic material into protein suitable for use as an animal feed supplement of Holliday with the heat inactivation and fermentation of plant by-products with Aspergillus sojae or Aspergillus oryzae for production of edible food products for animals of Sutter because both are drawn to the conversion of wastes from the agricultural industries by fermentation with fungi into edible food products for animals.
As to the claim limitation of claim 1, step 2) which requires grinding the substrate, Medoff discloses a method to process a first material, biomass, to produce a second material that can be used as a substrate for the cultivation or growth of mushrooms which can then be ingested by animals [0667]. Medoff discloses the biomass can be trees, wood wastes and residues such as softwood forest thinnings, barky wastes, sawdust, wood fiber and then like [0116]. Medoff discloses the biomass feedstock is pretreated to reduce the one or more dimension of the individual pieces of biomass by grinding, cutting, smashing or crushing [0019].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the method of bioconversion of cellulosic material into protein suitable for use as an animal feed supplement of Holliday with the grinding of the substrate of Medoff because both Holliday and Medoff are drawn to the use of wood residue substrates for the growth of fungi (mushrooms).
As to the order of the claimed method steps, Holliday in view of Sutter and Medoff does not disclose the same order of method steps as recited in the instant claims. However, selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. MPEP 2144.04 IV. C.
As to the two fermentation steps of the instant claims, Holliday in view of Sutter and Medoff does not disclose sequential fermentation by the claimed fungi. However, the Holliday and Sutter both disclose methods of fermenting wood residues with the use of fungi and the claims recite no extent of fermentation by the fungi (i.e. how much of the wood residues are fermented versus how much of the wood residue remains unfermented after each step.) It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have elected to combine the fermentation of Holliday with a second fermentation step disclosed by Sutter in order to ferment the wood residues remaining after the fermentation of Holliday and maximize the conversion of the wood residues into useable animal feed.
As to the claim limitation of claim 1, step 3) “for a suitable duration corresponding to the maximum colonization of the substrate before sporulation by said fungus”, the same argument applies here as above. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have harvested the fungal biomass (stop the fermentation) before the sporulation and at the nearly complete conversion of the cellulosic material into fungal tissue (maximum colonization of the substrate) because Holliday discloses it is economically advantageous and there is nearly complete conversion of the cellulosic material to fungal biomass, one of the goals of the disclosed process.
Holliday in view of Sutter and Medoff does not disclose an alkalinizing mineral supplement nor the ingredients therein.
Sales-Campos, in the field of culturing Pleurotus ostreatus, discloses mineral elements are necessary for the fruiting of the mushrooms. Sales-Campos discloses potassium, phosphorus, magnesium and calcium are necessary elements and they stimulate mycelium growth (p432, Introduction, col 2-3). Sales-Campos discloses potassium is very important because it is a co-factor of several enzymatic systems (p432, col 4).
Sales-Campos discloses Fe, Mn, Cu and Zn are among the most essential micronutrients for the growth of many species of fungi (p432, col 4), which meets the claim limitation of metals which are cofactors of digestive enzymes secreted by fungi (claim 1) and the list of metals in claim 14.
As to the quantity of the Ca, K, Mg and P in claim 1, Sales-Campos does not disclose a concentration of Ca, K, Mg and P. However, it is known in the art that the quantity of mineral supplement is a result effective variable, when you change the concentration of the mineral supplements you change the growth rate of the mycelium. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. Additionally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05 II A. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the method disclosed by the prior art by normal optimization procedures known in the art.
Sales-Campos further discloses other supplements like limestone or CaCO3 (an alkalinizing mineral supplement) must be added to the cultivation medium to maintain a pH favorable to fungus growth during the last stages of decomposition, avoiding the increase in acidity caused by fungal metabolism (p432, col 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the method of bioconversion of cellulosic material into protein suitable for use as an animal feed supplement of Holliday with the mineral supplements of Sales-Campos in order to provide the necessary elements for stimulating mycelium growth, the most essential micronutrients for the growth of fungi and a favorable pH for fungus growth.
As to the claim 1 limitation that the mineral supplement have a pH of 10-13 before mixing with the wood residue, Sales-Campos discloses the addition of limestone or CaCO3 (alkalinizing mineral supplements, i.e. a pH over 7) to maintain a favorable pH and to avoid the increase in acidity caused by fungal metabolism (p432, col 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to selected an alkalinizing mineral supplement (with pH over 7) in order to avoid the increase in acidity caused by fungal metabolism. The pH range of over 7 encompasses the claimed pH of 10-13. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 I.
As to the claim limitation “wherein the first fermentation degrades lignin in the substrate composed of wood residues and releases nutrients essential for the growth and development of the fungus of the Aspergillus genus in the second fermentation”, as evidenced by Piškur, the only known organisms that can successfully decompose all structural wood components, including lignin, are white rot fungi, including Pleurotus ostreatus (p10611, RH col, para 1 and p10612, LH col, para 2). Piškur additionally discloses fermentation of wood with Pleurotus ostreatus results in an increase in iron, a nutrient essential for the growth and development of the fungus of the Aspergillus genus (p10613, Table 1).
As to the claim limitation “wherein the second fermentation converts the product obtained in 2) into the edible food product for the animal”, Sutter, in the field of using fungal strains for the production of fermented solid edible food products for animal feed, discloses the use of at least one strain of lower or filamentous fungus for the preparation of a fermented solid edible product intended for animal consumption from a by-product derived from plants. Sutter discloses the filamentous fungus can be a strain of Aspergillus sojae or Aspergillus oryzae (p2, lines 72-77). Sutter disclose the by-product derived from plants is defined as the residues or wastes from the agricultural and agrifood industries, which would include wastes from forestry (p4, lines 130-131).
Regarding claims 2 and 11, Holliday discloses wetting the cellulosic substrate and sterilizing the substrate prior to introducing the fungal microorganism [0007]-[0010], which meets the claim 2 limitation of a pre-treatment step before step 1) and the claim 11 limitation of pre-treating the wood residues prior to the first fermentation.
Holliday discloses the sterilizing agent can be a sterilant gas, which can be steam [0013]. Holliday’s disclosure of wetting the cellulosic substrate and then sterilizing with steam meets the claim limitation of heating at a temperature of at least 70oC in a wet medium.
Regarding claim 3, as indicated in the specification sawdust is sized between 1mm and 2cm and wood meal is sized between 20µm and 1mm (instant specification, p5 1st full para).
Holliday discloses the cellulosic substrate can be sawdust or wood chips [0014].
Holliday does not disclose the particles sizes or proportions of the sawdust and wood chips.
Medoff discloses a method to process a first material, biomass, to produce a second material that can be used as a substrate for the cultivation or growth of mushrooms which can then be ingested by animals [0667]. Medoff discloses the biomass can be trees, wood wastes and residues such as softwood forest thinnings, barky wastes, sawdust, wood fiber and then like [0116]. Medoff discloses the biomass feedstock is pretreated to reduce the one or more dimension of the individual pieces of biomass by grinding, cutting, smashing or crushing [0019].
Medoff discloses the size reduction can include the step of passing a first fibrous material through a first screen with an average opening size of 1.59 mm to provide a second fibrous material which is collected after passing through the screen [0134]-[0135]. Medoff’s fibrous material of less than 1.59 mm overlaps with the size range of sawdust (1mm-2cm) and encompasses the claimed size range of wood meal (20µm - 1mm). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 I.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the method of bioconversion of cellulosic material into protein suitable for use as an animal feed supplement of Holliday with the grinding of the substrate of Medoff because both Holliday and Medoff are drawn to the use of wood residue substrates for the growth of fungi (mushrooms).
Regarding the quantity of wood meal and sawdust of claim 3, Holliday in view of Sutter and Medoff does not disclose the proportions of wood meal to sawdust. However, it is known in the art that the size of the particles is a result effective variable, the smaller the particles the higher the fungus to substrate surface area ratio and the faster the fungus is able to ferment the substrate. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. Additionally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05 II A. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the method disclosed by the prior art by normal optimization procedures known in the art.
Regarding claim 13, Holliday in view of Sutter, Medoff and Sales-Campos discloses the method of claim 1 as detailed above.
Sutter further discloses the method can further comprise a drying step which has the effect of stabilizing the molecules of interest produced or released during the fermentation (p7, lines 283-286).
Regarding claim 7, Holliday discloses combining a cellulosic substrate with one or more desired fungal microorganisms and allowing the fungal microorganisms to achieve a desired level of bioconversion of the substrate (fermentation) to produce fungal mass and proteinaceous material suitable as animal feed [0007]-[0012]. Holliday’s animal feed obtained by the bioconversion of the substrate by a fungal microorganism (fermentation) meets the claim limitation of “a fermented food product.”
The claim language “obtainable by the method according to claim 1” is considered a product by process claim limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113 I. Additionally, 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. MPEP 2112.01 I.
Regardless, Holliday in combination with Sutter, Medoff and Sales-Campos as evidenced by Piškur teach the method as the set forth above with regard to claim 1. They disclose the product of the fermentation method is used as an animal feed product: Holliday [0001] and [0014], Sutter (p2, lines 72-77) and Medoff, [0667]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the method of Holliday in view of Sutter, Medoff and Sales-Campos as evidenced by Piškur, as detailed in the claim 1 rejection above, to produce a fermented food product.
Regarding claim 8, Holliday in view of Sutter, Medoff and Sales-Campos as evidenced by Piškur discloses the food product of claim 7 and the method of producing the food product of claim 1.
Holliday in view of Sutter and Medoff does not explicitly disclose the final composition of the food product in terms of enzymes, vitamins, amino acids and lignin. However, 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. MPEP 2112.01 I. Therefore, the product produced by the method of Holliday in view of Sutter, Medoff and Sales-Campos as evidenced by Piškur as detailed in the claim 1 rejection above, is considered to comprise the recited quantities of enzymes, vitamins, amino acids and lignin since it is produced by the claimed method.
Regarding claim 9, Holliday in view of Sutter, Medoff and Sales-Campos as evidenced by Piškur discloses the food product of claim 7 as described above.
Holliday further discloses the animal feed produced by the invention can be used as a food additive [0045]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined Holliday’s food additive for animal feed with an animal food ration provided to an animal since that is the intended use of Holliday’s product.
Regarding claim 10, Holliday discloses the animal can be a farm animal such as a pig, chickens, duck geese, turkeys (monogastric animals) [0046].
Response to Arguments
Applicant's arguments filed 01 June 2026 have been fully considered. To the extent they apply to the above rejection they are not persuasive.
Applicant argues the instant application is drawn to a sequential fermentation where the first fungal metabolism of the substrate creates a nutrient environment enabling the second fungal fermentation. Applicant argues that the treatment of wood residues by the first fermentation according to the invention allows the growth and the development of a second fungus of the Aspergillus genus on a substrate on which it cannot normally be grown. The subject matter encompassed by the present claims pertain to a staged or "sequential" fermentation process in which a first lignin-degrading fungus biochemically conditions the substrate and produces nutrients necessary or preferentially useful for a second fermentation fungus that produces the final animal feed product from the substrate. Remarks pp9-11.
This argument is not persuasive. As to the order of the claimed method steps, Holliday in view of Sutter, Medoff and Sales-Campos does not disclose the same order of method steps as recited in the instant claims. However, selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. MPEP 2144.04 IV. C. Applicant provides data on pp18-21 of the specification which refers to a process where the substrate is oak sawdust, the fungus of the first fermentation is Pleurotus ostreatus and the fungus of the second fermentation is Aspergillus oryzae while the instant claims are drawn to generally wood residues as substrates, and the fungus of the first fermentation is only required to be any wood destroying and edible and the fungus of the second fermentation is required to be of the genus Aspergillus. Applicant has not shown that the broader, instantly claimed limitations are required for Aspergillus oryzae to grow during a second fermentation.
The data provided to show unexpected results is not commensurate in scope with the instantly claimed method. The claims recite no extent of fermentation by the fungi nor quantity of wood residue versus fungi. The claims recite a method for step 1) combining any amount of wood residue with any amount of wood destroying edible fungi for “a suitable duration corresponding to the maximum colonization of the substrate before fructification by said fungus.” The broadest reasonable interpretation of this claim includes scenarios where only a small amount of the wood residue is fermented by the fungus in step 1. Therefore at the end of step 1) a significant amount of wood residue remains. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have elected to combine the fermentation of Holliday with a second fermentation step disclosed by Sutter in order to ferment the wood residues remaining after the fermentation of Holliday and maximize the conversion of the wood residues into useable animal feed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. 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 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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/C.L.G./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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