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 .
DETAILED ACTION
2. Applicants’ arguments and amendments filed on 6/2/2025, overcomes the rejections of record. However, examiner has considered an additional 112 rejections (112 a and b) which is not due to the amendment of claims 1, 29. Therefore, the new grounds of rejection as set forth below is made as non-final.
Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn.
Status of the application
3. Claims 1-7, 10-15, 17-28, 29-35 are pending in this office action.
Claims 1, 29 have been amended.
Claims 1-7, 10-15, and 17-35 will be considered as withdrawn due to restriction as discussed above.
Claim Rejections - 35 USC § 112
4. 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
5. Claims 1-35 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claims 1, 29 recite “cohesive mycelial biomass”. However, there is no support in the specification for this phrase. In specification, it recites “cohesive filamentus biomat” (in PGPUB [0015], [0066], [0072],
Claim Rejections - 35 USC § 112
6. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claims 1-35 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Independent claims 1, 29 recite “cohesive mycelial biomass”. Also, since fungi may produce and retain microstructure integrity of the biomats (in PGPUB [0146]) which is a complex network as revealed by FE-SEM (in PGPUB [0147]), therefore, cohesive biomat (interwoven mycelia) when grown in submerged culture, it is not clear whether claims 1, 29 are directed to a surface grown or submerged fungal culture.
Claim Rejections - 35 USC § 103
8. 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.
9. 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.
10. 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.
11. Claims 1-4, 7, 10- 15, 17-35 are rejected under 35 U.S.C. 103 as being unpatentable over Kozubal et al. US 2016/0002680 A1 in view of Porter et al. (US 6,991,919) and further in view of NPL Gibbs et al. (Critical Rev. in biotechnology 20 (1): 17-48, 2000) in view of John et al. (KR 20130055597 A) and as evidenced by Kozubal et al. (US 2021/0155893 A1) (Hereinafter Kozubal et al.’893).
12. Regarding claims1-4, 7, 10- 15, 17-35 , Kozubal et al. discloses the method of growing strain and biomat cultures of MK 7 using substantially similar medium, conditions and substrates as used in the specification in order to produce one or more useful products using cellulosic waste products which supports the growth of filamentous fungus (at least in [0018], [0024], [0030] e.g. ligno-cellulosic, agricultural waste etc. [0111], [0137], [0148] e.g. complex nutrient is agricultural residues, [0158], [0162], [0227] e.g. to grow isolated fungi, [0228] e.g. biomass accumulation, [0261]-[0266], [0270]). Kozubal et al. also discloses that the process can be performed in a bioreactor (fermenter) ([0208]) including biomass production and accumulation ([0228]) having an anaerobic contact reactor ([0208]) in a continuous method and culture medium is removed continuously (at least in [0208]) which meets claims 1, 2, 3, 11, 12, 29. Kozubal et al. also discloses that it can be culture vessel also ([0259]) to meet claim 4.
With respect to the recitation in claims 6,7,10, 14, 15, Kozubal discloses biomats prepared using the same MK7 strain under culture conditions (including substantially the same media and culture duration) as described as yielding biomats (see above). Where a claimed product and a prior art product are produced by identical or substantially identical processes, a prima facie case of inherency has been established and the burden shifts to Applicant to establish that the properties of the claimed product differ from the prior art (see MPEP 2112.01).
However, it is within the skill of one of ordinary skill I the art to optimize the condition in a way so that the claimed “dry biomass per sq meter..” as claimed in claim 6, “total biomass yield..” as claimed in claim 7, and “rate of constant production” as claimed in claim 10 are optimizable.
Absent showing of unexpected results, the specific amount of constant production of “total biomass yield” in terms of per sq meter, is not considered to confer patentability to the claims. As the (fermentation conditions are variables that can be modified, among others, by adjusting the growth conditions e.g. time of growth etc., the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of constant production of “total biomass yield” in terms of per sq meter, in Kozubal et al, to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired total biomass yield (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
It is to be noted that and as mentioned above that Kozubal discloses biomats prepared using the same MK7 strain under culture conditions (including substantially the same media and culture duration) as described as yielding biomats (see above). Where a claimed product and a prior art product are produced by identical or substantially identical processes, a prima facie case of inherency has been established and the burden shifts to Applicant to establish that the properties of the claimed product differ from the prior art (see MPEP 2112.01).
Additionally, more specifically, Kozubal et al. is silent about the sequential steps of independent claims 1 and 29.
Porter et al. discloses an apparatus and method for cultivating fungi wherein the organism is placed on a membrane in contact with a medium. Porter et al. also discloses a container comprising the culture medium (at least in Fig 1 and claim 1 of Porter et al.). The membrane is placed on a support and in contact with the liquid medium. The container has a lid through which oxygen may be supplied to the growing organisms. Carbon dioxide may exit through the lid membrane (Fig. 1). Porter et al. discloses that the membrane used in constructed of a polypropylene sheet with a pore size of 0.3 micron. The membrane is welded to the frame (Support) and has been treated to make it water permeable. (col. 5, lines 20-45).
Regarding “cohesive biomass”, it is known and as also evidenced by Kozubal et al. ‘893 that the densely grown mycelial biomass (biomat) is cohesive biomass upon drying (at least in [0101]). It is within the skill of one of ordinary skill in the art to optimize the condition in a way so that “culturing the filamentous fungus can form dense population of mycelial biomass which is “cohesive biomass” of claim 29 (b) using the apparatus of Porter et al.
Absent any evidence to the contrary and based on the teachings of the cited references, there would have been a reasonable expectation of success in producing more fungal biomass in dense form with in the culture systems in a cost-effective manner.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Kozubal et al. with the teaching of the method and apparatus setting of Porter et al. to form cohesive biomass of filamentous fungus.
Regarding claims 1 (c), 29 (c), Kozubal et al. in view of Porter et al. is silent about “refreshing the fermentation medium with a second aliquot of the fermentation medium” as claimed in amended claims 1 (c), 29 (c).
NPL Gibbs et al. discloses that medium composition is a strong determinant for the hyphal morphology (V. Hyphal Morphology” page 21, col 2 last paragraph, page 22 col 1, first paragraph) and growth of microorganisms which is altered with respect to the viscosity, nutrients amounts with time when used to culture any microorganism for a certain time and altered pH etc. (at least on page 30 under C. “Medium Composition”) which makes the environment not suitable for further growth to make more biomass production. Therefore, one of ordinary skill in the art would have been motivated with reasonable expectation of success to consider “refreshed fermentation medium” “with a second aliquot of the fermentation medium” which is identical to the fermentation medium used as “first aliquot” at step of claim 1 (a), 29 (a).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Kozubal et al. in view of Porter et al. to include the teaching of NPL Gibbs et al. to consider refreshed fermentation medium” “with a second aliquot of the fermentation medium” which is identical to the fermentation medium used as “first aliquot” in order to have further healthy growth of the filamentous fungi with more dense biomass (fungal mat) with the maintenances of good hyphal morphology and overall good health of the fungal biomass.
It is also to be noted that absent any evidence to the contrary and based on the teachings of the cited references, there would have been a reasonable expectation of success to culture “the cohesive biomass” further by replacing the medium with refreshed medium as disclosed by Porter et al. to supply more nutrients to the densely grown mycelial biomass (i.e., bio-mat) for healthy cohesive biomass production to meet claims 1(d), 29 (d).
One of ordinary skill in the art, at the time the invention was made, would have been motivated to modify Nord et al. by replacing the medium with refreshed medium as disclosed by Porter et al. to supply more nutrients to the densely grown mycelial biomass (i.e., bio-mat) for healthy cohesive biomass production.
Regarding step of claims 1(e), 29 (e), the membrane surface liquid culture systems of Porter et al. would have been employed to produce fungal biomass after sufficient growth in the form of mats (fungal mats), by modifying Kozubal et al. and followed washed, air dried and ground into a powder as disclosed by Kozubal et al. (Example 1). Therefore, modified Kozubal et al. modified by Porter et al. and NPL Gibbs et al. meet claims 1, 29.
One of ordinary skill in the art would have been motivated to recover a portion of the cohesive biomass from a mature end in order to create more open area to allow new biomat growth without starting from beginning inoculation step. In addition, after the isolation and collection of cohesive biomasses (/biomat), it is further deactivated for its further use.
Kozubal et al. in view of Porter et al. and further in view of NPL Gibbs et al. are specifically silent about the step of “inactivating the recovered biomass” as claimed in amended claim 1.
John et al. discloses that such algal biomass as algal flour comprising high protein and lipid (at least in pages 21, fifth paragraph, page 22 second paragraph page 25) can be made recovered by inactivating biomass (page 26 contd to page 27, e.g. under Section III, paragraph 3, “mostly lyzed cells” and Under IIIA. “Algae powder”) and is used as food or in food composition for human consumption (page 6 under “Detailed Description of the invention). Therefore, recovery includes by inactivating the biomass to be used as the source of protein and lipid to meet claims 1(e), (f), and claim 29 (e).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Kozubal et al. to include the teaching of John et al. to use algal biomass as algal flour as a source of high protein and lipid (at least in pages 21, fifth paragraph, page 22 second paragraph page 25) can be made by inactivating recovered biomass (page 26 contd to page 27, e.g. under Section III, paragraph 3, “mostly lyzed cells” and Under IIIA. “Algae powder”) in order to use as food or in food composition for human consumption (page 6 under “Detailed Description of the invention).
13. Regarding claim 17, it is to be noted that the claimed step of refreshing daily is optimizable. It is within the skill of one of ordinary skill in the art to optimize the condition in a way so that the best quality and amount of biomat can be produced which includes “refreshing” daily with new medium to provide necessary optimum amounts of nutrients from the medium as food material to have mycelial growth properly.
As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, refreshing” daily with new medium to provide necessary optimum amounts of nutrients from the medium as food material to have mycelial growth properly, to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired total biomass yield with good quality and quantity (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
14. Regarding claim 18 has synthetic agar media ([0296]). It is to be noted that and as it is known to one of ordinary skill in the art that the media is common for liquid and solid media with the exception that the solid media is made with an additional addition of solidifying agent e.g. agar. Therefore, as other ingredients are common, therefore, the liquid media can be made as synthetic media without agar. Therefore, it meets “synthetic media”.
15. Claim 24, Kozubal et al. discloses the method of growing strain and biomat cultures of MK 7 using substantially similar medium, conditions and substrates as used in the specification in order to produce one or more useful products using cellulosic waste products which supports the growth of filamentous fungus (at least in [0018], [0024], [0030] e.g. ligno-cellulosic, agricultural waste etc. [0111], [0137], [0148] e.g. complex nutrient is agricultural residues, [0158], [0162], [0227] e.g. to grow isolated fungi, [0228] e.g. biomass accumulation, [0261]-[0266], [0270]). Kozubal discloses biomats prepared using the same MK7 strain under culture conditions (including substantially the same media and culture duration) as described as yielding biomats (see above). Where a claimed product and a prior art product are produced by identical or substantially identical processes, a prima facie case of inherency has been established and the burden shifts to Applicant to establish that the properties of the claimed product differ from the prior art (see MPEP 2112.01).
16. Regarding claims 25-27, Kozubal et al. also discloses that the process can be performed in a bioreactor (fermentor) (at least in [0208]) including biomass production, accumulation and lipid production (at least in [0228]).
17. Regarding claim 28, Kozubal et al. also discloses that the lipid can be extracted by different procedures including solvent extraction method (at least in [0225] e.g. see at least Hara et al. reference as cited in [0225] and [e.g. mechanical process).
18. Regarding claims 1-7, 10-15, and 17-35, it is to be noted that and as mentioned above that Kozubal discloses biomats prepared using the same MK7 strain under culture conditions (including substantially the same media and culture duration) as described as yielding biomats (see above). Where a claimed product and a prior art product are produced by identical or substantially identical processes, a prima facie case of inherency has been established and the burden shifts to Applicant to establish that the properties of the claimed product differ from the prior art (see MPEP 2112.01).
19. Claims 29-33, 35 are rejected under 35 U.S.C. 103 as being unpatentable over Nord (US 2,450,055) in view of Porter et al. (US 6,991,919) in view of NPL Gibbs et al. (Critical Rev. in biotechnology 20 (1): 17-48, 2000) and as evidenced by Kozubal et al. (US 2021/0155893 A1).
20. Regarding claim 29, Nord et al. discloses a method for growing Fusarium lini on liquid medium to meet claim 29 (a). After sufficient growth in the form of mats (fungal mats), the mats are removed, washed, air dried and ground into a powder. (Example 1).
Nord et al. is silent to sequential steps of claim 29.
Porter et al. discloses an apparatus and method for cultivating fungi wherein the organism is placed on a membrane in contact with a medium. Porter et al. also discloses a container comprising the culture medium (at least in Fig 1 and claim 1 of Porter et al.). The membrane is placed on a support and in contact with the liquid medium. The container has a lid through which oxygen may be supplied to the growing organisms. Carbon dioxide may exit through the lid membrane (Fig. 1). Porter et al. discloses that the membrane used in constructed of a polypropylene sheet with a pore size of 0.3 micron. The membrane is welded to the frame (Support) and has been treated to make it water permeable. (col. 5, lines 20-45).
Regarding “cohesive biomass”, it is known and as also evidenced by Kozubal et al. ‘893 that the densely grown mycelial biomass (biomat) is cohesive biomass upon drying (at least in [0101]). Porter et al. discloses the method of using a membrane surface liquid culture (MSLC) to grow fungal mycelia in the form of a mat (fungal mat). The membrane surface liquid culture systems of Porter et al. would have been employed to produce fungal biomass. It is within the skill of one of ordinary skill in the art to optimize the condition in a way so that “culturing the filamentous fungus can form dense population of mycelial biomass which is “cohesive biomass” of claim 29 (b) using the apparatus and method of Porter et al.
Absent any evidence to the contrary and based on the teachings of the cited references, there would have been a reasonable expectation of success in producing more fungal biomass in dense form with in the culture systems in a cost-effective manner.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Nord et al. with the teaching of the method and apparatus setting of Porter et al. to form cohesive biomass of filamentous fungus.
Regarding claim 29 (c), Nord et al. in view of Porter et al. is silent about “refreshing the fermentation medium with a second aliquot of the fermentation medium” as claimed in amended claim 29 (c).
NPL Gibbs et al. discloses that medium composition is a strong determinant for the hyphal morphology (V. Hyphal Morphology” page 21, col 2 last paragraph, page 22 col 1, first paragraph) and growth of microorganisms which is altered with respect to the viscosity, nutrients amounts with time when used to culture any microorganism for a certain time and altered pH etc. (at least on page 30 under C. “Medium Composition”) which makes the environment not suitable for further growth to make more biomass production. Therefore, one of ordinary skill in the art would have been motivated with reasonable expectation of success to consider “refreshed fermentation medium” “with a second aliquot of the fermentation medium” which is identical to the fermentation medium used as “first aliquot” at step 29 (a).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Nord et al. in view of Porter et al. to include the teaching of NPL Gibbs et al. to consider refreshed fermentation medium” “with a second aliquot of the fermentation medium” which is identical to the fermentation medium used as “first aliquot” in order to have further healthy growth of the filamentous fungi with more dense biomass (fungal mat) with the maintenances of good hyphal morphology and overall good health of the fungal biomass.
It is also to be noted that absent any evidence to the contrary and based on the teachings of the cited references, there would have been a reasonable expectation of success to culture “the cohesive biomass” further by replacing the medium with refreshed medium as disclosed by Porter et al. to supply more nutrients to the densely grown mycelial biomass (i.e., bio-mat) for healthy cohesive biomass production to meet claim 29 (d).
Therefore, Nord et al. in view of Porter et al. and NPL Gibbs et al. reads on “refreshing at least a portion of the fermentation medium” as claimed in claim 29 (c) and also “culturing the cohesive biomass using the refreshed fermentation medium” as claimed in claim 29 (d).
Absent any evidence to the contrary and based on the teachings of the cited references, there would have been a reasonable expectation of success to culture “the cohesive biomass” further by replacing the medium with refreshed medium as disclosed by Porter et al. to supply more nutrients to the densely grown mycelial biomass (i.e., bio-mat) for healthy cohesive biomass production to meet claim 29 (d).
One of ordinary skill in the art, at the time the invention was made, would have been motivated to modify Nord et al. by replacing the medium with refreshed medium as disclosed by Porter et al. to supply more nutrients to the densely grown mycelial biomass (i.e., bio-mat) for healthy cohesive biomass production.
Regarding step of claim 29 (e), the membrane surface liquid culture systems of Porter et al. would have been employed to produce fungal biomass after sufficient growth in the form of mats (fungal mats), by modifying Nord et al. and followed washed, air dried and ground into a powder as disclosed by Nord et al. (Example 1). Therefore, modified Nord et al., modified by Porter et al., meet claim 29. one of ordinary skill in the art would have been motivated to recover a portion of the cohesive biomass from a mature end in order to create more open area to allow new biomat growth without starting from beginning inoculation step.
21. Regarding claim 30, Nord et al. discloses that Fusarium lini is grown and dried mycelial are made (col 3 lines 43-45) which is the source of protein and vitamin B-complex (at least in claim 6 of Nord et al.).
22. Regarding claim 31, 32, claim 31 recites “wherein a biomass production rate is at least about 40 grams dry biomass per square meter of the surface of the fermentation medium per day” and claim 32 recites “wherein a total biomass yield is about 2.5 kilograms dry biomass per square meter of the surface of the fermentation medium”. Therefore, the claim limitations of claims 31 and 32 is based on the “biomass yield” which depends on the nature of densed cohesive biomass production. As discussed above, it depends on the many factors of culturing and growing to recover the final biomass using steps of claim 29. Many factors include, time of growing in a fermentation medium, area of culturing, culture media (e.g., Nord et al. discloses that vitamin B1 in the culture media increases thiamin content, at least in col 3 lines 2-5) etc. Therefore, it is optimizable.
Absent showing of unexpected results, the specific amount of “dry biomass” is not considered to confer patentability to the claims. As the “biomass production rate is at least about 40 grams dry biomass per square meter of the surface of the fermentation medium per day” as claimed in claim 31 and “ wherein a total biomass yield is about 2.5 kilograms dry biomass per square meter of the surface of the fermentation medium” as claimed in claim 32 (i.e. claimed Biomass yield of claims 31, 32) are variables that can be modified, among others, by adjusting the culturing conditions e.g. time of growing in a fermentation medium, area of culturing, culture media (e.g. Nord et al. discloses that vitamin B1 in the culture media increases thiamin content, at least in col 3 lines 2-5) etc., the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of “biomass yield” in Nord et al. in view of Porter et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g., desired “Biomass yield” (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
23. Regarding claim 33, it is to be noted that it is within the skill of one of ordinary skill in the art and one of ordinary skill in the art would have been motivated to recover a portion of the cohesive biomass from a mature end in order to create more open area to allow new biomat growth without starting from beginning inoculation step.
24. Regarding claim 35, Porter et al. discloses an apparatus and method for cultivating fungi wherein the organism is placed on a membrane in contact with a medium. Porter et al. also discloses a container comprising the culture medium (at least in Fig 1 and claim 1 of Porter et al.). It is known to one of ordinary skill in the art a commonly used container is tray. Therefore, the container can be a tray also.
25. Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Nord (US 2,450,055) in view of Porter et al. (US 6,991,919) in view of NPL Gibbs et al. and as evidenced by Kozubal et al. (US 2021/0155893 A1) (hereinafter Kobuzal et al. ‘893) as applied to claim 29 and further in view of Kelly et al. (US 2014 /0065263).
26. Regarding claim 34, Nord in view of Porter et al. is silent about claimed filamentous fungi as claimed in claim 34. Kelly et al. also discloses that the fungal mycelia which is of the phylum Basidiomycota belongs to Ganoderma lucidum or Grifola frondose (at least in Abstract, [0034]) to meet claim 34. Kelly et al. also discloses that different filamentous fungus has different medicinal and nutritional values ([0008]- [0013]) and, for example, Gonaderma lucidum is anti-inflammatory, anti-oxidant, anti-histamine, anti-cancer effect ([0011]).
It is to be noted that the method of production of desired filamentous fungus of desired choice can be made and within the skill of one of ordinary skill in the art by using the disclosed method of Nord et al. in view of Porter et al. One of ordinary skill in the art would have been motivated to consider desired filamentous fungus as preferred choice based on its specific nutritional and health benefit ([0008]- [0013]) with reasonable expectation of success.
One of ordinary skill in the art, at the time the invention was made, would have been motivated to use the method of Nord et al. in view of Porter et al. by modifying filamentous fungus of Nord et al. in view of Porter et al. to include desired filamentous fungus as desired preferred choice based on its specific nutritional and health benefit ([0008]- [0013]).
27. Claims 29, 30, 33, 34 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al. (US 2014 /0065263) in view of Porter et al. (US 6,991,919) and further in view of NPL Gibbs et al. (Critical Rev. in biotechnology 20 (1): 17-48, 2000) and as evidenced by Kozubal et al. (US 2021/0155893 A1).
28. Kelly et al. discloses a food material comprising myceliated agricultural substrate which can include is from filamentous fungus Basidiomycota to produce functional foods with health benefits (at least in Abstract, [0042], [0043]).
29. Regarding claims 29, 34, Kelly et al. discloses a food material comprising myceliated agricultural substrate which can include is from filamentous fungus Basidiomycota to produce functional foods with health benefits (at least in Abstract, [0042], [0043]). Kelly et al. also discloses that the mycelial samples are grown in a sterile airflow, and culture grows very quickly as hyphal spheres, (at least in Example 1) or on cocoa bean and toasted (i.e., non-viable) (at least in Examples 1,2, 5) to meet claim 29. Kelly et al. also discloses that the fungal mycelia which is of the phylum Basidiomycota belongs to Ganoderma lucidum or Grifola frondose (at least in Abstract, [0034]) to meet claims 29, 34.
Kelly et al. is silent to sequential steps of claim 29.
Porter et al. discloses an apparatus and method for cultivating fungi wherein the organism is placed on a membrane in contact with a medium. Porter et al. also discloses a container comprising the culture medium (at least in Fig 1 and claim 1 of Porter et al.). The membrane is placed on a support and in contact with the liquid medium. The container has a lid through which oxygen may be supplied to the growing organisms. Carbon dioxide may exit through the lid membrane (Fig. 1). Porter et al. discloses that the membrane used in constructed of a polypropylene sheet with a pore size of 0.3 micron. The membrane is welded to the frame (Support) and has been treated to make it water permeable. (col. 5, lines 20-45).
Regarding “cohesive biomass”, it is known and as also evidenced by Kozubal et al.’893 that the densely grown mycelial biomass (biomat) is cohesive biomass upon drying (at least in [0101]). It is within the skill of one of ordinary skill in the art to optimize the condition in a way so that “culturing the filamentous fungus can form dense population of mycelial biomass which is “cohesive biomass” of claim 29 (b) using the apparatus of Porter et al.
Absent any evidence to the contrary and based on the teachings of the cited references, there would have been a reasonable expectation of success in producing more fungal biomass in dense form with in the culture systems in a cost-effective manner.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Kelly et al. with the teaching of the method and apparatus setting of Porter et al. to form cohesive biomass of filamentous fungus.
Regarding claim 29 (c), Kelly et al. in view of Porter et al. is silent about “refreshing the fermentation medium with a second aliquot of the fermentation medium” as claimed in amended claim 29 (c).
NPL Gibbs et al. discloses that medium composition is a strong determinant for the hyphal morphology (V. Hyphal Morphology” page 21, col 2 last paragraph, page 22 col 1, first paragraph) and growth of microorganisms which is altered with respect to the viscosity, nutrients amounts with time when used to culture any microorganism for a certain time and altered pH etc. (at least on page 30 under C. “Medium Composition”) which makes the environment not suitable for further growth to make more biomass production. Therefore, one of ordinary skill in the art would have been motivated with reasonable expectation of success to consider “refreshed fermentation medium” “with a second aliquot of the fermentation medium” which is identical to the fermentation medium used as “first aliquot” at step 29 (a).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Kelly et al. in view of Porter et al. to include the teaching of NPL Gibbs et al. to consider refreshed fermentation medium” “with a second aliquot of the fermentation medium” which is identical to the fermentation medium used as “first aliquot” in order to have further healthy growth of the filamentous fungi with more dense biomass (fungal mat) with the maintenances of good hyphal morphology and overall good health of the fungal biomass.
It is also to be noted that absent any evidence to the contrary and based on the teachings of the cited references, there would have been a reasonable expectation of success to culture “the cohesive biomass” further by replacing the medium with refreshed medium as disclosed by Porter et al. to supply more nutrients to the densely grown mycelial biomass (i.e., bio-mat) for healthy cohesive biomass production to meet claim 29 (d).
One of ordinary skill in the art, at the time the invention was made, would have been motivated to modify Nord et al. by replacing the medium with refreshed medium as disclosed by Porter et al. to supply more nutrients to the densely grown mycelial biomass (i.e., bio-mat) for healthy cohesive biomass production.
Regarding step of claim 29 (e), the membrane surface liquid culture systems of Porter et al. would have been employed to produce fungal biomass after sufficient growth in the form of mats (fungal mats), by modifying Kelly et al. and followed washed, air dried and ground into a powder as disclosed by Kelly et al. (Example 1). Therefore, modified Kelly et al., modified by Porter et al. and NPL Gibbs et al. meet claim 29. one of ordinary skill in the art would have been motivated to recover a portion of the cohesive biomass from a mature end in order to create more open area to allow new biomat growth without starting from beginning inoculation step.
30. Regarding claim 30, Kelly et al. discloses the method of myceliation of agricultural product for producing functional foods which can include is from filamentous fungus Basidiomycota to produce functional foods with health benefits (at least in Abstract, [0042], [0043]). Therefore, it meets “mycelia” of claim 30.
31. Regarding claim 33, it is to be noted that it is within the skill of one of ordinary skill in the art and one of ordinary skill in the art would have been motivated to recover a portion of the cohesive biomass from a mature end in order to create more open area to allow new biomat growth without starting from beginning inoculation step.
Pertinent prior art (Notes)
32. Hogan et al. USPN 4731248.
Hogan et al. discloses that fungal mycelial biomass can be inactivated to be used as edible material as food or in food composition (at least in col 1, 40-56; col 2 lines 30-65, col 5 lines 29-45). It is to be noted that although col 1, lines 40-56 is under “Backgound” section, however, dependeing on the type of heat inactivated fungal biomass, it can be used as food for human (col 1, 40-56) and for animal (pet) food (col 2 lines 22-25, 30-65 and col 5 lines 29-45).
Response to arguments
33. Amendment of claim 1 overcome statutory DP. ODP is not made as TD submitted (6/3/2024).
34. Applicants argued on 3rd page, in particular, fourth paragraph that “Porter discloses induced production of secondary metabolites by exhausting nutrients within the growth medium (Column 1, lines 45-55). Porter relies on replacing the growth medium with a replacement medium that is deficient in specific nutrients in order to induce production of metabolites. Porter discloses that, “in order to induce secondary metabolism in a microorganism, a culture of the microorganism must be kept in an environment lacking (or having a reduced concentration in) one or more of the nutrients essential to primary metabolism” and “the growth medium selected from the lists set out above must be replaced by a nutrient deficient medium” (Column 6, lines 60-66). However, the present application describes, and one of ordinary skill in the art would understand, that refreshing the fermentation medium is necessary to replenish the nutrients in the growth medium at the rate of removal by the biomat (Specification, Ex. 4)”.
In response, in this instance, claimed invention claims “replacing the growth medium with a replacement medium” to replenish the nutrients in the growth medium for the growth of biomass whereas Porter teaches the “culturing the filamentous fungus can form dense population of mycelial biomass which is “cohesive biomass” of claim 29 (b) using the apparatus and method of Porter et al.
It is to be noted that in the disclosure by Porter et al., “A first aspect of the invention provides a biological procedure which includes arranging biomass with access to a medium (i.e. fermentation medium) said medium being suitable to support biomass growth (col 2 lines 20-24) and this is presented in Fig 1 (Col 3 lines 25-27). This is first embodiment. This is considered in the office action. Porter et al. also discloses a second embodiment which is a second aspect of the invention which provide a procedure to use this organism from the biomass generated in the first aspect (i.e. first embodiment) to make secondary metabolite as biochemical using second medium which is applicant’s alleged “nutrient deficient medium (column 6, lines 60-66) as alleged by the applicants (in Remarks, mid-section4th paragraph). It is to be noted that the disclosed second embodiment which recites ‘biochemical’ as secondary metabolite as disclosed by Porter et al. has not been used in the office action.
Applicants argued combining the teachings of first and second aspects (Embodiments) of Porter et al. The first embodiment with the disclosed method and apparatus to make ‘cohesive Biomass” as disclosed by Porter et al. is considered in the office action. Therefore, Porter is not teaching away.
Examiner did not use this alleged paragraph in the last office action.
In order to address “refreshed fermentation medium” which is specified as “with a second aliquot of the fermentation medium” as claimed in amended claim 29 (c), examiner has additionally used another secondary prior art by NPL Gibbs et al., in combination with the obviousness rejection which was made in the last office action. This new secondary prior art specifically provides motivation to include “a second aliquot of the fermentation medium” used as “first aliquot” in amended claim 29 (a) with motivation as discussed in the office action above.
It is to be noted that even if Porter et al. discloses both the biomass production and ‘biochemical’ as secondary metabolite, Porter et al. is used as secondary prior art to address the method and apparatus to make ‘fungal mat’ and ‘cohesive biomass’ morphology (i.e. first embodiment of Porter as discussed above) of the filamentous fungus by modifying primary prior art by Nord et al. Therefore, there is no conflict between first embodiment to make filamentous fungi biomass with the alleged disclosed ‘nutrient deficient medium’ to make biochemical as disclosed in the second embodiment of Porter et al. as discussed above.
It is to be noted that and as discussed in the office action above that NPL Gibbs et al. discloses that medium composition is a strong determinant for the hyphal morphology (V. Hyphal Morphology” page 21, col 2 last paragraph, page 22 col 1, first paragraph) and growth of microorganisms which is altered with respect to the viscosity, nutrients amounts with time when used to culture any microorganism for a certain time and altered pH etc. (at least on page 30 under C. “Medium Composition”) which makes the environment not suitable for further growth to make more biomass production. This is discussed in the office action above.
Claim 35 was also rejected using Porter et al. in the last office action and maintained in this office action. Examiner maintained prior office action with portal et al. and added new secondary prior art by NPL Gibbs et al. to address amended claim 29.
35. Applicants argued on 3rd page last paragraph that “Nord in view of Porter” and on 4th page that “Kelly et al. in view of Porter et al.” fails to address amended claim 29 (c).
In response, that is why examiner has considered a new secondary prior art by NPL Gibbs et al.
Applicants do not have any further arguments.
The new secondary prior art by Gibbs et al. has been considered to address the amendment of claim 29. Therefore, the rejection is made as final.
Conclusion
36. Any inquiry concerning the communication or earlier communications from the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful, examiner’s supervisor Erik Kashnikow, can be reached on 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792