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 21-42 are pending (claim set as filed on 12/04/2025).
Election/Restrictions
Applicant’s election without traverse of Group I, method claims, in the reply filed on 12/04/2025 is acknowledged.
Claim 42, drawn to the apparatus, is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Therefore, only method claims 21-41 are under examination.
Priority
This application is a CON of application no. 17/293,413 which is a CON of application no. 16/688,699 (now abandoned), which is a 371 of PCT/US2019/062248 filed on 11/19/2019, and has provisional applications to: 62/769,789 and 16/688,699 filed on 11/20/2018.
Drawings
The drawings filed on 06/27/2023 have been accepted.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 10/20/2023 and 12/17/2024 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the Examiner.
Claim Objections
Claim 27 is objected to because it lacks a period to conclude the sentence.
Claim Rejections - 35 USC §112, Indefinite
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.
Claim 36 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 36, the phrase “such as” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention (MPEP 2173.05(d): Exemplary Claim Language).
Claim Rejections - 35 USC §103, Obviousness
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 21-26, 34, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over McIntyre (US 2012/0227899 A1 - citation #214 of page 8 in the IDS filed on 10/20/2023) in view of Minty (WO 2017/205750 - citation #372 of page 14 in the IDS filed on 10/20/2023).
McIntyre’s general disclosure relates to a method of producing a chitinous polymer derived from fungal growth (see abstract ¶ [0002]).
McIntyre discloses a method of generating a mycelial scaffold (a solid polymer matrix formed using mycelium (mycelial scaffold)) comprising the steps of inoculating a filamentous organism into a medium containing nutrition for cultivation and growth of said organism (a culture of a filamentous fungus is inoculated into a nutrient broth culture medium, which would necessarily support cultivation and growth of said organism), and incubating said inoculated medium in a defined environment for a time sufficient for the growth of a mycological biopolymer growth from said medium (a culture of a filamentous fungus is inoculated into a nutrient broth culture medium and incubated for five to nine days (time sufficient for growth) in 90% relative humidity and 86°F (a defined environment in claim 34), which results in formation of a chitinous mycological polymer, without producing a stipe, cap or spore therein (the reference does not teach producing a stipe, cap or spore therein, as such the mycological biopolymer is considered to not produce a stipe, cap or spore) characterized in that the fungus is a biocompatible species (the fungus forms a biomaterial polymer matrix, thereby indicating that the fungus is a biocompatible species (see ¶[0006]-[0007], [0075]) and in removing the growth of mycological biopolymer from said medium as a one piece self-contained scaffold (incubating the mycelium to induce mycelium cohesion and to form a solid mycological polymer, which is dried and recovered from the medium as a single sheet (a self-contained scaffold) (see abstract & Example 1 at ¶ [0044]-[0060]).
Regarding claims 22-25 pertaining to modifying conditions, McIntyre further discloses wherein said medium is a liquid medium in a bioreactor vessel (a bioreactor vessel is filled with warm media that has not solidified (see ¶ [0083]) and further characterized in incubating said inoculated medium at a rate of inoculation to target specific resultant filamentous pellets sizes optimized for downstream texture and cell adhesion to support growth (the nutrient medium is inoculated with filamentous fungi under specified time and growth conditions, and extracted mycelium is processed to achieve a uniform size (specific resultant pellet sizes), and incubated to induce mycelium cohesion (cell adhesion to support growth) and result in a uniform solid, such as mycelium pellets with specific physiology of fungal tissue (downstream texture) (see ¶ [0008]-[0010], [0025], [0050]); maintaining a viscosity of said inoculated liquid medium (growth environment is modulated by changing (and eventually maintaining) the fluid viscosity of liquid suspension culture (see ¶ [0015]-[0017]) at a degree sufficient to maintain dissolved oxygen for filamentous organism cultivation into a filamentous network (the broth with inoculated filamentous fungi is aerated, and dissolved gas concentration (dissolved oxygen) and viscosity are modulated (and eventually maintained) to control the quantity and type of mycelium cultivated into a polymer (filamentous network) (see ¶ [0017], [0044], [0049], [0051], [0066]); and stirring said inoculated medium at a degree sufficient to affect expression of a specific three-dimensional filamentous pellet morphology from said filamentous network (the broth with inoculated filamentous fungi is agitated with a magnetic stir rod, following which (at a degree sufficient to affect) the mycelium grows (expression) into a polymer (filamentous network) and acquires a net geometry and can be processed into three-dimensional pellets (see ¶ [0021]-[0022], [0044], [0049], [0051], [0066]).
McIntyre further discloses characterized in the step of applying said inoculated medium to a surface of a preformed element in a drip-wise manner (the gelatinous medium containing the inoculated fungi and separated mycelium is molded into an enclosure through a peristaltic pump at flow rate of 50 mL per minute (drip-wise manner) (see ¶ [0010], [0058]) for a time sufficient for a mycelia sheet to form on said surface prior to removing said mycelial sheet from said element as a one-piece self-contained scaffold (mycelium sheets are formed over a buck or negative form, and then dried on the tools (time sufficient for a mycelia sheet to form) to grant form, and then ejected from the form, intrinsically as a one piece self-contained scaffold (see ¶ [0010], [0057]).
McIntyre further discloses wherein said medium is in a bioreactor vessel (liquid medium is pumped into a bioreactor vessel (see ¶ [0083]) and further characterized in incubating said medium in said vessel for a time and under conditions sufficient to affect expression of a specific three-dimensional filamentous network morphology external to said medium (the broth with inoculated filamentous fungi is incubated for a suitable amount of time and under specified temperature and humidity conditions, following which the mycelium grows (expression) into a polymer (filamentous network) and acquires a net geometry and can be extracted (external to medium) and processed into three-dimensional pellets (see ¶ [0021]-[0022], [0044], [0049]-[0051], [0066]); and depositing at least one layer of a selected material onto said filamentous network morphology during expression of said filamentous network morphology to impart predetermined characteristics to said filamentous; network morphology prior to removing said filamentous network morphology as a one piece self-contained scaffold (a supplemental material (selected material) can be used along with the scaffold that may intrinsically form a layer on the filamentous scaffold, and provide additional nutrition or strengthen the scaffold (impart predetermined characteristics), thereby indicating that the supplemental material layer is deposited during expression of filamentous network morphology, following which the mycelium pellets are extracted from the broth (prior to removing one-piece self-contained scaffold) (see ¶[0010], [0021], [0049], [0051], [0064], [0066]).
McIntyre further discloses characterized in patterning said filamentous network morphology with a predetermined shape after removal from said vessel (extracted (removal from vessel) mycelium which is in the form of a mycological polymer (filamentous network morphology) is injection molded or compressed into various incubation enclosures to obtain various morphologies (patterning with a predetermined shape) (see ¶ [0008]- [0010]). The mycelium sheet 27 may be cut by a suitable stylus 28 to form cutouts 29 of predetermined shape or shapes (see ¶ [0036], [0072], wherein the stacked shapes form a billet of claim 41).
McIntyre further discloses characterized in introducing a secondary biocompatible material into said scaffold to impart a desired characteristic to said scaffold (a secondary gelling agent, such as agar (biocompatible material), may be introduced into the scaffold to enhance mycelium strength (desired characteristic) (see ¶ [0010], [0092], [0105]). McIntyre further discloses wherein said secondary biocompatible material is one of agarose and gelatin to provide a secondary cross-linking agent (a secondary gelling agent, such as agar which comprises agarose (biocompatible material), may be introduced into the scaffold as a thickening agent (cross-linking agent) (see ¶ [0010], [0092], [0105]).
However, McIntyre does not teach: identifying a non-filamentous secondary cell-type desired for growth upon a mycelial scaffold, and one or more specific growth conditions favorable for growth of the non-filamentous secondary cell-type (claim 21’s 1st step); or introducing the non-filamentous secondary cell-type into the inoculated medium for incubation and co-cultivation of the filamentous organism and the non-filamentous secondary cell-type into the mycelial scaffold (claim 26).
Minty discloses a step of introducing a non-filamentous organism into a culture medium for incubation (citric acid producing fungi, such as A. niger, are cultured in a bioreactor, following which the bioreactor containing culture medium is directly inoculated with PGA-producing Bacillus sp. (non-filamentous organism) and incubated (see page 19, lines 9-12; page 21, lines 31-33; page 22, lines 1-2) and co-cultivation of a filamentous organism and said non-filamentous organism into a scaffold (citric acid producing fungi, such as A. niger, are cultured in a bioreactor, following which the bioreactor containing culture medium is directly inoculated with PGA-producing Bacillus sp. (non-filamentous organism) and incubated (co-cultivation) on solid media (scaffold) (see page 19, lines 9-12; page 20, lines 26-28; page 21, lines 31-33; page 22, lines 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McIntyre’s method for the integration of a step of identifying and introducing a non-filamentous organism into a culture medium for incubation and co-cultivation of a filamentous organism and said non-filamentous organism into a scaffold such as taught by Minty to include a method of generating a mycelial scaffold by inoculating and culturing filamentous fungi in a suitable culture medium, which results in the formation of a mycological polymer, Minty discloses a step of introducing a non-filamentous organism into a culture medium for incubation and co-cultivation of a filamentous organism and said non-filamentous organism into a scaffold, and this combination would provide a method of generating a mycelial scaffold and co-cultivating non-filamentous organism cells on the mycelial scaffold, wherein the mycelial scaffold or the products obtained therefrom, may be beneficial for the growth of the non-filamentous organism, thereby offering an efficient and bio-compatible method for cultivation of useful non-filamentous cultures in vitro.
Claims 27, 29-30, and 35-39 are rejected under 35 U.S.C. 103 as being unpatentable over McIntyre in view of Minty as applied to claims 21-26, 34, and 41 above, and in further view of Marga (US 2015/0079238 A1) and Kozubal (WO 2017/151684 A - citation #371 of page 14 in the IDS filed on 10/20/2023).
The combined disclosures of McIntyre and Minty is discussed above.
However, modified-McIntyre-Minty does not teach: wherein the non-filamentous secondary cell-type is one of bovine, fish, plant, or a myocyte (claims 27, 30, and 36-39); or wherein the filamentous organism is of the genus Rhizopus (claim 29); or wherein the defined environment comprises a carbon dioxide content of from 3-7% (claim 35).
Marga’s general disclosure relates to edible microcarriers for culture and growth of cells and formation of engineered meats (see abstract & ¶ [0004]). Marga teaches the culturing of several cell types with relevance to meat, for example, bovine and fish (see ¶ [0077]). Any appropriate cell type may be used, for example, the cells may be non-human myocyte cell (see ¶ [0055]) and plant (see ¶ [0043]).
Kozubal’s general disclosure relates to a method of growing fungi which uses an artificial media and produces high density filamentous fungi biomats which produce a large variety of useful products (see abstract ¶ [1]-[10]). Kozubal teaches isolated filamentous fungal strains that includes Rhizopus species (see ¶ [1], [12]-[14]).
It would have been first obvious to use or substitute the filamentous fungal strain of Rhizopus such as taught by Kozubal in the method of modified-McIntyre-Minty. The MPEP 2143(I) provides examples of rationales that may support a conclusion of obviousness include: (b) simple substitution of one known element for another to obtain predictable results. Thus, the use of a fungal strain from Rhizopus in McIntyre’s methodology is deemed to be a simple substitution because both references are drawn to filamentous fungal strains. Furthermore, it would also have been obvious to use or substitute the non-filamentous secondary organism of a bovine, fish, plant, or a myocyte such as taught by Marga in the method of modified-McIntyre-Minty for co-cultivation which allows for the culture or growth of secondary cell types.
Regarding the carbon dioxide content, Kozubal teaches that “while the microbial mat is active, cells are respiring; that is, producing carbon dioxide and heat, as well as consuming oxygen. Accumulating carbon dioxide can reduce availability of oxygen and should be limited” (see ¶ [148]). Thus, this is motivation for someone of ordinary skill in the art to practice or test the parameter values widely to find those that are functional or optimal which then would be inclusive or cover those values as instantly claimed. Absent any teaching of criticality by the Applicant concerning the carbon dioxide content, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variable which can be met as a matter of routine optimization (MPEP 2144.05 II).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over McIntyre in view of Minty as applied to claims 21-26, 34, and 41 above, and in further view of Pelling (WO 2017/136950 A - citation #370 of page 14 in the IDS filed on 10/20/2023).
The combined disclosures of McIntyre and Minty is discussed above.
However, modified-McIntyre-Minty does not teach: decellularizing the mycological biopolymer to form a decellularized filamentous scaffold (claim 32).
Pelling discloses decellularizing a mycological biopolymer growth to form a decellularized filamentous scaffold (chitin-based 3D scaffold biomaterial (biopolymer growth) comprising a decellularized fungal tissue (mycological), wherein the fungus is white mushroom (filamentous); abstract; page 13, lines 1-2), thereafter adding a liquid medium for cultivation of a selected cell line of a non-filamentous organism (seeding the scaffold with animal cell lines (non-filamentous organism) in liquid medium, and incubating for adherence (cultivation); abstract; page 51, lines 12-29); inoculating a non-filamentous organism into said liquid medium (a liquid medium is inoculated with animal cell lines; page 51, lines 12-16), and incubating said inoculated liquid medium for a time sufficient for the growth of said non-filamentous organism into said decellularized filamentous scaffold to from a composite cellular mass (seeding the decellularized scaffold with animal cell lines (non-filamentous organism) in liquid medium, and incubating, adherence to scaffold (growth of non-filamentous organism into decellularized filamentous scaffold), and proliferating the cells (cultivation) to form an implant for tissue regeneration and cosmetic surgery (composite cellular mass); abstract; page 51, lines 12-29; page 52, lines 3-5).
It would have been obvious to a person of ordinary skill in the art to have modified McIntyre-Minty’s method for the integration of decellularizing a mycological biopolymer growth to form a decellularized filamentous scaffold, thereafter adding a liquid medium for cultivation of a selected cell line of a non-filamentous organism; inoculating a non-filamentous organism into said liquid medium, and incubating said inoculated liquid medium for a time sufficient for the growth of said non-filamentous organism into said decellularized filamentous scaffold to from a composite cellular mass such as taught by Pelling to include a method of generating a mycelial scaffold by inoculating and culturing filamentous fungi in a suitable culture medium, which results in the formation of a mycological polymer, the Pelling reference discloses decellularizing a mycological biopolymer growth to form a decellularized filamentous scaffold, thereafter adding a liquid medium for cultivation of a selected cell line of a non-filamentous organism; inoculating a non-filamentous organism into said liquid medium, and incubating said inoculated liquid medium for a time sufficient for the growth of said non-filamentous organism into said decellularized filamentous scaffold to from a composite cellular mass, and this combination would provide a method of generating a decellularized mycelial scaffold and cultivating non-filamentous organism cells on the mycelial scaffold, wherein the decellularization of the fungal scaffold eliminates the possibility of interference or contamination of the animal cells being cultured, and the fungal scaffold is bio-compatible and fit to be implanted into a recipient subject in need thereof, thereby offering an efficient, bio-compatible, and low-cost method for cultivation of useful non-filamentous animal cell cultures in vitro, and implantation of the same.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21, 26-33, 36, and 38-40 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over at least claims 1-6, 8-9, and 19 (claim set as filed on 03/24/2025) of co-pending parent Application no. 17/293,413. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Co-pending ‘413 teaches a method of generating a mycelial scaffold comprising the steps of inoculating a filamentous organism and a non-filamentous organism into a medium containing nutrition for cultivation and growth of said filamentous organism and said non-filamentous organism, and incubating said inoculated medium in a defined environment for a time sufficient for the growth of a mycological biopolymer, as a one piece self-contained scaffold, further characterized in that the non-filamentous organism is selected from the group consisting of: a cell of a chordate organism, a mammal cell, a fish cell, a bird cell, a reptile cell, an amphibian cell, a plant cell, a non-chordate cell, a mollusk cell, a myocyte, a neuron, a neuroglial cell, a lung cell, a fibroblast, a chondrocyte, an endothelial cell, an osteocyte, an osteoblast, an adipocyte, a stem cell, a yeast, a filamentous fungus, a cell of a coral, a cell of a shell structure, a chordate myocyte of a bovine, avian or fish cell line (see co-pending ‘413’s claims 1-5 and 8-9 which reads on the instant claims 21, 26-31, 36, and 38-40).
Co-pending ‘413 further teaches decellularization (co-pending ‘413’s claim 6 which reads on the instant claim 32).
Co-pending ‘413 further teaches the steps of growing the mycological biopolymer within a scaffold tray unit; delivering air to said tray unit for growth of the mycological biopolymer therein; thereafter decellularizing said mycological biopolymer to form a decellularized filamentous scaffold within said scaffold tray unit; introducing a flow of fetal bovine serum containing growth factors into said filamentous scaffold; thereafter delivering a flow of beef myocytes into said decellularized filamentous scaffold for attachment to and in said filamentous scaffold to form a composite mass of hyphae and myocytes; and processing said mass as an alternative meat product (co-pending ‘413’s claim 19 which reads on the instant claim 33).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims were allowed.
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653