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
Status of the application
Claims 1, 3-10, 12-15, 17-22, 24 are pending in this office action.
Claims 1, 3-10, 12-15, 17-22, 24 have been rejected.
Claim Rejections - 35 USC § 103
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.
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 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.
Claim(s) 1, 3, 12-15,17 is rejected under 35 U.S.C. 103 as being unpatentable over R1 et al. (Applicants filed as CHEManager as filed on 4/22/2025, entitled “Coupling Trends in cultured meat and Entomophagy 6 pages, 2019) (Hereinafter R1) in view of NPL Chan et al. (Chapter 8 and Year 2016 Please see page 4, bottom bold lines). and further.
Regarding claims 1, 3, 15, 17, R1 et al. discloses an in vitro method of making edible fat tissue (e.g. “in vitro large-scale cell culture for food production using insect fat cells; page 3, paragraphs 3,4). R1 et al. discloses the method comprising seeding a population of insect cells culture which could provide a preferable platform for large scale cell culture for food production (page 3, e.g. “insect fat cells are coupled with three-dimensional biomaterials”; page 3, paragraphs 3-4) and coupling cells with a scaffold system for differentiation and tissue maturation ( SEE at least page 3, paragraphs 3,4 which is under “Cultured Meat”) which reads on claim limitation of “onto a scaffold, wherein the scaffold is two- or three dimensional” of claim 1 (SEE at least page 3, paragraph 1 under “Cultured Meat”). R1et al. also discloses contacting the population of insect cells with a cell media (SEE at least page 3, paragraph 1 under “Cultured Meat”), thereby producing an edible fat tissue (expanding insect fat cells in vitro by differentiating with the help of natural insect hormone in serum free growth media, thereby producing an edible fat tissue; page 3, paragraphs 3-4). R1 et al. further discloses wherein the population of insect cells is a population of precursor cells (the population of the insect cells is isolated adipose precursor cells from a donor animal e.g. insect; page 3, paragraphs 2-3 “e.g. under cultured meat, last para, last line e.g. “expanded under in vitro condition”).
R1 et al. thereby accumulating lipids in the population of insect cells and producing therefrom an edible fat tissue.
R1 et al. is specifically silent about the population of insect cells growing in a cell culture media (i) containing a free fatty acid composition or a lipid composition as claimed in claim 1 and (ii) thereby accumulating lipids in the population of insect cells and producing therefrom an edible fat tissue as claimed in claim 1 and (iii) “wherein the population of insect cells have been enriched in lipid content by exposure to a free fatty acid composition or a lipid composition” as claimed in claim 15.
With respect to (i) NPL Chan et al. discloses that lepidopteran insect cells can grow in cell culture media with many formulations which include cholesterol, organic acids, oil etc. (Chapter 8, at least page 170) and lipid can be in an emulsion form (chapter 8, at least page 184, last two lines item #12). Therefore, NPL Chan et al. also meets claim limitations of “lepidopteran insect cells” of claims 3, 17.
One of ordinary skills in the art before the effective filling date of the claimed invention would have been motivated to modify the method of R1 et al. with the teaching of NPL Chan et al. to incorporate media formulation which includes cholesterol, organic acids, oil etc. (Chapter 8, at least page 170) suitable for the growth of lepidopteran insect cells (Chapter 8, at least page 170) and lipids as nutritional supplement can be in an emulsion form (chapter 8, at least page 184, last two lines item #12).
It is to be noted that R1 et al. discloses “scaffold system” ((page 3 under Cultured Meat e.g. “scaffold System”).
NPL Chan et al. discloses that Serum free medium to grow Lepidopteran insect cells can have many formulations which include cholesterol, organic acids, oil etc. (Chapter 8, at least page 170) and lipid can be in an emulsion form (chapter 8, at least page 184, last two lines item #12).
With respect to (ii) and (iii), NPL KIM discloses insects are Lepidoptera (Lepidoptera (caterpillars) have an average fat content of 27.66%; page 524, last paragraph). Therefore, lepidopteran insect cells are enriched in lipid content and would have been suitable to accumulate fat. With respect to (iii), regarding claim 15, the rejection made for the common claim limitations used for the composition made using in vitro method of claim 1 is applicable for claim 15 here. In addition, it is to be noted that and as mentioned for claim 1 above. R1 discloses the method comprising seeding a population of insect cells culture which could provide a preferable platform for large scale cell culture for food production (page 3, e.g. “insect fat cells are coupled with three-dimensional biomaterials”; page 3, paragraphs 3-4). It would have been obvious that one of ordinary skill in the art can consider container to provide the platform for the growth of insect cells having an enriched lipid content for its use in food application.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify the method of R1 et al. in view of NPL Chan et al. to include the teachings of NPL Kim et al. to consider growing the population of insect cells of high lipid containing Lepidoptera insect cells (in NPL Kim page 524,last paragraph), because Lepidoptera are edible insect with high fat nutrients and precursor cell population isolated at least from Lepidoptera insect cell population as precursor cells, will be suitable to make and accumulate edible fat tissue with a desired amount and type of free fatty acid or lipid component by growing in a media enriched with free fatty acid or lipid component in growth media to generate accumulation of fat in cultured tissue having desired high nutritional value.
Regarding claim 12, R1 et al., discloses the method of claim 1. In addition, R1 further discloses comprising the step of isolating a population of insect cells (e.g. isolating skeletal muscle and adipose precursor cells from a donor animal e.g. page 3, paragraphs 3, 4 which are Two paragraphs Under “Cultured Meat”).
Regarding claim 13, R1 et al. discloses the method of claim 1. In addition, R1 et al. further discloses a composition of matter made from the method of claim 1. (page 3, paragraphs 3, 4 which are Two paragraphs Under “Cultured Meat”).
Regarding claim 14, R1 et al. discloses the composition of matter of claim 13. R1 further discloses a food product containing the composition of matter (food product comprising insect fat cell edible and healthful tissue; page 3, paragraph 3). As per claim 15, R1 et al. discloses an in vitro edible fat tissue (food product comprising insect fat cell edible and healthful tissue; page 3, paragraphs 3, 4 page 3, paragraphs 3, 4 which are Two paragraphs Under “Cultured Meat”).
However, claims 13 and 14 are product -by- process claims.
The Examiner notes that claims 13 and 14 are product-by-process claims.
Therefore, it is to be noted that, in this case, the courts have held that when the prior art factor appears to differ from the claimed factor only in the method of obtaining the factor, the burden of persuasion was on applicants to show that the claimed product exhibited unexpected properties compared with that of the prior art. The courts further noted that “no objective evidence has been provided establishing that no method was known to those skilled in this field whereby the claimed material might have been synthesized.” 10 USPQ2d in 1926.
The courts also held that “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. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). See MPEP §2113.
Lastly the courts have held that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriads of processes put before it and then obtain prior art products and make physical comparisons therewith. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). The examiner further notes that “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP §2113.
Claims 4-5, 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over R1 et al. (Applicants filed NPL on 4/22/2025, 6 pages, 2019) in view of NPL Chan et al. and further in view of NPL Kim et al. (the publication entitled 'Edible Insects as a Protein Source: A Review of Public Perception, Processing Technology, and Research Trends' by Kim et al. (hereinafter NPL Kim et al.) as applied to claims 1 and 15 and further in view of Bayer et al. (US 2020/0157506 A1).
Regarding claims 4, 18, R1 et al., disclose the method of claim 1. R1 et al. does not disclose wherein the scaffold is a fungal scaffold.
Bayer et al. discloses scaffold is a fungal scaffold (a decellularized filamentous fungal scaffold; paragraph [0032]).
One of ordinary skill in the art before the effective filling date of the claimed invention, would have been motivated to modify the method of R1 et al. to include the teaching of Bayer et al. who discloses wherein the scaffold is a fungal scaffold as it provides unique plasticity, porosity and structure to be uniquely tunable for biomedical applications (Bayer et al., paragraph [0013]).
Regarding claims 5, 19, R1 et al. and Bayer et al. in combination, disclose the method of claim 4. R1 et al. does not disclose wherein the fungal scaffold is a decellularized Mycelium scaffold. Bayer et al. discloses fungal scaffold is a decellularized Mycelium scaffold (a decellularized filamentous mycelial scaffold; abstract; paragraphs [0013], [0032]).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify the method of R1 et al. to include the teaching of Bayer et al. who teaches wherein the fungal scaffold is a decellularized Mycelium scaffold as it is edible and provides unique plasticity, porosity and structure to be uniquely tunable for biomedical applications (Bayer et al., paragraph [0013]).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over R1 et al. (Applicants filed NPL on 4/22/2025, 6 pages, 2019) in view of NPL Chan et al. and further in view of NPL Kim et al. (the publication entitled 'Edible Insects as a Protein Source: A Review of Public Perception, Processing Technology, and Research Trends' by Kim et al. (hereinafter NPL Kim et al.) as applied to claim 1 and further in view of David et al. (WO 2020/131661 A1).
Regarding claim 6, R1 et al. discloses the method of claims 1-2.
R1 et al. does not disclose wherein the scaffold is two-dimensional, and the seeding is performed at a two-dimensional seeding density of at least one cell/cm^2, at least 15,000 cells/cm^2, at least 20,000 cells/cm^2, or at least 25,000 cells/cm^2 and at most 1,000,000 cells/cm^2, at most 500,000 cells/cm^2, at most 250,000 cells/cm^2, or at most 200,000 cells/cm^2, or at a range at or between the aforementioned values.
David et al. discloses that the scaffold is two-dimensional, and the seeding is performed at a two-dimensional seeding density of at least one cell/cm^2, at least 15,000 cells/cm^2, at least 20,000 cells/cm^2, or at least 25,000 cells/cm^2 and at most 1,000,000 cells/cm^2, at most 500,000 cells/cm^2, at most 250,000 cells/cm^2, or at most 200,000 cells/cm^2, or at a range at or between the aforementioned values ([0037] e.g. insect cells are seeded at a density of between 20,000 to 400,000 cells/cm^2 in the form of two dimensional film; and also paragraphs [0038], [0045], [0047]).
Regarding claim 7, in addition to the above discussion for claim 6, it is to be noted that David et al. also discloses that it can be three -dimensional seeding density also (at least in [0045]- [0047]) to meet claim 7.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify the method of R1 et al. to include the teaching of David et al. to include wherein the scaffold is two-dimensional, and the seeding is performed at a two-dimensional seeding density of at least one cell/cm^2, at least 15,000 cells/cm^2, at least 20,000 cells/cm^2, or at least 25,000 cells/cm^2 and at most 1,000,000 cells/cm^2, at most 500,000 cells/cm^2, at most 250,000 cells/cm^2, or at most 200,000 cells/cm^2, or at a range at or between the aforementioned values, as taught by R1 to achieve efficient cell expansion as claimed in claims 6,7.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over R1 et al. (Applicants filed NPL on 4/22/2025, 6 pages, 2019) in view of NPL Chan et al. and further in view of NPL Kim et al. (the publication entitled 'Edible Insects as a Protein Source: A Review of Public Perception, Processing Technology, and Research Trends' by Kim et al. (hereinafter NPL Kim et al.) as applied to claim 1 and further in view of Schmidt et al. (US 2012/0077181 A1).
Regarding claim 8, R1 et al. discloses the method of claims 1-2. R1 does not disclose further comprising the step of cryopreserving and thawing the population of insect cells seeded on the scaffold. Schmidt et al. discloses method comprising the step of cryopreserving and thawing the population of cells seeded on the scaffold (methods for cryopreserving cells and thawing cells and tissue assemblies adhered to a mechanically stable and biocompatible three-dimensional support; abstract; paragraph [0030]). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of R1 to include further comprising the step of: cryopreserving and thawing the population of insect cells seeded on the scaffold, as taught by Schmidt et al. for short- and long-term preservation of cells under closely monitored, reproducible and cost-effective conditions.
Claims 9, 10, 20, 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over R1 et al. (Applicants filed NPL on 4/22/2025, 6 pages, 2019) in view of NPL Chan et al. and further in view of NPL Kim et al. (the publication entitled 'Edible Insects as a Protein Source: A Review of Public Perception, Processing Technology, and Research Trends' by Kim et al. (hereinafter NPL Kim et al.) as applied to claims 1, 15 and further in view of Inlow et al. USPN 5372943 A.
Regarding claims 9, 10, 20, 21, 24, NPL Chan et al. discloses that lepidopteran insect cells can grow in cell culture media with many formulations which include cholesterol, organic acids, oil etc. (Chapter 8, at least page 170) and lipid can be in an emulsion form (chapter 8, at least page 184, last two lines item #12).
Even if NPL Chan et al. disclose “lipid emulsion”, however, claims 9, 10, 20, 21, 24 claims “emulsion form”. Therefore, they are rejected here to provide motivation for “emulsion” form using another secondary prior art by of Inlow et al.
R1 et al.in view of NPL Chan, NPL Kim et al. are silent about (i) the concentration of lipid in the cell media composition as claimed in claim 9 and (ii) lipid composition is an emulsion as claimed in claims 9, 10, 20,21 and it is seed oil as claimed in claim 10 and it is a soybean oil emulsion as claimed in claim 24.
Inlow et al. discloses methods to provide lipids in the form of microemulsion by dispersing lipids in culture media which is suitable in a bioavailable form to provide essential lipids to support growth of insect cells (At least in Abstract, col 5 lines 62 and Table 1). Inlow et al. also discloses that an advantage of lipids being supplied in the form of a microemulsion, in addition to enhancing the availability of the lipids to the insect cells, is in providing the option of not having to filter sterilize the lipid fraction and the rest of the media components separately. The lipid microemulsions of this invention can be added to the media without being filtered sterilized, and the entire media can then be filter sterilized without the concern of lipid loss during the filter sterilization process. For large-scale production, such an advantage is significant. However, it is of course possible to filter sterilize the lipid solution component and aqueous component separately and prepare the lipid microemulsion aseptically (at least in Table 1 and col 5 lines 60-67, col 6 lines 1-5).
Regarding claim 9, regarding the conc. of lipid, e.g. the disclosed cod liver oil (Table 1), it is known that an average MW of typical fish oil triglyceride is about 900 g/mol (Google).
(i)If we consider 10 mg/L cod liver oil (Table 1), it is 0.01 g/L.
(ii) Dividing by 900 g/mol gives a molarity about 1.11x 10 -5 M.
(iii) In mM, it is approximately 0.011 mM
This is based on the known calculation Molarity = mass conc. (10mg/L) /Av MW (900).
For cholesterol, 4.5 mg/L (Table 1), it will be 0.0116 mM (MW of cholesterol is 386.654 g/mol).
If we consider the upper range value of cod liver oil (50 mg/L), cholesterol (7 mg/L) and other lipids in the composition, then, based on the calculation above, total amount will overlap the claimed 0.1 mM to 10 mM as claimed in claim 9. It shows prima facie case of obviousness according to MPEP 2144.05.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify R1 et al. to consider the teaching of Inlow et al. who discloses methods to provide lipid in the form of microemulsion by dispersing lipids in culture media which is suitable in a bioavailable form to provide essential lipids to support growth of insect cells (At least in Abstract, col 5 lines 62 and Table 1). Inlow et al. also discloses that an advantage of lipids being supplied in the form of a microemulsion, in addition to enhancing the availability of the lipids to the insect cells, is in providing the option of not having to filter sterilize the lipid fraction and the rest of the media components separately.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over R1 et al. (Applicants filed as CHEManager as filed on 4/22/2025, entitled “Coupling Trends in cultured meat and Entomophagy 6 pages, 2019) (Hereinafter R1) in view of NPL Chan et al. (Chapter 8 and Year 2016 Please see page 4, bottom bold lines). and further in view of NPL Kim et al. (the publication entitled 'Edible Insects as a Protein Source: A Review of Public Perception, Processing Technology, and Research Trends' by Kim et al. (hereinafter NPL Kim et al.). and further in view of Bayer et al. (US 2020/0157506 A1).
Regarding claim 22, it is to be noted that the rejection made for the common claim limitations used for the composition made using R1 et al. in view of NPL Chan et al. and NPL Kim et al. is applicable for claim 22 here. In addition, it is to be noted that and as mentioned for claim 1 above. R1 discloses the method comprising seeding a population of insect cells culture which could provide a preferable platform for large scale cell culture for food production (page 3, e.g. “insect fat cells are coupled with three-dimensional biomaterials”; page 3, paragraphs 3-4). Therefore, it would have been obvious that one of ordinary skill in the art can consider container to provide the platform for the growth of insect cells having an enriched lipid content for its use in food application.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify the method of R1 et al. in view of NPL Chan et al. to include the teachings of NPL Kim et al. to consider growing the population of insect cells of high lipid containing Lepidoptera insect cells (in NPL Kim page 524,last paragraph), because Lepidoptera are edible insect with high fat nutrients and precursor cell population isolated at least from Lepidoptera insect cell population as precursor cells, will be suitable to make and accumulate edible fat tissue with a desired amount and type of free fatty acid or lipid component by growing in a media enriched with free fatty acid or lipid component in growth media to generate accumulation of fat in cultured tissue having desired high nutritional value.
However, (additionally), the examiner used Bayer et al. to address claim 22.
R1 et al. in view of Chan et al. and NPL Kim et al. are specifically silent about the claim limitation of “seeding a population of insect cell into a container” as claimed in claim 22.
Bayer et al. discloses an in vitro method to produce biocompatible and biodegradable mycelium scaffolds with unique plasticity of manufacture, allowing for porosity and structure to be uniquely tunable for biomedical applications ([0013]). Bayer et al. also discloses that after development of the three-dimensional filamentous network has concluded, the culture media within the vessel is replaced with chemistry designed to decellularize the hyphal matrix, retaining the structural wall matrix of the fungal cells while removing all components with the potential to interfere in non-filamentous cell growth, creating a decellularized filamentous scaffold.
One of ordinary skills in the art before the effective filling date of the claimed invention, would have been motivated to modify the method of R1 et al. in view of Chan and NPL Kim et al. to include the teaching of Bayer et al. who discloses wherein the scaffold is a fungal scaffold as it provides unique plasticity, porosity and structure to be uniquely tunable for biomedical applications (Bayer et al., paragraph [0013]).
Conclusion
NPL Li et al. (in Frontiers in Bioengineering and Biotechnology vol 10, pages 1-12, 2022 as submitted by applicants on 4/22/2025) is a related prior art.
NPL LI discloses contacting the population of animal cells with a specific adipogenic media (page 5 col 2 paragraph 2 e.g. “Preparation of adipose -like media) , thereby accumulating lipids in the population of animal cells and producing therefrom an edible fat tissue (preparation of the adipose-like Layer (i.e. fat layer) by culturing 3T3-L1 pre-adipocytes cell in adipogenic medium supplemented with 10% FBS, thereby accumulating lipid in 3T3-L1 pre-adipocytes on the GS scaffold and producing of fat containing meat; abstract; page 3 , Fig. and page 5, column 2, paragraph 2; page 8, column 2, paragraph 2).
However, NPL Li discloses different cell lines 3 T3 -L1. Fat cell accumulation using insect cell in a scaffold system is disclosed by R1 et al. (at least, page 3 Under “Cultured Meat”).
24. 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
