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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/6/25 has been entered.
Claim Status
Applicant’s arguments and amendments dated 11/6/25 have been received and entered in the application.
Claims 1-3, 5, 7-8, 10-11, 14, 20, 31-50 are currently pending and examined on the merits.
Claims 1, 11, 35-36, 40, 48-49 are currently amended.
Information Disclosure Statement
Five IDS’ were received on 11/7/25. All references have been considered; however, due to the voluminous number of references in the IDS they have been only briefly considered. It is noted that the cloaking of a relevant reference by inclusion in a long list of citations may not comply with the Applicant’s duty of disclosure. Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948 (S.D. Fla. 1972). Therefore, the applicant is encouraged to present a concise statement as to the relevance of any particular documents known to be material for patentability as defined by 37 C.F.R. § 1.56.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/589,661, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The ‘661 disclosure is entirely silent as to a cultivation device which comprises any of a water purification unit, hydrolysis tank, a pump, a mixing tank, a storage tank, or a harvesting device. The earliest support for each of these limitations appears in Application No. 63/555,543. Therefore, claims 1-30 are afforded an earliest priority date of 2/20/24.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections rejections not specifically reiterated are hereby withdrawn.
Claim Rejections-35 USC §103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7, 9-10, 14, 31-33, 49-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mattick et al., (2015) Anticipatory life cycle analysis of in vitro biomass cultivation for cultured meat production in the United States. Environ. Sci. Technol., 49: pp. 11941-11949 (hereinafter Mattick) in view of R. Ian Freshney, “Preparation and Sterilization”, “Scale-up and Automation.” In: Culture of Animal Cell: A Manual of Basic Technique and Specialized Applications. (Hoboken, NJ, John Wiley & Sons, Inc., 2010), pp. 133-162, 497-515. QH585.2.F74 2010 (hereinafter Freshney)
Regarding claims 1-2, 10-11, 17-18, 31, 33, 49-50 Mattick discloses methods and systems for the large scale cultivation of cultured meat products (Abstract, Introduction). Mattick discloses that a system for large scale cultivation preferably contains a hydrolysis system, a transportation system, a cell proliferation system, and a cell differentiation system (Fig. 2).
Mattick discloses that hydrolysates of yeast, rice, soy and other plant or microbial material produced in the hydrolysis system may be added to media as supplementary sources of amino acids, peptides, vitamins, and trace elements (1.2, 2.1, Fig. 2). Each phase of production requires deionized water (2.4, Fig. 2).
The cell proliferation system preferably contains a source of deionized, sterilized water, aeration, agitation, pH regulation, and temperature regulation (Fig. 2). Preferably, the water is sterilized via microfiltration before the introduction of cells (2.4, Fig. 2). Mattick further discloses that the cell proliferation system takes place within a stirred-tank bioreactor to which cells, culture media, and other supplements may be added (1.2, Fig. 2). The bioreactor is also connected to a sparging system which delivers oxygen, carbon dioxide, or atmospheric air into the bioreactors (2.4, Fig. 2).
The cell differentiation system likewise contains a source of deionized, sterilized water, aeration, agitation, pH regulation, temperature regulation, and sparging, and takes place within a stirred-tank bioreactor (1.2, Fig. 2). An edible biomass may be obtained from either or both of the cell proliferation and cell differentiation systems (Fig. 2).
Regarding claim 5, Mattick discloses that it is known in the art to use 15,000 L capacity stirred-tank reactors for production of cellular biomass (2.3).
Regarding claim 7, Mattick discloses that system contains a sparging system which delivers oxygen, carbon dioxide, or atmospheric air into the bioreactors (2.4, Fig. 2).
Regarding claim 10, Mattick discloses that the cells must be maintained at a temperature of about 37° C, and that the system includes means for temperature regulation (2.4, Fig. 2).
Mattick does not disclose that the hydrolysis system is connected to a water purification system. However, Mattick discloses that each phase of production requires deionized water (2.4, Fig. 2). Therefore, there is a suggestion present in Mattick that the hydrolysis system could be coupled to a deionized water source.
Mattick does not disclose that the tanks are present in series via pumps and filtration units. Mattick also does not explicitly disclose that the system included a control unit.
Freshney discloses methods and systems for sterilization, scale-up, and automation of cell culture (Chp 10, 26). Freshney explains that all apparatus and liquids that come in contact with cultures must be sterilized (10.2). Sterile filtration is the method of choice for sterilizing heat-labile solutions (10.5.2). Sterile filtration is commonly performed using in-line filters with a peristaltic pump (110.2, 0.5.2, Figs. 10.12, 10.14).
Freshney explains that continuous and fed-batch culture systems may be set up with multiple vessels in series (26.1.1, Figs. 26.3). Vessels included in the systems may include media supply (e.g., mixing or storage tanks), multiple bioreactors, and collection devices (26.1, Figs. 26.3, 26.6-26.7). Flow rate between vessels may be regulated by a peristatlic pump between vessels (26.1.1, Fig. 26.3, 26.6-26.7). In some embodiments, the systems have sterile, in-line filters between vessels (Figs. 26.2, 26.11). Large-scale culture systems may additionally incorporate product receivers (i.e., harvesters) (26.4, Figs. 26.3, 26.6, 26.19). Freshney explains that implicit in systems for large-scale production are systems for automation (26.4). These typically involve a control unit which stores data and regulates conditions within the system, as well many other connected devices for physiochemical and physiological parameters (26.4, Figs. 26.19, 26.6-26.7).
Freshney does not explicitly disclose that the hydrolysis tank comprises a thermometer, conductometer, or shaft. However, Freshney explains that the control units typically incorporate many connected devices for monitoring and regulation of all parameters of the process, including temperature, and medium inputs (26.4, Figs. 26.19, 26.6-26.7). Therefore, there is a suggestion present in Freshney that the hydrolysis tank comprises monitoring devices.
As Mattick is directed to methods for the large-scale cultivation of cells, and Freshney is directed to systems for the large-scale culture of cells, it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would be motivated to use the well-known, routine and conventional systems disclosed by Freshney to the known methods of Mattick to yield the predictable result of large-scale culture.
Further, as per MPEP § 2144.04 rearrangement of parts where the rearrangement of the parts does not modify the ultimate function of the device is considered a routine expedient requiring no more than ordinary skill in the art. As the components of the claimed apparatus are all known elements which function for the cultivation of cells it would be obvious to one of ordinary skill in the art to utilize the particular series of components.
Regarding claim 32, the combination does not explicitly disclose that the maximum working volume of a culture vessel is a certain ration of the total volume of the vessel. However, this limitation is directed to an intended use of the apparatus rather than a structural feature thereof. Claim scope is not limited by language that does not limit an apparatus claim to a particular structure. That is, intended use of an apparatus is insufficient to distinguish the structure of the apparatus from the prior art. See MPEP §§ 2111.02 and 2111.04. Consequently, this limitation is not considered in analyzing the patentability of the apparatus or composition.
Claim(s) 11, 14, 34-36, 38-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mattick in view of Freshney as applied to claims 1-7, 9-10, 14, 31-33, 49-50 above and in further view of Andreassen et al., (2020) Screening of by-products from the food industry as growth promoting agents in serum-free media for skeletal muscle growth. Food Funct, 11: pp. 2477-2488 (hereinafter Andreassen) as evidenced by Deionized Water Conductivity. Datasheet [online]. Alpha Measurement Systems, 2024 [retrieved on 2025-08-05] Retrieved from the Internet:< https://alpha-measure.com/deionized-water-conductivity/>., (hereinafter Deionized Water Conductivity) and DMEM Formulation. Datasheet [online]. Sigma, 2025 [retrieved on 2025-08-05]. Retrieved from the Internet:< https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/cell-culture-and-cell-culture-analysis/mammalian-cell-culture/dulbecco-modified-eagle-medium-formulation?srsltid=AfmBOopRVx5X46PZSLoaKpxmoOZ1dCfVLQ7mGX68zBE_gwSRCfPMHmUQ (hereinafter DMEM).
Regarding claims 11, 14, 34, 39 Mattick discloses methods and systems for the large scale cultivation of cultured meat products (Abstract, Introduction). Mattick discloses that a system for large scale cultivation preferably contains a hydrolysis system, a transportation system, a cell proliferation system, and a cell differentiation system (Fig. 2).
Mattick discloses that hydrolysates of yeast, rice, soy and other plant or microbial material produced in the hydrolysis system may be added to media as supplementary sources of amino acids, peptides, vitamins, and trace elements (1.2, 2.1, Fig. 2). Each phase of production requires deionized water (2.4, Fig. 2).
The cell proliferation system preferably contains a source of deionized, sterilized water, aeration, agitation, pH regulation, and temperature regulation (Fig. 2). Preferably, the water is sterilized via microfiltration before the introduction of cells (2.4, Fig. 2). Mattick further discloses that the cell proliferation system takes place within a stirred-tank bioreactor to which cells, culture media, and other supplements may be added (1.2, Fig. 2). The bioreactor is also connected to a sparging system which delivers oxygen, carbon dioxide, or atmospheric air into the bioreactors (2.4, Fig. 2).
The cell differentiation system likewise contains a source of deionized, sterilized water, aeration, agitation, pH regulation, temperature regulation, and sparging, and takes place within a stirred-tank bioreactor (1.2, Fig. 2). An edible biomass may be obtained from either or both of the cell proliferation and cell differentiation systems (Fig. 2).
Regarding claim 14, Mattick discloses that that hydrolysates of yeast, rice, soy and other plant or microbial material produced in the hydrolysis system may be added to media as supplementary sources of amino acids, peptides, vitamins, and trace elements (1.2, 2.1, Fig. 2).
Mattick does not disclose that the hydrolysis system is connected to a water purification system. However, Mattick discloses that each phase of production requires deionized water (2.4, Fig. 2). Therefore, there is a suggestion present in Mattick that the hydrolysis system could be coupled to a deionized water source.
Regarding claim 35, Mattick does not disclose that the conductivity of the water is lower than 100 µS/cm. However, as evidenced by Deionized Water Conductivity, deionized water typically has a conductivity of less than 5.0 µS/cm. Therefore, it is inherent that the deionized water of Mattick would have a conductivity of less than µS/cm.
Regarding claims 11, Mattick does not explicitly disclose that the source material is combined with a protease to obtain the protein hydrolysate. However, Mattick discloses that raw materials, such as yeast, rice, soy and other plant or microbial materials, may be used to produce hydrolysates through hydrolysis (1.2, 2.1, Fig. 2). Therefore, it is implicit that the raw material is combined with a protease to produce the hydrolysate.
Mattick does not disclose that the tanks are present in series via pumps and filtration units.
Freshney discloses methods and systems for scale-up and automation of cell culture (Chp 26). Freshney explains that for continuous and fed-batch culture systems may be set up with multiple vessels in series (26.1.1, Figs. 26.3). Vessels included in the systems may include media supply (e.g., mixing or storage tanks), multiple bioreactors, and collection devices (26.1, Figs. 26.3, 26.6-26.7). Flow rate between vessels may be regulated by a peristatlic pump between vessels (26.1.1, Fig. 26.3, 26.6-26.7). In some embodiments, the systems have sterile, in-line filters between vessels (Figs. 26.2, 26.11). Large-scale culture systems may additionally incorporate product receivers (i.e., harvesters) (26.4, Figs. 26.3, 26.6, 26.19). Freshney explains that implicit in systems for large-scale production are systems for automation (26.4). These typically involve a control unit which stores data and regulates conditions within the system, as well many other connected devices for physiochemical and physiological parameters (26.4, Figs. 26.19, 26.6-26.7).
Regarding claim 38, Freshney discloses that in some embodiments in-line filters may have a 0.2 µm porosity (26.1, Fig. 26.2).
Freshney does not explicitly disclose that the hydrolysis tank comprises a thermometer, conductometer, or shaft. However, Freshney explains that the control units typically incorporate many connected devices for monitoring and regulation of all parameters of the process, including temperature, and medium inputs (26.4, Figs. 26.19, 26.6-26.7). Therefore, there is a suggestion present in Freshney that the hydrolysis tank comprises monitoring devices.
As Mattick is directed to methods for the large-scale cultivation of cells, and Freshney is directed to systems for the large-scale culture of cells, it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would be motivated to use the well-known, routine and conventional systems disclosed by Freshney to the known methods of Mattick to yield the predictable result of large-scale culture.
Further, as per MPEP § 2144.04 rearrangement of parts where the rearrangement of the parts does not modify the ultimate function of the device is considered a routine expedient requiring no more than ordinary skill in the art. As the components of the claimed apparatus are all known elements which function for the cultivation of cells it would be obvious to one of ordinary skill in the art to utilize the particular series of components.
The combination of Mattick and Freshney does not disclose that the total input of protein hydrolysate is between 8 to 50 g/L of dry protein weight.
Andreassen examines the use of food by-product hydrolysates in serum-free media for cell cultivation (Abstract, Introduction). Andreassen discloses generating protein lysates from each of pork plasma, chicken carcass, cod backbone, egg white powder, eggshell membrane, and yeast extract using various enzymes (Preparation of protein hydrolysates, Table 1). The hydrolysates are added to culture media at concentrations between 1 and 10 g/L (Supplementation with by-product hydrolysates and yeast extract to cell culture media enhanced cell growth when serum was present and restored cell growth when serum was reduced and depleted). Andreassen discloses that some of the hydrolysates are able to restore cell metabolism and proliferation in reduced and serum-free conditions in a dose-dependent manner (Supplementation with by-product hydrolysates and yeast extract to cell culture media enhanced cell growth when serum was present and restored cell growth when serum was reduced and depleted, Fig. 7-8). Andreassen further hypothesizes additional effects may be achieved by mixing different hydrolysates (Supplementation with by-product hydrolysates and yeast extract to cell culture media enhanced cell growth when serum was present and restored cell growth when serum was reduced and depleted). Therefore, Andreassen teaches that the concentration of protein hydrolysate to be added is a results effective variable which may be optimized depending on the protein source and enzyme utilized. See MPEP § 2144.05.
Regarding claim 36, Andreassen discloses that the protein hydrolysate is added to DMEM for the culture (Cell culture and treatment). As evidenced by DMEM, DMEM contains 1.038 g/L of amino acids.
Regarding claim 40, Andreassen discloses that the degree of hydrolysis is dependent on the enzyme utilized, and that in some embodiments 80% of the hydrolysates are composed of short peptides of less than 15 peptides (Choice of by-product material and enzyme affected protein degradation during hydrolysis).
As Mattick and Andreassen are both directed to methods of cultivating cells utilizing protein hydrolysates, it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would understand that the concentrations disclosed in Andreassen could be utilized in the methods of the combination as a combination of known elements according to known methods to yield a predictable result of culturing cells with a protein hydrolysate.
Response to Arguments
Applicant’s arguments and amendments dated 11/6/25 have been fully considered but are moot in part and not persuasive in part due to the new grounds of rejection necessitated by applicant’s amendments. To the extent that the arguments are pertinent to the current grounds of rejection they are responded to below.
Claim(s) 1-7, 9-10, 14, 31-33, 49-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mattick in view of Freshney.
Applicant argues that Mattick does not disclose the defined sequence, dedicated pumps, and sterile filtration units in the system, in particular the use of two distinct filtration steps (Response p12-13). Applicant argues that the apparatus as claimed is strategically structured to support continuous flow, maintain sterility, and handle high nutrient concentrations from hydrolysate-based media (Response p14-15).
In response Freshney is utilized to demonstrate that is known in the art to utilize multiple vessels in series via pumps and filtration systems for large-scale cultivation of cells. Freshney explicitly states that in-line, sterile filtration is a well-known and conventional means for the sterilization of culture components. Further, as per MPEP § 2144.04 rearrangement of parts where the rearrangement of the parts does not modify the ultimate function of the device is considered a routine expedient requiring no more than ordinary skill in the art. As the components of the claimed apparatus are all known elements which function for the sterile, cultivation of cells, it would be obvious to one of ordinary skill in the art to utilize the particular series of components, including multiple filtration steps.
Claim(s) 11, 14, 34-36, 38-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mattick in view of Freshney and Andreassen, and as evidenced by Deionized Water Conductivity and DMEM.
Applicant argues that Andreassen teaches away from concentrations of 10 mg/mL of protein dry weight (Response p13-14).
In response, Andreassen discloses that cytotoxicity at the upper limit is dependent on the combination of enzyme and raw material utilized; the combination of pork plasma and Alcalase does not demonstrates cytotoxicity at the upper limit (Fig. 5). Andreassen further suggest that additional effects may be achieved by mixing different hydrolysates (Supplementation with by-product hydrolysates and yeast extract to cell culture media enhanced cell growth when serum was present and restored cell growth when serum was reduced and depleted). Therefore, Andreassen teaches that the concentration of protein hydrolysate to be added is a results effective variable which may be optimized depending on the protein source and enzyme utilized. See MPEP § 2144.05.
Allowable Subject Matter
Claims 20, 41-48 are allowed.
Claim 37 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 20, 41-48 are allowed. Claim 37 is objected to. Claims 1-3, 5, 7-8, 10-11, 14, 31-36, 38-40, 49-50 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632