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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/05/2026 has been entered.
Claims 1-8, 10-12 have been amended. No claims have been newly added or newly canceled.
Claims 1-20 are currently pending and have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendments. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Interpretation
Applicant has replaced the term “washing” and “rinsing” with the term “flushing”. Applicant has defined the term “washing media” to refer to “a liquid for washing cells after cells have grown into a grown cell mass, in particular, a washing media may be utilized to flush cell culture media from a grown cell mass. For example, a washing media can include Phosphate Buffered Saline (PBS), citric acid/potassium dibasic buffers, or other solutions to rinse or wash a grown cell mass” (Specification pages 9-10 para 31).
However, Applicant has not specifically defined the terms “washing”, “flushing” or “rinsing” to distinguish these terms from each other and therefore these terms are interpreted broadly to be equivalent to each other. This is consistent with Applicant’s specification which indicates that a washing media can be used to wash, flush or rinse a grown cell mass without any specified differences (pages 9-10 para 31).
Applicant has indicated that the use of the terms “first”, “second”, “third” are not necessarily used to connote a specific order or number of elements, but as generic identifiers (Specification page 47 para 149).
Claim Rejections - 35 USC § 112
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.
Claims 6, 10-12, and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The Court in Wands states: "Enablement is not precluded by the necessity for some 'experimentation." Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
Scope of the Invention
Claims 6 and 10 have been amended to require wherein the pH of the culture media that the cells are growing in is equal to the isoelectric point for meat proteins.
Guidance and Working Examples
Applicant’s disclosure indicates that the isoelectric point (pI) of meat proteins tends to be around 5-5.5 and that altering the pI based on the pH or vice versa to adjust behaviors of the grown cell mass can be included (see Specification page 34 para 108). However, the Specification does not provide any working examples or guidance for culturing/growing a cell mass in a culture medium that has a pH of 5-5.5, let alone wherein the pH of the culture media is equal to the isoelectric point for meat proteins in general.
State of the Art and Quantity of Experimentation
In the art of cultured meat, the pH of the culture media is indicated as critical for the viability and proliferation of the cells. Monitoring and maintaining the pH of the culture medium during the meat culture process is taught and suggested as essential for providing the proper environment for the viability and health of the cells.
O’Neill (Comprehensive Reviews in Food Science and Food Safety 2021) disclose that the pH and ion balances in culture media for cultivated meat production need to emulate physiological conditions (typically around pH 7.4) for optimal cell growth (page 689, section 4.3).
Djisalov (Biology 2021) disclose that the pH of the cell culture medium in cultured meat production can provide information about cell growth rate and metabolism since the lower pH indicates a buildup of the acidic waste products and the optimal pH for animal cell culture is 7.4. Even a small change of 0.1 pH units from the optimum can have an extreme impact on cell viability and growth rate. In bioreactors, pH is typically monitored using electrochemical and optical sensors (page 15 of 42).
Soleymani (Journal of Agriculture and Food Research, 2024) disclose that the cell culture medium is a crucial component in the cultivation of muscle and muscle cells for the manufacture of cultured meat. This specialized nutrient solution provides essential components to support the growing, proliferation, and diversity of muscle cells in vitro. The development of an optimal cell culture medium is essential for the successful manufacture of high-quality cultured meat products. Cell culture medium is a complex and carefully formulated solution designed to mimic the natural environment of cells, providing the necessary nutrients, growth factors, and other essential components to support cell growth and function. In the context of cultured meat production, the cell culture medium is specifically tailored to provision the growing and variation of muscle cells, allowing the generation of muscle tissue that closely resembles natural meat (page 7 section 3.2.1). Soleymani disclose that pH buffering agents are essential for maintaining the optimal pH of the cell culture medium which is critical for cell viability and function (page 7 section 3.2.1).
There is nothing in the art of cell culture in general or in the art of cultured meat in particular that indicates that the culture medium is ever to be permitted to fall below the optimal pH of the cells being cultured (approximately 7 pH) let alone to allow the pH of culture medium to be equal to an isoelectric point of meat protein at a pH of 5. The quantity of experimentation that would be required for one skilled in the art to make and use the instantly claimed invention is deemed to be undue given the lack of guidance.
Conclusion
In conclusion, given the breadth of the claims, the lack of guidance in both Applicant’s Specification and in the art of cultured meat, an undue quantity of experimentation would be required to make and use the claimed invention.
Claims 1-20 are 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. (New Matter Rejection)
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.
Applicants have entered the limitations regarding where a 2nd or 3rd pH are different and higher from a previous pH in claims 1, 3, 4, 5, 7, and 8. Applicants have also entered the limitations regarding where the pH of the culture medium equals an isoelectric point for meat proteins in claims 6 and 10. There is insufficient support in the disclosure as originally filed for these limitations; thus, they are being considered new matter.
An amendment to the claims or the addition of a new claim must be supported by the description of the invention in the application as filed. In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989). Applicant is required to cancel the new matter in the reply to this Office Action.
Applicant is hereby notified that the insertion of new matter into the claims has necessitated the removal of the art rejection over claims 6, 10-12, and 17. However, removal of new matter will result in the reinstatement of the art rejection.
The introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112, first paragraph. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir.1996).
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 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, 3, 4, 5, 7, 8-9, 13-16, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lavon et al (WO 2020/222239-from IDS filed 05/18/2023).
Regarding claim 1, Lavon discloses a method for washing and enriching cultured meat products (comestible food product) (page 4,Iines 7-8, page 34, In 3-6), comprising: growing a cell mass in cell culture media (page 4,In 9-13), removing at least a portion of the grown cell mass from the cell culture media (page 35, In 28-29); washing the grown cell mass with a washing media to flush out remaining cell culture media (page 15, In 23-24); and then rinsing (flushing) the grown cell mass with an enrichment media comprising nutrients (page 23, In 19-23). Lavon teaches and suggests that the cultured food is intended for human consumption (page 1 lines 9-24, page 26 lines 18-24) and therefore the nutrients included would be suitable for human consumption as well.
Lavon teaches and suggest wherein their water-based washing medium is saline and used to remove the growth medium (page 23 lines 19-24). Saline used for the processing of cultured meat is known to be isotonic and thus an obvious choice for the person of ordinary skill in the art of cultured meat. Flushing the grown cell culture with isotonic saline would dilute and remove the cell culture medium.
Lavon discloses wherein the pH of the medium is measured, monitored and adjusted to optimize cell viability (pages 6-7, 21, 23 and 35). Lavon discloses that the pH of the cell culture bioreactor is maintained withing a pH range of 6.7-7.2 +/- 0.1 (page 35 lines 23-26). This range allows for the pH of the bioreactor and any media used to vary over several possible pH values within that range and thus provide for at least a first, second and third media pH value that are different from each other.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to include two washing steps, one with isotonic saline to remove the culture medium and a second washing step to add nutrients, such as vitamins, to the cultured food product in their method because Lavon teach and suggest that both options are suitable and desirable for their method of preparing a cultured food product.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to utilize media with pH values of 6.7, 6.8, and/or 6.9 in the method of Lavon because Lavon teach and suggest that all three of these options are suitable and desirable for their method of preparing a cultured food product. This would have allowed for a second pH that was higher than the first pH and third pH that was different and higher than the second pH.
Regarding claims 3-4, Lavon discloses that the pH of the cell culture bioreactor is maintained withing a pH range of 6.7-7.2 +/- 0.1 (page 35 lines 23-26). This range allows for the pH of the bioreactor and any media used to vary over several possible pH values within that range and thus provide for at least a first, second and third media pH value that are different from each other.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to utilize media with pH values of 6.7, 6.8, and/or 6.9 in the method of Lavon because Lavon teach and suggest that all three of these options are suitable and desirable for their method of preparing a cultured food product. This would have allowed for a second pH that was higher than the first pH and third pH that was different and higher than the second pH.
Regarding claim 5, Lavon discloses that the pH of the cell culture bioreactor is maintained withing a pH range of 6.7-7.2 +/- 0.1 (page 35 lines 23-26). This range allows for the pH of the bioreactor and any media used to vary over several possible pH values within that range and thus provide for at least a first, second and third media pH value that are different from each other.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to utilize media with pH values of 6.7, 6.8, and/or 6.9 in the method of Lavon because Lavon teach and suggest that all three of these options are suitable and desirable for their method of preparing a cultured food product. This would have allowed for a second pH that was higher than the first pH and third pH that was different and lower than the second pH.
Regarding claim 7, Lavon discloses a method for enriching cultured meat products (comestible food product) (page 4, ln 7-8, page 34, ln 3-6), the method comprising: growing a cell mass in cell culture media (page 4 ln 9-13), removing the grown cell mass from the cell culture media (page 35, ln 28-29), and washing the grown cell mass (page 23, ln 19-23, page 21, ln 7-8).
Lavon does not expressly disclose washing the grown cell mass with a gradient washing media by decreasing concentrations of washing media and increasing concentrations of enrichment media over time.
However, it would have been obvious to one of ordinary skill in the art that gradient washing media/enrichment media could be incorporated which would allow for a gradual change in the cell environment and thus provide less stress on the biomass. One of ordinary skill in the art would have had a reasonable expectation of success as the sensors would indicate when a parameter in the medium has not reached a desired level (page 6 ln 8-11).
Lavon discloses that the pH of the cell culture bioreactor is maintained withing a pH range of 6.7-7.2 +/- 0.1 (page 35 lines 23-26). This range allows for the pH of the bioreactor and any media used to vary over several possible pH values within that range and thus provide for at least a first, second and third media pH value that are different from each other.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to utilize media with pH values of 6.7, 6.8, and/or 6.9 in the method of Lavon because Lavon teach and suggest that all three of these options are suitable and desirable for their method of preparing a cultured food product. This would have allowed for a second pH that was higher than the first pH and third pH that was different and higher than the second pH.
Regarding claim 8, Lavon discloses a method for enriching cell based comestible food products and washing (flushing) a cell mass (pg 4 ln 7-8, pg 34, ln 3-6) comprising: growing a cell mass in a cell culture media (pg 4 ln 9-13); flushing the cell mass with a first exchange water-based washing media to remove growth medium (pg 15 ln 23-24).
Lavon do not expressly disclose wherein the first exchange media comprises a lower concentration of membrane-permeable solute relative to the cell culture media.
However, Lavon do disclose wherein their water-based washing medium is saline and used to remove the growth medium (page 23 lines 19-24). Saline used for the processing of cultured meat is known to be isotonic and to have a lower concentration of membrane-permeable solute relative to a cell culture medium.
Lavon do not expressly disclose flushing the cell mass with a second exchange media comprising a higher concentration of membrane-permeable solutes relative to the first exchange media.
However, Lavon do disclose wherein their water-based washing medium is saline, used to remove the growth medium, and optionally to add additives to the cultured food product that increase its vitamin content and/or affect its appearance and/or taste (page 23 lines 19-24). A saline exchange medium fortified with vitamins will have a higher concentration of membrane-permeable solutes relative to the first exchange medium that only contains isotonic saline.
Also, it would have been obvious to one of ordinary skill in the art that the second exchange media could be incorporated if the sensors indicate that a parameter in the medium has not dropped to a desired level (page 6 ln 8-11). One of ordinary skill in the art would have had a reasonable expectation of success as the sensors would indicate when a parameter in the medium has not reached a desired level (page 6 ln 8-11).
Lavon discloses that the pH of the cell culture bioreactor is maintained withing a pH range of 6.7-7.2 +/- 0.1 (page 35 lines 23-26). This range allows for the pH of the bioreactor and any media used to vary over several possible pH values within that range and thus provide for at least a first, second and third media pH value that are different from each other.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to utilize media with pH values of 6.7, 6.8, and/or 6.9 in the method of Lavon because Lavon teach and suggest that all three of these options are suitable and desirable for their method of preparing a cultured food product. This would have allowed for a second pH that was higher than the first pH and third pH that was different and lower than the second pH.
Regarding claim 9, Lavon renders obvious the method of claim 12 as described above, and wherein flushing the cell mass with the first exchange media causes a first set of membrane-permeable solutes to diffuse out of the intracellular spaces of the cells in the cell mass (pg 23, ln 19-23); as a saline solution would cause membrane-permeable solutes to diffuse out of the intracellular spaces as defined by Applicant’s in the instant application (para 100).
Lavon does not expressly disclose flushing the cell mass with a second exchange media that causes a second set of membrane-permeable solutes to diffuse into the intracellular spaces of the cells.
However, it would have been obvious to one of ordinary skill in the art that the second exchange media with a slightly altered buffer composition would be incorporated when the sensors indicate that a parameter in the medium has not reached a desired level to ensure that all of the unwanted solutes are removed (pg 23, ln 19-23). Adding additives to the saline solution would cause membrane-permeable solutes to diffuse into or out of the intracellular spaces as defined by the instant application (para 100), para 40). One of ordinary skill in the art would have had a reasonable expectation of success as the sensors would indicate when a parameter in the medium has not reached a desired level (page 6 ln 8-11).
Regarding claim 13, Lavon discloses a first exchange media (page 23, ln 19-23).
Lavon does not expressly disclose wherein a second exchange media further comprises nutrients that adhere to external surfaces of cells within the cultured cell mass.
However, Applicant’s disclosure states that at least a portion of nutrients, such as vitamins, amino acids, antioxidants, proteins, carbohydrates or fats may adhere to an external surface of the cell when included in a second exchange medium (page 38 para 119). There is no disclosure of how this is accomplished, such as a specific required nutrient or a specific required dose, therefore this effect is deemed to be inherently present when the food product is washed with a nutrient enriched wash/rinse solution, baring evidence to the contrary.
Regarding claim 14, Lavon renders obvious the method of claims 8 as described above, and wherein the second exchange media is hypertonic relative to the first exchange media (pg 23, ln 19-23). Adding additives to the saline wash solution (such as vitamins as suggested by Lavon page 23 lines 19-23) would cause membrane-permeable solutes to diffuse into the intracellular spaces as defined by the instant application (para 100, para 40). One of ordinary skill in the art would have had a reasonable expectation of success as the sensors would indicate when a parameter in the medium has not reached a desired level (page 6 ln 8-11).
Regarding claim 15, Lavon renders obvious the methods of claims 8 and 12 as described above, and wherein the second exchange media comprises an increasing solute gradient and wherein the second exchange media transitions from a solution having a lower concentration of solutes to a solution having a higher concentration of solutes (page 23, ln 19-23). A saline solution would cause membrane-permeable solutes to diffuse out of the intracellular spaces as defined by Applicant’s in the instant application (para 39, para 100).
Regarding claim 16, Lavon renders obvious the methods of claims 8, 12 and 15 as described above, and wherein flowing the second exchange media comprising the increasing solute gradient across the cell mass provides a gradual change in solute concentrations, whereby osmotic stress on cells of the cell mass is reduced (pg 23, ln 19-23). Adding additives to a saline solution would cause membrane-permeable solutes to diffuse into the intracellular spaces as defined by Applicant’s in the instant application (para 40, para 100).
Regarding claim 18, Lavon renders obvious the method of claim 8 as described above, further comprising flushing the cell mass with the first exchange media.
Lavon does not expressly disclose flushing the cell mass with the first exchange media until a first effluent has a composition substantially similar to the first exchange media.
However, it would have been obvious to one of ordinary skill in the art that the flushing process would be repeated until all of the cell growth media had been removed from the biomass (pg 23, ln 19-23). One of ordinary skill in the art would have had a reasonable expectation of success because Lavon suggests that one skilled in the art could readily devise many variations and modifications of the principals disclosed therein (page 35, page 37).
Regarding claim 19, Lavon renders obvious the method of claim 8 as described above.
Lavon does not expressly disclose further comprising flushing the cell mass with a second exchange media until a second effluent has a composition substantially similar to the second exchange media.
However, it would have been obvious to one of ordinary skill in the art that the flushing process would be repeated until all of the first exchange media had been replaced with the second exchange media (pg 23, ln 19-23, pg 21, ln 7-8). One of ordinary skill in the art would have had a reasonable expectation of success because Lavon suggests that one skilled in the art could readily devise many variations and modifications of the principals disclosed therein (page 35, page 37).
Regarding claim 20, Lavon renders obvious the method of claim 8 as described above.
Lavon does not expressly disclose further comprising flushing the cell mass for a flushing time period.
However, it would have been obvious to one of ordinary skill in the art that the flushing process would be repeated for a period of time until all of the first exchange media had been replaced with the second exchange media (page 23, ln 19-23, page 21, ln 7-8). One of ordinary skill in the art would have had a reasonable expectation of success because Lavon suggests that one skilled in the art could readily devise many variations and modifications of the principals disclosed therein (page 35, page 37).
Therefore, the teaching of Lavon et al renders obvious Applicant’s invention as claimed.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lavon et al (WO 2020/222239-from IDS filed 05/18/2023) as applied to claims 1, 3, 4, 5, 7, 8-9, 13-16, 18-20 above, and further in view of Foustoukos (US 2017/0015972-from IDS filed 11/06/2023).
Regarding claim 2, Lavon discloses the method of claim 1 as described above, further comprising washing (flushing) the grown cell mass with the washing media (page 15, ln 23-24, page 24, ln 3-6) and suggest the utilization of pumps for circulation (page 19, ln 15-32).
Lavon does not expressly disclose agitating both the grown cell mass and the washing media and homogenizing the grown cell mass and the washing media utilizing gas.
Foustoukos discloses an integrated system, apparatus and method that allows for the continuous culturing cells under such conditions with minimal physical/chemical disturbance inside the reactor and minimal impact of shear forces on the collected biomass (abstract), comprising agitating both the grown cell mass and the washing media (para 13) and homogenizing the grown cell mass and the washing media utilizing gas (para 28).
Since Lavon teaches methods for producing cultured food products in a bioreactor (pg 4, ln 7-8, 9-11) and Foustoukos discloses an apparatus for agitating and homogenizing cells in culture (abstract, para 13, para 28), it would have been obvious to one of ordinary skill in the art that the apparatus of Foustoukos could be used in the method of Lavon to provide for the benefits of continuous cell culture with minimal physical/chemical disturbance inside the reactor and minimizing the impact of shear forces on the collected biomass. One of ordinary skill in the art would have had a reasonable expectation of success because Foustoukos teach and suggest that their invention is not to be limited to their specific embodiments and may be practiced other than as particularly described (page 7 para 55).
Therefore, the combined teachings of Lavon et al and Foustoukos render obvious Applicant’s invention as claimed.
Response to Arguments
Applicant's arguments filed 05/05/2026 have been fully considered but they are not fully persuasive.
Applicant’s amendments to the claims have overcome the rejection of 35 USC 112b and thus this rejection has been withdrawn.
Applicant argues that the Lavon reference does not render obvious amended independent claims 1 and 7 because Lavon does not teach or suggest growing a cell mass in a cell culture media having a first pH and then using a washing media having a second pH that is higher than the first pH. Applicant asserts that Lavon suggests the opposite of a method or system that can support cell culture media and washing media of different pH levels because Lavon discloses where the pH is maintained in a range of 6.7-7.2 +/- 0.1 at page 35, lines 25-26 and figure 3.
This is not found persuasive. The claims do not require a specific pH to be used in the claimed method and only that the pH of the culture media and the washing media be different and that the second pH is higher than the first. Lavon allows for the pH to be maintained in a range of 6.7-7.2 +/- 0.1 which allows for the media to vary and be different during the exchange process from as little as 0.1 within the described range. Lavon allows for the washing media to be even slightly higher than the culture media as long as both are within the desired range of 6.7-7.2 which meets the claim requirements.
Applicant argues that Lavon does not render obvious amended independent claim 8. Applicant argues that Lavon does not teach or suggest a first exchange media comprising a higher pH relative to the cell culture media and flushing the cell mass with a second exchange media comprising a lower pH relative to the first exchange media. Applicant asserts that Lavon suggests the opposite of a method or system that can support cell culture media and washing media of different pH levels because Lavon discloses where the pH is maintained in a range of 6.7-7.2 +/- 0.1 at page 35, lines 25-26 and figure 3.
This is not found persuasive. The claims do not require a specific pH to be used in the claimed method and only that the pH of the first exchange media and the culture media be different and that the pH is higher in one than the other. Lavon allows for the pH to be maintained in a range of 6.7-7.2 +/- 0.1 which allows for the media to vary and be different during the exchange process from as little as 0.1 within the described range. Lavon allows for the first exchange media to be even slightly higher than a second exchange media as long as both are within the desired range of 6.7-7.2 which meets the claim requirements.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Segeritz et al., “Cell Culture: Growing Cells as Model Systems In Vitro”, Chapter 9, Basic Science Methods for Clinical Researchers, 2017, pp. 151-172.
(Discloses optimal pH for cell culture-see pages 161-162)
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/ Primary Examiner, Art Unit 1631
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