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 18-23 and 25-31 are currently pending.
Claims 18-23 are currently amended.
Claims 25-31 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 1-17 and 24 are cancelled.
Claims 18-23 have been considered on the merits.
Withdrawn Objections/Rejections
The objections made onto claims 19-22 are withdrawn in light of the amendments made in the reply filed 03/19/2026.
The rejections made onto claims 19 and 21 under 35 U.S.C. 112(a) are withdrawn in light of the amendments made in the reply filed on 03/19/2026.
The rejections made onto claims 18-24 under 35 U.S.C. 112(b) are withdrawn in light of the amendments made in the reply filed on 03/19/2026.
The rejection made onto claim 24 under 35 U.S.C. 112(f) are withdrawn in light of the cancelation of claim 24 in the reply filed on 03/19/2026.
Maintained Rejections
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.
Claims 18 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Ott et al (US20140302480A1), in view of Seyedmahmoud et al (Micromachines, 2019).
Claim Interpretation: Claim 23 recites the process by which the claimed animal skeletal muscle satellite cells are obtained. Claim 23 is a product by process claim in which the process of obtaining the animal skeletal muscle satellite cells carries little patentable weight. It is only the product, which is anticipated by the prior art and not the process by which the product was made. This is because the final product (population of obtained animal skeletal muscle satellite cells) is not distinguished by any particular features or characteristics resulting from the process by which it was made. As such, the limitations of the claimed process of obtaining the animal skeletal muscle satellite cells are met by any process of obtaining the animal skeletal muscle satellite cells in the prior art. Patentability of a product-by-process claim is determined by the novelty and nonobviousness of the claimed product itself without consideration of the process for making it which are encompassed by the claimed process of obtaining the animal skeletal muscle satellite cells of claim 23. Thus, any method of obtaining the animal skeletal muscle satellite cells of the art meets the limitations of claim 23.
With regards to claim 18, Ott teaches a method of in vitro 3D cell culture. Ott teaches mixing animal skeletal myoblasts ([0048]), a type of satellite cell, with a bioink which is taught to be a hydrogel which is introduced into a bioreaction chamber ([0065]) which meets the limitation of “placing a printed 3D animal skeletal muscle satellite cell tissue in a “special culture apparatus” as required by claim 18. Ott teaches the “special culture apparatus” to be a bioreactor containing a bioreactor chamber, meeting the limitations of “a 3D biological tissue culture tank” as required by claim 18 (Bioreactor chamber item 1454 of Fig. 14). Ott teaches that the bioreactor contains a supply reservoir which meets the limitations of a “liquid storage tank” as required by claim 18 ([0124] Supply reservoir item 1455). Ott teaches that the supply reservoir is connected to the inflow tube connected to the bioreactor chamber which meets the limitations of a “pipeline” as required by claim 18 ([0124], Fig. 14, and item 1436A). Finally, Ott teaches an opening of the tissue culture tank which seals with the bioreactor chamber and provides needles connected to a cell injector (item 1460 of Fig. 14) extending into the tissue as required by claim 18 ([0020], Fig. 14, item 1460 is cell injector, item 1464 is the tissue, and tubing labeled “a” and “v”, [0122]).
Ott does not teach that the hydrogel/bioink is made of methacrylic gelatin and/or nanocellulose as required by claim 18.
However, Seyedmahmoud teaches a method of 3D printing of functional skeletal muscle tissue using methacrylic gelatin bioinks (abstract). Seyedmahmoud discloses that they found that a GelMa composition was able to provide the optimum niche to induce muscle tissue formation compared to other hydrogel compositions as required by claim 3 (abstract). Additionally, Seyedmahmoud teaches that “gelatin methacryloyl (GelMA) is a known hydrogel with tunable properties that can mimic the native muscle tissue environment” (pg. 2, para 3).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the bioreactor and culture of skeletal myoblasts in a hydrogel taught by Ott with the method of culturing skeletal muscle cells on a methacrylic gelatin hydrogel taught by Seyedmahmoud to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Seyedmahmoud teaches “gelatin methacryloyl (GelMA) is a known hydrogel with tunable properties that can mimic the native muscle tissue environment” (pg. 2, para 3). One of ordinary skill in the art would have a reasonable expectation of success when combining Ott with Seyedmahmoud because both teach the required methods to culture skeletal cells on hydrogel bioinks and because Seyedmahmoud discloses that they found that a GelMa composition was able to provide the optimum niche to induce muscle tissue formation compared to other hydrogel compositions (abstract).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ott et al (US20140302480A1), in view of Seyedmahmoud et al (Micromachines, 2019), as applied to claims 18 and 23 above, in further view of Metzger et al (In Vitro Cellular and Developmental Biology, available online 2019).
With regard to claim 19, the limitations of the independent claim 18 are taught by Ott above.
Ott does not teach that the animal skeletal muscle satellite cells are of porcine origin, that the cells are cultured between 36.5-37.5°C at 5% CO2, that a proliferation medium is used for 1-2 days and then the medium is exchanged for a differentiation medium that is used until the cells differentiation and fuse to form a cultured meat product as required by claim 19.
However, Metzger teaches a method of culturing porcine skeletal muscle satellite cells in which the cells are cultured at 37°C and at 6% CO2 as required by claim 19 (pg. 194, col. 2, para 1). Metzger teaches that the method involves the use of a proliferation medium for 1 day and then the media is exchanged for a differentiation medium that is used for 6 days and the degree of fusion of the cultured tissue is tested as required by claim 19 (pg. 196, col. 1, last para and col. 2, para 1). Metzger teaches that the resultant degrees of fusion are in agreement with other porcine studies (pg. 196, col. 2, para 1).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the bioreactor and culture of skeletal myoblasts in a hydrogel taught by Ott with the method of culturing porcine skeletal muscle cells taught by Metzger to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Metzger teaches that the resultant degrees of fusion are in agreement with other porcine studies (pg. 196, col. 2, para 1). One of ordinary skill in the art would have a reasonable expectation of success when combining Ott with Metzger because both teach the required methods to culture skeletal cells on hydrogels.
The combination of prior art cited above in all rejections under 35 U.S.C. 103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. ___, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
In the present situation, rationale B is more applicable. Metzger differs from the claimed method in that the claimed method requires a 5% CO2 culture environment whereas Metzger teaches 6% CO2 culture environment. One of ordinary skill in the art would recognize that a 1% difference in CO2 concentration in the culture conditions would be a simple substitution of one known element for another to obtain a predictable result. The teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable Ott et al (US20140302480A1), in view of Seyedmahmoud et al (Micromachines, 2019), and Metzger et al (In Vitro Cellular and Developmental Biology, available online 2019) as applied to claims 18 and 19 above, and further in view of Choi et al (Food Science of Animal Resources, July 2020).
With regards to claim 20, the limitations of the independent claim 18 are taught by Ott above.
Ott does not teach that the porcine skeletal muscle satellite cells are cultured in a proliferation medium comprising 8-12 ng/mL EGF, 0.5-2 ng/mL FGF, 0.005-0.015 mg/L insulin, and 0.3-0.5 µg/mL dexamethasone; and that the differentiation medium contains 0.005-0.015 mg/L insulin as required by claim 20.
Metzger teaches that the proliferation medium contains 1 µM insulin (0.0058 mg/L) as required by claim 20(pg. 196, col. 1, para 2 spanning col. 2, para 1). Metzger teaches that the differentiation medium contains 1 µM insulin (0.0058 mg/L) as required by claim 20 (pg. 196, col. 1, para 2 spanning col. 2, para 1). Metzger teaches the use of dexamethasone in the method however it is present in the differentiation medium of Metzger and not the proliferation medium (pg. 196, col. 1, para 2 spanning col. 2, para 1).
Choi teaches about the optimization of culturing conditions for maintaining pig muscle stem cells in vitro (abstract).
Regarding the inclusion of EGF and dexamethasone into the proliferation media, Choi teaches “to find suitable in vitro culture conditions for pig muscle stem cells, we first tested the commercially available media SkGM-2, which includes epidermal growth factor (EGF) and dexamethasone, for human myoblasts. EGF and dexamethasone enhance the proliferation and differentiation capacity of myoblasts in vitro” (pg. 663, para 2). Additionally, Choi teaches that “Dexamethasone is a synthetic glucocorticoid that enhanced the proliferation ability of muscle stem cells via regulation of catabolism” (pg. 665, para 2).
Regarding the inclusion of FGF into the proliferation media, Choi teaches “the proliferating myoblasts are most widely cultured with fibroblast growth factor 2 (FGF2)-supplemented media in vitro. FGF2 is secreted from stromal cells, such as fibroblasts, and it plays a role in the proliferation of the myoblasts in vivo” (pg. 660, para 2).
The combination of prior art cited above in all rejections under 35 U.S.C. 103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. ___, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
In the present situation, rationales A, D, and E are applicable. Metzger differs from the claimed method in that the proliferation medium used does not contain EGF, FGF, or dexamethasone in the concentrations claimed. However, Choi teaches about the optimization of culturing conditions for maintaining pig muscle stem cells in vitro (abstract). Choi provides motivation to include EGF, FGF, and dexamethasone in proliferation medium used for pig muscle stem cells. Additionally, Choi exemplifies that these components are combined according to known methods in the field to yield predictable results and obvious to try through choosing from a finite number of identified cell culture media components with a well known and reasonable expectation of success. The teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ott et al (US20140302480A1), in view of Seyedmahmoud et al (Micromachines, 2019), as applied to claims 18 and 23 above, in further in view of Harding et al (Physiological Reports, 2016).
With regard to claim 21, the limitations of the independent claim 18 are taught by Ott above.
Ott does not teach that the animal skeletal muscle satellite cells are chicken skeletal muscle satellite cells, that are cultured at 40.5-41.5°C in 5% CO2, and after 1-2 days the proliferation medium is replaced with a differentiation medium and further cultured until the cells fuse to form the block-shaped cultured meat as required by claim 21.
However, Harding teaches a method of culturing chicken skeletal muscle satellite cells on gelatin at 41°C in 5% CO2 and after 2 days a proliferation medium is replaced with a differentiation medium and allowed to grow as required by claim 21 (pg. 2, col. 1, para 2). Harding teaches that the chicken breast muscle satellite cells are both sensitive and highly desired as a choice of meat and that “as such, it is essential that poultry producers take into account the effect of temperature on resulting meat quality” (pg. 12, col. 1, para 1).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the bioreactor and culture of skeletal myoblasts in a hydrogel taught by Ott with the method of culturing chicken skeletal muscle cells taught by Harding to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Harding teaches that the chicken breast muscle satellite cells are both sensitive and highly desired as a choice of meat and that “as such, it is essential that poultry producers take into account the effect of temperature on resulting meat quality” (pg. 12, col. 1, para 1). One of ordinary skill in the art would have a reasonable expectation of success when combining Ott with Harding because Ott teaches the necessary methods of culturing muscle satellite cells in a culture apparatus on a hydrogel and Harding teaches the culture of chicken skeletal cells on a gelatin hydrogel.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ott et al (US20140302480A1), in view of Seyedmahmoud et al (Micromachines, 2019) and Harding et al (Physiological Reports, 2016) as applied to claims 18 and 21 above, and further in view of Danoviz et al (Methods Mol Biol., 2012).
With regards to claim 22, the limitations of the independent claim 18 are taught by Ott above.
Ott does not teach that the proliferation medium is McCoy’s 5A medium supplemented with 10-20% chicken serum or FBS, and the differentiation medium used is Mccoy’s 5A medium supplemented with 0-5% chicken serum or FBS as required by claim 22.
Harding teaches that the proliferation medium used is McCoy’s 5A including 10% chicken serum and that the differentiation medium used was a low serum DMEM with 0% chicken serum or FBS as required by claim 22 (pg. 2, col. 1, para 2).
Harding does not teach that the basal medium of the differentiation medium is McCoy’s 5A medium.
However, Danoviz teaches about the typical mediums used in the proliferation of skeletal muscle satellite cells, including chicken skeletal muscle satellite cells (abstract). Danoviz teaches that some variations can be found from laboratory to laboratory with regard to the basic culture media and that “some published protocols rely on first using serum-rich growth medium that supports proliferation followed by a switch to serum-poor medium to support differentiation” (pg. 7, para 6).
The combination of prior art cited above in all rejections under 35 U.S.C. 103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. ___, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
In the present situation, rationale B is most applicable. Harding differs from the claimed method in that the claimed method a basal medium of McCoy’s 5A media be used as the differentiation media. Provided with the teachings of Danoviz, one of ordinary skill in the art would recognize that the differentiation basal medium can differ slightly, especially as long as the proliferation medium contains a higher serum concentration and the differentiation medium contains a low-serum concentration. Therefore, One could replace the DMEM media used as the basal differentiation media in Harding with the McCoy’s 5A media used as a proliferation medium in Harding which would constitute simple substitution of one known element for another to obtain predictable results. The teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 03/19/2026 have been fully considered but they are not persuasive.
Applicant argues (Remarks, pg. 7-9) that the needle described by Ott is a single needle and that the infusion needle of the instant invention is a plurality of infusion needles instead of injection needles and that the infusion needle of this application requires that the needles penetrate the tissue.
In response this argument is not found persuasive. Fig. 14 (cited above) includes item 160 which is an injector and is described at paragraph [0020] (cited above) as being “connected to one or more needles, each needles including at least a portion extending into a tissue scaffold within the bioreactor chamber” which reads on the multiple infusion needles of claim 18. Therefore, the argument is not found persuasive.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
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