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
The text of those sections of Title 35, U.S. Code not included in this action can be found
in a prior Office action.
This application is in response to the papers filed on June 30, 2026. Pursuant to the amendment filed on June 30, 2026, claims 1, 10, 13-16 and 18-22 are currently pending. Claims 1, 13, and 15 have been amended, claims 2-9, 11-12, and 17 have been cancelled, and claims 18-22 are newly filed in Applicant’s amendment filed on June 30, 2026.
Therefore, claims 1, 10, 13-16 and 18-22 are currently under examination to which the following grounds of rejection are applicable.
Priority
The instant application claims foreign priority 35 U.S.C. 119(a)-(d) to Republic of Korea Patent Application Nos. 10-2021-0040443, 10-2021-0040444, and 10-2021-0040445 all filed on March 29, 2021, and to PCT Application No. PCT/KR2022/004437 filed on March 29, 2022. Receipt is acknowledged of untranslated certified copies of papers required by 37 CFR 1.55. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application
Thus, the earliest possible priority for the instant application is March 29, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted June 29, 2026, was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Withdrawn Objections/Rejections in response to Applicants’ arguments or amendments:
Drawings
The drawings were received on June 30, 2026. These drawings are acceptable. The objections to the Drawings filed on October 30, 2023 have been withdrawn accordingly.
Claim Objections
The objection of cancelled claim 12 has been rendered moot.
Claim Rejections - 35 USC § 112
The rejection of cancelled claim 17 rejected under 35 USC § 112 has been rendered moot.
Claim Rejections - 35 USC § 101
The rejection of claim 17 rejected under 35 USC § 101 has been rendered moot.
Claim Rejections - 35 USC § 102
In view of Applicants’ amendment to the claims dated June 30, 2026, wherein claims 2-9, 11-12, and 17 have been cancelled, and claims 1, 13, and 15 being amended, the rejection to claims 1, 10-13, 15-17 rejected under 35 U.S.C.102(a)(1) as being anticipated by Choi et al. (“Comprehensive reviews in food science and food safety 20.1 (2021): 429-457.”) are withdrawn.
Claim Rejections - 35 USC § 103
In view of Applicants’ amendment to the claims dated June 30, 2026, wherein claims 2-9, 11-12, and 17 have been cancelled, and claims 1, 13, and 15 being amended, the rejection to claims 1-5 rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (“Comprehensive reviews in food science and food safety 20.1 (2021): 429-457.”) further in view of Thaloor et al. (Am. J. Physiol. 1999, vol. 277, pp. C320-C329) are withdrawn.
In view of Applicants’ amendment to the claims dated June 30, 2026, wherein claims 2-9, 11-12, and 17 have been cancelled, and claims 1, 13, and 15 being amended, the rejection to claims 1, 6, 7, and 14 rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (“Comprehensive reviews in food science and food safety 20.1 (2021): 429-457.”) further in view of Gheller et al. (Molecular Metabolism. 2021 (Available online: 23 October 2020), vol. 43, 101106, pp. 1-15; of record IDS filed on September 29, 2023) are withdrawn.
In view of Applicants’ amendment to the claims dated June 30, 2026, wherein claims 2-9, 11-12, and 17 have been cancelled, and claims 1, 13, and 15 being amended, the rejection to claims 1, 8, and 9 rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (“Comprehensive reviews in food science and food safety 20.1 (2021): 429-457.”) further in view of Godoy-Parejo et al. (Stem cells 37.8 (2019): 1030-1041) are withdrawn.
The rejections under 35 U.S.C. 102 & 103 have been withdrawn in view of the amendment to the claims in which claim s1 now recites concentrations for insulin, curcumin, and glycine, and states, “wherein the culture medium composition maintains the muscle stem cells in an undifferentiated state and is bFGF (basic fibroblast growth factor)-free.”
Applicants’ arguments are moot in view of the withdrawn rejection. A response to any argument pertaining to a new or maintained rejection can be found below.
New Grounds of Rejection:
Claim Rejections - 35 USC § 103
Claims 1, 10, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wieland et al. (US 2020/0332263 A1) as evidenced by ThermoFisher Scientific (Culture Media Compositions).
Regarding claims 1, 10, and 19-20, Wieland teaches a culture medium composition intended for stem cells that comprises insulin and glycine wherein the insulin is at a concentration of 0.01 μM to less than 10 μM (“insulin is in the range of 0.1 mg/L to 100 mg/L” [converts to approximately 0.0172 µM to 17.218 µM] (par 118-119)) and wherein the glycine is at a concentration of 0.1 mM to less than 100 mM (“glycine 4.5 mg/L to 45 mg/L” [converts to approximately 0.06 mM to 0.6 mM] (par 108). The taught culture media does not comprise FGF-2 (bFGF) yet maintains the stem cells in an undifferentiated state (“In particular, the medium does not require exogenously added FGF-2.” (par 0052, 0095)).
The basal media employed by Wieland is selected from “Dulbecco's Modified Eagle's Medium (DMEM), Ham's F-12, DMEM:F12, Minimal Essential Medium (MEM), Basal Medium Eagle (BME), RPMI 1640, F-10, α Minimal Essential Medium (αMEM), Glasgow's Minimal Essential Medium (G-MEM), and Iscove's Modified Dulbecco's Medium as well as combinations thereof.” (par 101). As evidenced by ThermoFisher Media Formulations sheets for F-12, DMEM, DMEM/F-12, RPMI 1640, F-10, and Iscove's Modified Dulbecco's Medium, glycine is comprised in the respective culture media compositions are within the claimed concentration range as seen at 0.1 mM, 0.4 mM, 0.25 mM, 0.13 mM, 0.1 mM, and 0.4 mM.
Wieland does not teach the composition in view of the claimed intended use for culturing muscle stem cells; however, it is clear based on the structure of the claim that using the composition for culturing is not being actively claimed. MPEP 2111.02 states, “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim.” In the instant case, there are no clear manipulative differences nor structural differences between the culture medium composition taught by Wieland than the one recited in the claims and therefore is expected to function similarly to the instant application’s in culturing muscle stem cells.
In relation to the wherein clause, e.g. “wherein the culture medium composition maintains the muscle stem cells in an undifferentiated state,” there is a reasonable expectation that the taught composition by Wieland would similarly maintain muscle stem cells in an undifferentiated state based on there being no structural differences between the culture media compositions. Furthermore, the wherein clause does not hold any weight when there are no structural elements that are pointed to that cause the claimed effect, i.e. maintain muscle stem cells in an undifferentiated state.
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Wieland et al. (US 2020/0332263 A1) in view of Benedetti et al. (A novel approach for the isolation and long-term expansion of pure satellite cells based on ice-cold treatment." Skeletal Muscle 11.1 (2021): 7) and Choi et al. (“Comprehensive reviews in food science and food safety 20.1 (2021): 429-457.”; of record IDS filed on September 29, 2023) as evidenced by ThermoFisher Scientific (Culture Media Compositions).
The rejection to claims 1, 10, and 19-20 are discussed above wherein Wieland teaches the claimed culture medium composition intended to be used for culturing muscle stem cells.
Regarding claims 13-16, Wieland teaches a method of culturing stem cells in a culture medium composition that comprises insulin and glycine wherein the insulin is at a concentration of 0.01 μM to less than 10 μM (“insulin is in the range of 0.1 mg/L to 100 mg/L” [converts to approximately 0.0172 µM to 17.218 µM] (par 118-119)) and wherein the glycine is at a concentration of 0.1 mM to less than 100 mM (“glycine 4.5 mg/L to 45 mg/L” [converts to approximately 0.06 mM to 0.6 mM] (par 108;136). The taught culture media does not comprise FGF-2 (bFGF) yet maintains the stem cells in an undifferentiated state (“In particular, the medium does not require exogenously added FGF-2.” (par 0052, 0095)).
The basal media employed by Wieland is taught as “Dulbecco's Modified Eagle's Medium (DMEM), Ham's F-12, DMEM:F12, Minimal Essential Medium (MEM), Basal Medium Eagle (BME), RPMI 1640, F-10, α Minimal Essential Medium (αMEM), Glasgow's Minimal Essential Medium (G-MEM), and Iscove's Modified Dulbecco's Medium as well as combinations thereof.” (par 101). As evidenced by ThermoFisher Media Formulations sheets for F-12, DMEM, DMEM/F-12, RPMI 1640, F-10, and Iscove's Modified Dulbecco's Medium, glycine is comprised in the respective culture media compositions are within the claimed concentration range as seen at 0.1 mM, 0.4 mM, 0.25 mM, 0.13 mM, 0.1 mM, and 0.4 mM.
Wieland does not teach the claimed method of culturing muscle stem cells by culturing muscle stem cells isolated from a mammal in a culture medium for culturing muscle stem cells, and wherein the culture medium maintains the muscle stem cells in an undifferentiated state.
Benedetti teaches the isolation and long-term expansion of pure satellite cells based on ice-cold treatment (ICT), wherein the expansion of satellite cells occurs in growth media that comprises DMEM, 20% Horse Serum (Sigma-Aldrich), 3% Chicken Embryo Extract, or in DM containing DMEM 5% Horse Serum, 1% Chicken Embryo Extract (p 3, col 1). The stem cells (SCs) were isolated from hind-limb muscles of 4-8 week old mice or from human biopsies (p 2, col 2). Benedetti describes the “The SCs passaged using the ICT method did not lose their proliferation and differentiation potential and displayed a minimally altered Pax7 and myogenin gene expression” (Fig. 2c, d; p 6, col 1); “The ICT method doubles up as a gentle passaging technique, allowing SC expansion over extended periods of time without compromising their proliferation and differentiation potential.” (abstract). In relation to the culture media composition, Benedetti teaches DMEM which contains glycine as described above as evidenced by ThermoFisher Scientific.
It would have been prima facie obvious for one of ordinary skill in the art at the time of the invention to have modified the cell culturing method of Wieland by incorporating isolated muscle stem cells because it would have been obvious to substitute one known element for another to obtain predictable results. Substituting the claimed muscle stem cells as taught by Benedetti with the stem cells in cell culture media composition of Wieland would have led to predictable results with a reasonable expectation of success because Benedetti teaches the culturing of muscle stem cells does not require FGF-2, and furthermore involves using a culture media that comprises glycine for the expansion of these stem cells wherein the stem cells maintain an undifferentiated state across passages as seen above in Benedetti’s outcomes when isolating using the ICT method. Therefore, there is a reasonable expectation that the substitution of cell types in the process taught by Wieland would lead to a similar outcome as such outcomes are taught for both cell types.
Regarding claim 15, and claim 16 directed to the product, the rejection to claim 13 is applied herein as the limitations are similar, e.g. “culturing muscle stem cells isolated from a mammal in a culture medium for culturing muscle stem cells” and “treating muscle stem cells derived from a non-human animal with a culture medium composition for culturing muscle stem cells”. Benedetti teaches both stem cells isolated from a mammal, and more specifically a non-human animal, and stem cells derived from these animals (mice and humans (p 2, col 2)). Regarding claim 16, the prior art references inherently teach in vitro meat based on teaching the method of claim 15 and due to there being no additional limitations that would differentiate the product obtained from the taught method than what is claimed as “in vitro meat.” Regardless of not explicitly teaching the label of “in vitro meat”, Choi teaches in Figure 1 the method of cultured meat production wherein the final product is in vitro meat, and wherein the process is initiated with isolation of muscle stem cells of which Wieland in view of Benedetti teach.
Claims 1, 10, 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Wieland et al. (US 2020/0332263 A1), as applied to claims 1, 10, 19, and 20, further in view of Thaloor et al. (Am. J. Physiol. 1999, vol. 277, pp. C320-C329; of record IDS filed on September 29, 2023), as evidenced by ThermoFisher Scientific (Culture Media Compositions).
The teachings of Wieland are discussed supra. The rejection to claims 1, 10, and 19-20 describe that Wieland teaches the claimed culture medium composition intended to be used for culturing muscle stem cells, wherein both glycine and insulin at the claimed concentrations are included.
Regarding claims 18, 21, and 22, Wieland does not teach the cell culture media composition as containing curcumin, and furthermore in combination with glycine or insulin.
Thaloor discloses a culture medium comprising curcumin has effects on cultured muscle precursor cells, e.g. myoblasts, to directly stimulate both cell proliferation and differentiation under appropriate conditions (abstract; p 321, col 2; p 324, col 1). The concentration of curcumin during culturing of muscle stem cells can vary, and the effects on muscle tissue regeneration are dose dependent as seen in the highest expression of the relevant gene at the highest curcumin dosage of 10 uM (10 -6M), it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the art of cell culturing.
It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated curcumin in the culture medium composition that comprises both insulin and glycine intended for culturing stem cells as described by Wieland based on Thaloor describing the beneficial role curcumin has on muscle cell proliferation, and therefore there is a reasonable expectation that the inclusion in the cell culture composition would have similar outcomes when similarly culturing muscle stem cells.
Response to Applicants’ Arguments as they apply to rejection of claims under 35 USC § 102 and 103
Applicants’ arguments, see starting on page 5, filed June 30, 2026, with respect to the rejection(s) of:
Claims 1, 10-13, 15-17 rejected as being anticipated by Choi et al.
Claims 1-5 rejected as being unpatentable over Choi as applied to claim 1, and further in view of Thaloor et al.
Claims 1, 6, 7 and 14 rejected as being unpatentable over Choi as applied to claim 1, and further in view of Gheller et al.
Claims 1, 8 and 9 rejected as being unpatentable over Choi as applied to claim 1, and further in view of Godoy-Parejo et al.
have been fully considered and are persuasive. Therefore, the rejections have been withdrawn as described above. However, upon further consideration, new grounds of rejection are made in view of Wieland et al. for claims 1, 10, 19, and 20. The Wieland reference teaches the claimed composition in view of the limitations of the claimed concentrations for glycine and insulin. Wieland in view of Thaloor (of record) are used to teach claims 18, 21-22 wherein the culture media further comprises curcumin. Wieland in view of Benedetti are used to teach using the claimed cell culture composition for culturing muscle stem cells. The only reference that remains from the previous Office Action is Thaloor et al. for teaching curcumin.
In relation to the arguments pertaining to Thaloor, in which the Applicant describes Thaloor not teaching the claimed concentration, and furthermore the Applicant’s claimed concentration achieves “a superior effect to maintain undifferentiated state of the muscle cells”, the arguments are not convincing. The rejection with Thaloor describes that optimization of the curcumin dosage can be optimized based on cell proliferation, and moreover the range recited by the Applicant is broad. The claimed range is from 0.01-8 µM, yet the argument recites Figure 6 that lists a range with values of 0 (control), 0.1, 1, 5, 8, and 10 µM wherein the increased Oct4 expression (sign of differentiation ability) was only observed at the 1µM and 5µM dosages. Therefore, the claimed unexpected result in relation to a particular dosage of curcumin is not reflected in the claims. Secondly, and more importantly, the claim is directed to a cell culture composition that does not comprise muscle stem cells, and therefore the unexpected effects of the curcumin on these stem cells are not given weight as the cells themselves are not required in the claimed composition for claims 1, 10, 18-22.
Conclusion
Claims 1, 10, 13-16 and 18-22 are rejected. 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.
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/MICHAEL ANGELO RIGA/Examiner, Art Unit 1634
/TERESA E KNIGHT/Primary Examiner, Art Unit 1634
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